Somatoform DisordersBIOFEESOMATONCT04807933
Neurovegetative Decoupling in Somatoform Disorders : Biofeedback Interest
A study testing Heart rate variability Biofeedback [HRV-BFB] in people with Somatoform Disorders and Irritable Bowel Syndrome, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Evaluation of the physiological and clinical effects of the biofeedback training with patients suffering from somatoform disorders, depending on their neurovegetative profile related to a visceral-brain decoupling. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Somatoform Disorders, Irritable Bowel Syndrome, Psychogenic Non-Epileptic Seizure
- What is being tested?
- Heart rate variability Biofeedback [HRV-BFB]
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteFrance
- Study dates
- 16 Mar 2021to 5 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Somatoform disorders (IBS or PNES) diagnosis must be established by the partner doctors
- Participants must have home computer
- Participants must be of the age of majority
- Participants must be registered for social security
- Participants must have signed an informed consent
Who cannot join
- Specially protected participants (under clauses L1121-5 and L1121-8 by the code of public health): juveniles, pregnant womens, nursing mothers, law's protection peoples
- Participants suffering from a severe psychiatric disease needing specialised attention
- Participants suffering from or have suffered from a severe disease causing autonomic dysfunctions (heart failure, asthma, blood disease, renal failure, peripheral neuropathy, vagotomy, thyroid disorder, alcoholism, liver disease, amyloidosis)
- Participants taking medication which could be impact autonomic nervous system activity (anticholinergic, antiarrhythmics, clonidine, beta-blockers, tricyclic anti-depressants, metronidazole)
- Participants placing under judicial or administrative supervisions
- Participants were compensated more than 4500 euros because of his research protocol participation concerning human over the 12 months prior to the actual study
- Participants being not be able to contact in emergency
- Participants being in an exclusion period from another study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neurovegetative Decoupling in the Visceral-brain Axis and Cognitive-emotional Vulnerability in Somatoform Disorders : Interest of Vagal Biofeedback
Evaluation of the physiological and clinical effects of the biofeedback training with patients suffering from somatoform disorders, depending on their neurovegetative profile related to a visceral-brain decoupling.
Read the detailed description
Somatoform disorders [SD] are defined as physiological function or organ disturbances unexplained by a specific diagnosis criterion. Some approaches have recently defended the idea of common factors of vulnerability behind the large variability of the clinical symptoms regarding the SD. In this context, the lead of the neurovegetative disturbances started receiving attention following some studies that suggested the autonomic nervous system [ANS] disturbances concerning a somatoform disorder, independently of its form. Two different neurovegetative endophenotypes (individual autonomic profiles) were highlighted: a functional neurovegetative profile (high vagal tone) and a dysfunctional neurovegetative profile (low vagal tone).
A dysfunctional neurovegetative profile could be accompanied by a chronic decoupling in the brain-visceral axis according as the ANS is considered as a bidirectional communication system linked the central nervous system [CNS] and the viscera. Depending on the types of the neurovegetative profiles, different degrees of cognitive-emotional vulnerability and a higher or a lower level of acceptance of the illness could be supposed. Finally, recent findings defend the idea of the traumatic experiences as a determining factor to develop a SD.
In accordance to the last notions regarding the SD, some therapeutic approaches could be interesting specifically techniques focusing on the vagal nerve. In this context, biofeedback [BFB] could provide a powerful method to restore the clinical and physiological impairments.
As a consequence, the main objective is to evaluate the physiological and clinical effects of the BFB training with patients suffering from SD: Irritable Bowel Syndrome [IBS] or Psychogenic Non Epileptic Seizure [PNES]. The investigators make the prediction that the patients will be more or less responding to the biofeedback depending on their neurovegetative profile. A clustering will be performed in advance to identify the patients having a dysfunctional neurovegetative profile and patients having a functional neurovegetative profile. It will also permit to the investigators to confirm the hypothesis about the existence of two neurovegetative profiles related to a visceral-brain decoupling concerning the SD, independently of its form. To attest to it, 2 types of somatoform disorders will be analyzed: the irritable bowel syndrome manifesting by peripheral symptoms and the psychogenic non-epileptic seizures manifesting by central symptoms. Then the investigators will carry out a psycho-social exploration to demonstrate a higher cognitive-emotional vulnerability and a higher traumatic event incidence in this particular population, depending on their autonomic profiles.
- Being tested
- Heart rate variability Biofeedback [HRV-BFB]
- Keywords
- Autonomic nervous system, Brain-gut axis, Endophenotype, Cognitive-emotional vulnerability, Traumas, Biofeedback, Heart rate variability, Vagal tone, Central nervous system, Enteric nervous system, Early life events, Somatoform disorders, Stress, Irritable bowel syndrome, Psychogenic non epileptic seizures
- Medical subject headings
- Somatoform Disorders, Irritable Bowel Syndrome, Psychogenic Nonepileptic Seizures, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart rate variability Biofeedback [HRV-BFB]Behavioural
Also called Complementary technique
BFB consists of a physiological recording used as a visual physiological feedback that can teach us how to control our physiology, which is naturally unconscious and uncontrollable. The BFB focused on the heart rate variability (HRV-BFB) could regulate the autonomic nervous system (vagal tone and sympathetic-parasympathetic balance) and the emotional state. The HRV BFB has received several clinical and experimental confirmations as a physiological remediation method. It is an innovative and non-pharmacological therapy frequently used to relieve stress.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group (BFB training) | Experimental | The participants assigned to the experimental group will do the biofeedback training using the Emwave software during the intervention period (T2-T3). The biofeedback software (Emwave Pro®) includes a photoplethysmography sensor that can be positioned on the earlobe. The installation of the program and the explanations needed for using it, will be done during the second session (T2). According to the guidelines, a fractional training is proposed 5 minutes, 3 times a day for 24 days (T2-T3). Receives: Behavioral: Heart rate variability Biofeedback [HRV-BFB] |
| Control group (no BFB training) | No intervention | The participants assigned to the experimental group will not do a specific exercise during the intervention period (T2-T3). |
What is being measured
The primary outcome is the main question the study is designed to answer.
High frequency [HF] (0.15-0.40 Hz)
High frequency (0.15-0.40 Hz), frequency-domain parameter
HF will be measured using the electrocardiogram [ECG]:
ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].
Measured: Day 1 (T1)
High frequency [HF] (0.15-0.40 Hz)
High frequency (0.15-0.40 Hz), frequency-domain parameter
HF will be measured using the electrocardiogram [ECG]:
ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].
Measured: Up to 25 days from T1 (T2)
High frequency [HF] (0.15-0.40 Hz)
High frequency (0.15-0.40 Hz), frequency-domain parameter
HF will be measured using the electrocardiogram [ECG]:
ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].
Measured: Up to 52 days from T1 (T3)
Root mean square of successive RR interval differences [RMSSD]
Root mean square of successive RR interval differences, temporal-domain parameter
RMSSD will be measured using the electrocardiogram [ECG]:
ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].
Measured: Day 1 (T1)
Root mean square of successive RR interval differences [RMSSD]
Root mean square of successive RR interval differences, temporal-domain parameter
RMSSD will be measured using the electrocardiogram [ECG]:
ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].
Measured: Up to 25 days from T1 (T2)
Root mean square of successive RR interval differences [RMSSD]
Root mean square of successive RR interval differences, temporal-domain parameter
RMSSD will be measured using the electrocardiogram [ECG]:
ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].
Measured: Up to 52 days from T1 (T3)
Secondary outcomes (84)
Low frequency [LF] (0.04-0.15 Hz)
Low frequency (0.04-0.15 Hz), frequency-domain parameter
LF will be measured using the electrocardiogram [ECG]:
ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].
Measured: Day 1 (T1)
Low frequency [LF] (0.04-0.15 Hz)
Low frequency (0.04-0.15 Hz), frequency-domain parameter
LF will be measured using the electrocardiogram [ECG]:
ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].
Measured: Up to 25 days from T1 (T2)
Low frequency [LF] (0.04-0.15 Hz)
Low frequency (0.04-0.15 Hz), frequency-domain parameter
LF will be measured using the electrocardiogram [ECG]:
ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].
Measured: Up to 52 days from T1 (T3)
Low frequency [LF] 0.1 Hertz (0.075-0.108Hz)
Spectral power of the low-frequency 0.1Hz band (0.075-0.108Hz), frequency-domain parameter
LF-0.1Hz will be measured using the electrocardiogram [ECG]:
ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].
Measured: Day 1 (T1)
Low frequency [LF] 0.1 Hertz (0.075-0.108Hz)
Spectral power of the low-frequency 0.1Hz band (0.075-0.108Hz), frequency-domain parameter
LF-0.1Hz will be measured using the electrocardiogram [ECG]:
ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].
Measured: Up to 25 days from T1 (T2)
Low frequency [LF] 0.1 Hertz (0.075-0.108Hz)
Spectral power of the low-frequency 0.1Hz band (0.075-0.108Hz), frequency-domain parameter
LF-0.1Hz will be measured using the electrocardiogram [ECG]:
ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].
Measured: Up to 52 days from T1 (T3)
Total power (0-0.40 Hz)
Total power of the 0-0.40 Hertz band, frequency-domain parameter
Total power will be measured using the electrocardiogram [ECG]:
ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].
Measured: Day 1 (T1)
Total power (0-0.40 Hz)
Total power of the 0-0.40 Hertz band, frequency-domain parameter
Total power will be measured using the electrocardiogram [ECG]:
ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].
Measured: Up to 25 days from T1 (T2)
Total power (0-0.40 Hz)
Total power of the 0-0.40 Hertz band, frequency-domain parameter
Total power will be measured using the electrocardiogram [ECG]:
ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].
Measured: Up to 52 days from T1 (T3)
Ratio Low frequency / High frequency [LF / HF]
Ratio of LF to HF power, frequency-domain parameter
LF/HF will be measured using the electrocardiogram [ECG]:
ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].
Measured: Day 1 (T1)
Ratio Low frequency / High frequency [LF / HF]
Ratio of LF to HF power, frequency-domain parameter
LF/HF will be measured using the electrocardiogram [ECG]:
ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].
Measured: Up to 25 days from T1 (T2)
Ratio Low frequency / High frequency [LF / HF]
Ratio of LF to HF power, frequency-domain parameter
LF/HF will be measured using the electrocardiogram [ECG]:
ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].
Measured: Up to 52 days from T1 (T3)
Standard deviation of all NN intervals [SDNN]
Standard deviation of all NN intervals, temporal-domain parameter
SDNN will be measured using the electrocardiogram [ECG]:
ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].
Measured: Day 1 (T1)
Standard deviation of all NN intervals [SDNN]
Standard deviation of all NN intervals, temporal-domain parameter
SDNN will be measured using the electrocardiogram [ECG]:
ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].
Measured: Up to 25 days from T1 (T2)
Standard deviation of all NN intervals [SDNN]
Standard deviation of all NN intervals, temporal-domain parameter
SDNN will be measured using the electrocardiogram [ECG]:
ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].
Measured: Up to 52 days from T1 (T3)
Skin conductance responses [SCR] frequency
Skin conductance responses [SCR] frequency : number of the spontaneous galvanic skin responses by periods
SCR will be measured using the Galvanic skin responses [GSR]:
GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR).
Measured: Day 1 (T1)
Skin conductance responses [SCR] frequency
Skin conductance responses [SCR] frequency : number of the spontaneous galvanic skin responses by periods
SCR will be measured using the Galvanic skin responses [GSR]:
GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR).
Measured: Up to 25 days from T1 (T2)
Skin conductance responses [SCR] frequency
Skin conductance responses [SCR] frequency : number of the spontaneous galvanic skin responses by periods
SCR will be measured using the Galvanic skin responses [GSR]:
GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR).
Measured: Up to 52 days from T1 (T3)
Skin conductance responses [SCR] amplitude
Skin conductance responses amplitude: amplitude of the spontaneous galvanic skin responses by periods
SCR will be measured using the Galvanic skin responses [GSR]:
GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR).
Measured: Day 1 (T1)
Skin conductance responses [SCR] amplitude
Skin conductance responses amplitude: amplitude of the spontaneous galvanic skin responses by periods
SCR will be measured using the Galvanic skin responses [GSR]:
GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR).
Measured: Up to 25 days from T1 (T2)
Skin conductance responses [SCR] amplitude
Skin conductance responses amplitude: amplitude of the spontaneous galvanic skin responses by periods
SCR will be measured using the Galvanic skin responses [GSR]:
GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR).
Measured: Up to 52 days from T1 (T3)
Integrated skin conductance responses [ISCR]
Integrated skin conductance responses [ISCR]: area of the galvanic skin responses identified on the signal
ISCR will be measured using the Galvanic skin responses [GSR]:
GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR).
Measured: Day 1 (T1)
Integrated skin conductance responses [ISCR]
Integrated skin conductance responses [ISCR]: area of the galvanic skin responses identified on the signal
ISCR will be measured using the Galvanic skin responses [GSR]:
GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR).
Measured: Up to 25 days from T1 (T2)
Integrated skin conductance responses [ISCR]
Integrated skin conductance responses [ISCR]: area of the galvanic skin responses identified on the signal
ISCR will be measured using the Galvanic skin responses [GSR]:
GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR).
Measured: Up to 52 days from T1 (T3)
Pulsatility index variation [PI]
Pulsatility index variation [PI] : transit time flow
PI will be measured using the Photoplethysmography [PPG]:
PPG data will be recorded using a finger sensor. Physiological data recorded are related to the adrenergic sympathetic tone and allowing a record of the blood pulse waves associated with the heart rate.
Measured: Day 1 (T1)
Pulsatility index variation [PI]
Pulsatility index variation [PI] : transit time flow
PI will be measured using the Photoplethysmography [PPG]:
PPG data will be recorded using a finger sensor. Physiological data recorded are related to the adrenergic sympathetic tone and allowing a record of the blood pulse waves associated with the heart rate.
Measured: Up to 25 days from T1 (T2)
Pulsatility index variation [PI]
Pulsatility index variation [PI] : transit time flow
PI will be measured using the Photoplethysmography [PPG]:
PPG data will be recorded using a finger sensor. Physiological data recorded are related to the adrenergic sympathetic tone and allowing a record of the blood pulse waves associated with the heart rate.
Measured: Up to 52 days from T1 (T3)
Breathing rate
Breathing rate by cycles per minute
The breathing rate will be measured using a breathing belt.
Measured: Day 1 (T1)
Breathing rate
Breathing rate by cycles per minute
The breathing rate will be measured using a breathing belt.
Measured: Up to 25 days from T1 (T2)
Breathing rate
Breathing rate by cycles per minute
The breathing rate will be measured using a breathing belt.
Measured: Up to 52 days from T1 (T3)
Dominant power (0-0.15Hz)
Dominant power of the 0-0.15 Hertz band, frequency-domain parameter
Dominant power will be measured using the electrogastrogram [EGG]:
EGG data will be recorded using 6 single use and adhesive electrodes placed on the skin of the abdomen.
Measured: Day 1 (T1)
Dominant power (0-0.15Hz)
Dominant power of the 0-0.15 Hertz band, frequency-domain parameter
Dominant power will be measured using the electrogastrogram [EGG]:
EGG data will be recorded using 6 single use and adhesive electrodes placed on the skin of the abdomen.
Measured: Up to 25 days from T1 (T2)
Dominant power (0-0.15Hz)
Dominant power of the 0-0.15 Hertz band, frequency-domain parameter
Dominant power will be measured using the electrogastrogram [EGG]:
EGG data will be recorded using 6 single use and adhesive electrodes placed on the skin of the abdomen.
Measured: Up to 52 days from T1 (T3)
Total power (0-0.15Hz)
Total power of the 0-0.15 Hertz band, frequency-domain parameter
Total power will be measured using the electrogastrogram [EGG]:
EGG data will be recorded using 6 single use and adhesive electrodes placed on the skin of the abdomen.
Measured: Day 1 (T1)
Total power (0-0.15Hz)
Total power of the 0-0.15 Hertz band, frequency-domain parameter
Total power will be measured using the electrogastrogram [EGG]:
EGG data will be recorded using 6 single use and adhesive electrodes placed on the skin of the abdomen.
Measured: Up to 25 days from T1 (T2)
Total power (0-0.15Hz)
Total power of the 0-0.15 Hertz band, frequency-domain parameter
Total power will be measured using the electrogastrogram [EGG]:
EGG data will be recorded using 6 single use and adhesive electrodes placed on the skin of the abdomen.
Measured: Up to 52 days from T1 (T3)
Slow-waves frequency (physiological outcome)
Slow-waves frequency per minute, frequency-domain parameter
Slow-wave frequency will be measured using the electrogastrogram [EGG]:
EGG data will be recorded using 6 single use and adhesive electrodes placed on the skin of the abdomen.
Measured: Day 1 (T1)
Slow-waves frequency (physiological outcome)
Slow-waves frequency per minute, frequency-domain parameter
Slow-wave frequency will be measured using the electrogastrogram [EGG]:
EGG data will be recorded using 6 single use and adhesive electrodes placed on the skin of the abdomen.
Measured: Up to 25 days from T1 (T2)
Slow-waves frequency (physiological outcome)
Slow-waves frequency per minute, frequency-domain parameter
Slow-wave frequency will be measured using the electrogastrogram [EGG]:
EGG data will be recorded using 6 single use and adhesive electrodes placed on the skin of the abdomen.
Measured: Up to 52 days from T1 (T3)
Delta frequency (0-4Hz)
Delta frequency 0-4 Hertz band
Delta frequency will be measured using the electroencephalogram [EEG]:
EEG data will be recorded using a EEG headsets including 64 electrodes. The EEG is related to the brain activity generated by the neural functioning.
Measured: Day 1 (T1)
Delta frequency (0-4Hz)
Delta frequency 0-4 Hertz band
Delta frequency will be measured using the electroencephalogram [EEG]:
EEG data will be recorded using a EEG headsets including 64 electrodes. The EEG is related to the brain activity generated by the neural functioning.
Measured: Up to 25 days from T1 (T2)
Delta frequency (0-4Hz)
Delta frequency 0-4 Hertz band
Delta frequency will be measured using the electroencephalogram [EEG]:
EEG data will be recorded using a EEG headsets including 64 electrodes. The EEG is related to the brain activity generated by the neural functioning.
Measured: Up to 52 days from T1 (T3)
Theta frequency (4-7Hz)
Theta frequency 4-7 Hertz band
Theta frequency will be measured using the electroencephalogram [EEG]:
EEG data will be recorded using a EEG headsets including 64 electrodes. The EEG is related to the brain activity generated by the neural functioning.
Measured: Day 1 (T1)
Theta frequency (4-7Hz)
Theta frequency 4-7 Hertz band
Theta frequency will be measured using the electroencephalogram [EEG]:
EEG data will be recorded using a EEG headsets including 64 electrodes. The EEG is related to the brain activity generated by the neural functioning.
Measured: Up to 25 days from T1 (T2)
Theta frequency (4-7Hz)
Theta frequency 4-7 Hertz band
Theta frequency will be measured using the electroencephalogram [EEG]:
EEG data will be recorded using a EEG headsets including 64 electrodes. The EEG is related to the brain activity generated by the neural functioning.
Measured: Up to 52 days from T1 (T3)
Alpha frequency (8-12Hz)
Alpha frequency 8-12 Hertz band
Alpha frequency will be measured using the electroencephalogram [EEG]:
EEG data will be recorded using a EEG headsets including 64 electrodes. The EEG is related to the brain activity generated by the neural functioning.
Measured: Day 1 (T1)
Alpha frequency (8-12Hz)
Alpha frequency 8-12 Hertz band
Alpha frequency will be measured using the electroencephalogram [EEG]:
EEG data will be recorded using a EEG headsets including 64 electrodes. The EEG is related to the brain activity generated by the neural functioning.
Measured: Up to 25 days from T1 (T2)
Alpha frequency (8-12Hz)
Alpha frequency 8-12 Hertz band
Alpha frequency will be measured using the electroencephalogram [EEG]:
EEG data will be recorded using a EEG headsets including 64 electrodes. The EEG is related to the brain activity generated by the neural functioning.
Measured: Up to 52 days from T1 (T3)
Beta frequency (13-30Hz)
Beta frequency 13-30 Hertz band
Beta frequency will be measured using the electroencephalogram [EEG]:
EEG data will be recorded using a EEG headsets including 64 electrodes. The EEG is related to the brain activity generated by the neural functioning.
Measured: Day 1 (T1)
Beta frequency (13-30Hz)
Beta frequency 13-30 Hertz band
Beta frequency will be measured using the electroencephalogram [EEG]:
EEG data will be recorded using a EEG headsets including 64 electrodes. The EEG is related to the brain activity generated by the neural functioning.
Measured: Up to 25 days from T1 (T2)
Beta frequency (13-30Hz)
Beta frequency 13-30 Hertz band
Beta frequency will be measured using the electroencephalogram [EEG]:
EEG data will be recorded using a EEG headsets including 64 electrodes. The EEG is related to the brain activity generated by the neural functioning.
Measured: Up to 52 days from T1 (T3)
Gamma frequency (>30Hz)
Gamma frequency >30 Hertz band
Gamma frequency will be measured using the electroencephalogram [EEG]:
EEG data will be recorded using a EEG headsets including 64 electrodes. The EEG is related to the brain activity generated by the neural functioning.
Measured: Day 1 (T1)
Gamma frequency (>30Hz)
Gamma frequency >30 Hertz band
Gamma frequency will be measured using the electroencephalogram [EEG]:
EEG data will be recorded using a EEG headsets including 64 electrodes. The EEG is related to the brain activity generated by the neural functioning.
Measured: Up to 25 days from T1 (T2)
Gamma frequency (>30Hz)
Gamma frequency >30 Hertz band
Gamma frequency will be measured using the electroencephalogram [EEG]:
EEG data will be recorded using a EEG headsets including 64 electrodes. The EEG is related to the brain activity generated by the neural functioning.
Measured: Up to 52 days from T1 (T3)
Alexithymia score
Alexithymia score will be measured using the Bermond-Vorst Alexithymia Questionnaire B version (BVAQ-B; Vorst \& Bermond, 2001; French version Deborde et al., 2004). The subscale as considered as a trait scale including 20 items.
Measured: Up to 16 days from T2
Neuroticism score
Neuroticism score will be measured using the Big Five Inventory-Neuroticism (BFI-N; John et al., 1991; French version Plaisant et al., 2005). The subscale as considered as a trait scale including 8 items.
Measured: Up to 16 days from T1
Trait and state anxiety scores
The trai and state anxiety scores will be measured using the State-Trait Anxiety Inventory (STAI Y-AB) (Spielberger et al., 1983; French version Bruchon-Schweitzer \& Paulhan, 1990). The scale includes 40 items.
Measured: Up to 8 days from T1
Style of coping
The style of coping will be measured using the Brief Cope (Carver, 1997; French version Muller \& Spitz, 2003). We will use it in its trait version. The subscale as considered as a trait scale including 28 items.
Measured: Up to 16 days from T1
Positive affectivity score
Positive affectivity score will be measured using the Positive And Negative Affect Schedule (PANAS; Watson et al., 1988; French version Caci \& Bayle, 2007). To measure a global affective state, a score of positivity will be calculated by subtracting negative affect score from positive affect score. The subscale as considered as a state scale including 20 items.
Measured: Day 1 (T1)
Positive affectivity score
Positive affectivity score will be measured using the Positive And Negative Affect Schedule (PANAS; Watson et al., 1988; French version Caci \& Bayle, 2007). To measure a global affective state, a score of positivity will be calculated by subtracting negative affect score from positive affect score. The subscale as considered as a state scale including 20 items.
Measured: Up to 25 days from T1 (T2)
Positive affectivity score
Positive affectivity score will be measured using the Positive And Negative Affect Schedule (PANAS; Watson et al., 1988; French version Caci \& Bayle, 2007). To measure a global affective state, a score of positivity will be calculated by subtracting negative affect score from positive affect score. The subscale as considered as a state scale including 20 items.
Measured: Up to 52 days from T1 (T3)
Depressive symptoms score
The depressive symptoms score will be measured using the Center for Epidemiologic Studies-Depression Scale (CES-D; Radloff, 1977; French version Führer \& Rouillon, 1989). The subscale as considered as a state scale including 20 items.
Measured: Day 1 (T1)
Depressive symptoms score
The depressive symptoms score will be measured using the Center for Epidemiologic Studies-Depression Scale (CES-D; Radloff, 1977; French version Führer \& Rouillon, 1989). The subscale as considered as a state scale including 20 items.
Measured: Up to 25 days from T1 (T2)
Depressive symptoms score
The depressive symptoms score will be measured using the Center for Epidemiologic Studies-Depression Scale (CES-D; Radloff, 1977; French version Führer \& Rouillon, 1989). The subscale as considered as a state scale including 20 items.
Measured: Up to 52 days from T1 (T3)
Perceived-stress level
The perceived-stress level will be measured using the Perceived Stress Scale (PSS; Cohen et al., 1983; French version Bellighausen et al., 2009). The subscale as considered as a state scale including 10 items.
Measured: Day 1 (T1)
Perceived-stress level
The perceived-stress level will be measured using the Perceived Stress Scale (PSS; Cohen et al., 1983; French version Bellighausen et al., 2009). The subscale as considered as a state scale including 10 items.
Measured: Up to 25 days from T1 (T2)
Perceived-stress level
The perceived-stress level will be measured using the Perceived Stress Scale (PSS; Cohen et al., 1983; French version Bellighausen et al., 2009). The subscale as considered as a state scale including 10 items.
Measured: Up to 52 days from T1 (T3)
Coping flexibility
The coping flexibility score will be measured using the Coping Flexibility Scale (CFS; Kato, 2012). The CFS measures the coping flexibility including 10 items. The subscale as considered as a state scale.
Measured: Day 1 (T1)
Coping flexibility
The coping flexibility score will be measured using the Coping Flexibility Scale (CFS; Kato, 2012). The CFS measures the coping flexibility including 10 items. The subscale as considered as a state scale.
Measured: Up to 25 days from T1 (T2)
Coping flexibility
The coping flexibility score will be measured using the Coping Flexibility Scale (CFS; Kato, 2012). The CFS measures the coping flexibility including 10 items. The subscale as considered as a state scale.
Measured: Up to 52 days from T1 (T3)
Metacoping
The metacoping score will be measured using a visual analogue scale (VAS). The VAS was developed by ourselves to measure the perceived effectiveness of coping by asking: " how strategies used by yourself to cope with the situation were efficient? ". The participants will have to rate from 0 (no efficacy) to 10 (maximum of efficacy). The subscale as considered as a state scale.
Measured: Day 1 (T1)
Metacoping
The metacoping score will be measured using a visual analogue scale (VAS). The VAS was developed by ourselves to measure the perceived effectiveness of coping by asking: " how strategies used by yourself to cope with the situation were efficient? ". The participants will have to rate from 0 (no efficacy) to 10 (maximum of efficacy). The subscale as considered as a state scale.
Measured: Up to 25 days from T1 (T2)
Metacoping
The metacoping score will be measured using a visual analogue scale (VAS). The VAS was developed by ourselves to measure the perceived effectiveness of coping by asking: " how strategies used by yourself to cope with the situation were efficient? ". The participants will have to rate from 0 (no efficacy) to 10 (maximum of efficacy). The subscale as considered as a state scale.
Measured: Up to 52 days from T1 (T3)
Social support score
The social support score will be measured using the Social Support Questionnaire short version (SSQ6; Sarason et al., 1987a; French version Bruchon-Schweitzer et al., 2003). The subscale as considered as a trait scale including 6 items.
Measured: Up to 8 days from T1
Interceptive sensitivity score
The interceptive sensitivity score will be measured using the Multidimensional Assessment of Interoceptive Awareness second version (MAIA-2; Mehling et al., 2018). The subscale as considered as a trait scale including 37 items.
Measured: Up to 8 days from T1
Life satisfaction score
The life satisfaction score will be measured using the Satisfaction With Life Scale (SWLS; Diener et al., 1985; French version Blais et al., 1989). The subscale as considered as a state scale including 5 items.
Measured: Day 1 (T1)
Life satisfaction score
The life satisfaction score will be measured using the Satisfaction With Life Scale (SWLS; Diener et al., 1985; French version Blais et al., 1989). The subscale as considered as a state scale including 5 items.
Measured: Up to 25 days from T1 (T2)
Life satisfaction score
The life satisfaction score will be measured using the Satisfaction With Life Scale (SWLS; Diener et al., 1985; French version Blais et al., 1989). The subscale as considered as a state scale including 5 items.
Measured: Up to 52 days from T1 (T3)
Negative impact scores
The negative impact score will be measured using the Life Experiences Survey (LES; Sarason et al., 1978). The subscale as considered as a trait scale including 50 items. In this study a modified version of the LES will be used, whereby subjects documented the presence and perceived impact of adulthood life events that had occurred since 18 years of age to the time of completion of the survey. For the purposes of this study, 3 scores will be generated from this survey: the number of negatively perceived life events, the negative impact score determined by the sum of the impact scores of negatively perceived life events alone (higher scores indicate greater negative impact), and the total impact score determined by the sum of the impact scores of both negatively and positively perceived life events (higher scores indicate an overall more positive impact and lower scores indicate an overall more negative impact of all adulthood life events).
Measured: Up to 16 days from T2
Frequency, severity and intensity scores
The frequency, severity and intensity scores will be measured using the Daily Hassles Scale (DHS; Kanner et al., 1981). The subscale as considered as a trait scale including 117 items.
Measured: Up to 8 days from T2
Child Abuse scores
The child abuse scores will be measured using the Childhood Trauma Questionnaire-Short Form (CTQ; Bernstein et al., 2003). The subscale as considered as a trait scale including 28 items.
Measured: Up to 16 days from T1
Acceptance score
The acceptance score will be measured using the Illness Cognition Questionnaire for chronic disease (ICQ-18; Evers et al., 2001). The subscale as considered as a state scale including 18 items.
Measured: Day 1 (T1)
Acceptance score
The acceptance score will be measured using the Illness Cognition Questionnaire for chronic disease (ICQ-18; Evers et al., 2001). The subscale as considered as a state scale including 18 items.
Measured: Up to 25 days from T1 (T2)
Acceptance score
The acceptance score will be measured using the Illness Cognition Questionnaire for chronic disease (ICQ-18; Evers et al., 2001). The subscale as considered as a state scale including 18 items.
Measured: Up to 52 days from T1 (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start16 Mar 2021
- Primary completion5 Jul 2023
- Study completion5 Sep 2023
Why it stopped: The clinical trial is finished
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Somatoform DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study requires 3 sessions (T1 / T2 / T3) with at least 24 days between each. The period (24 days) between the first session and the second session (T1-T2) will be considered as the control period. During the period, the participants will practice none exercise. The period (24 days) between the second session and the third session (T2-T3) will be considered as the intervention period. At the end of the second session (T2), the participants will be separated into two inter-subject groups: an experimental group performing BFB technique (3X5 min per day) in the intervention period (T2-T3) and a control group not performing a specific exercise in the intervention period (T2-T3).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratoire de Psychologie et NeuroCognition, Laboratoire interuniversitaire de psychologie - LIP-PC2S
- Responsible party
- Principal investigator, Essaiclinique_BIOFEESOMATO, University Hospital, Grenoble
- Investigators
- Bruno BONAZ, Pr, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04807933
- Sponsor's protocol ID
- 2020-A02155-34
- Acronym
- BIOFEESOMATO
- Status last verified
- Dec 2024
- First submitted
- 1 Mar 2021
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Heart rate variability: standards of measurement, physiological interpretation and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Circulation. 1996 Mar 1;93(5):1043-65. No abstract available.
PubMed 8598068Laborde S, Mosley E, Thayer JF. Heart Rate Variability and Cardiac Vagal Tone in Psychophysiological Research - Recommendations for Experiment Planning, Data Analysis, and Data Reporting. Front Psychol. 2017 Feb 20;8:213. doi: 10.3389/fpsyg.2017.00213. eCollection 2017.
PubMed 28265249Muller L, Spitz E. [Multidimensional assessment of coping: validation of the Brief COPE among French population]. Encephale. 2003 Nov-Dec;29(6):507-18. French.
PubMed 15029085Mehling WE, Acree M, Stewart A, Silas J, Jones A. The Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAIA-2). PLoS One. 2018 Dec 4;13(12):e0208034. doi: 10.1371/journal.pone.0208034. eCollection 2018.
PubMed 30513087Varon C, Morales J, Lazaro J, Orini M, Deviaene M, Kontaxis S, Testelmans D, Buyse B, Borzee P, Sornmo L, Laguna P, Gil E, Bailon R. A Comparative Study of ECG-derived Respiration in Ambulatory Monitoring using the Single-lead ECG. Sci Rep. 2020 Mar 31;10(1):5704. doi: 10.1038/s41598-020-62624-5.
PubMed 32235865de Vroege L, Emons WHM, Sijtsma K, van der Feltz-Cornelis CM. Psychometric Properties of the Bermond-Vorst Alexithymia Questionnaire (BVAQ) in the General Population and a Clinical Population. Front Psychiatry. 2018 Apr 23;9:111. doi: 10.3389/fpsyt.2018.00111. eCollection 2018.
PubMed 29740350Bulut NS, Wurz A, Yorguner Kupeli N, Carkaxhiu Bulut G, Sungur MZ. Heart rate variability response to affective pictures processed in and outside of conscious awareness: Three consecutive studies on emotional regulation. Int J Psychophysiol. 2018 Jul;129:18-30. doi: 10.1016/j.ijpsycho.2018.05.006. Epub 2018 May 19.
PubMed 29787784Schumann A, Kohler S, Brotte L, Bar KJ. Effect of an eight-week smartphone-guided HRV-biofeedback intervention on autonomic function and impulsivity in healthy controls. Physiol Meas. 2019 Jul 1;40(6):064001. doi: 10.1088/1361-6579/ab2065.
PubMed 31071705Sarason IG, Johnson JH, Siegel JM. Assessing the impact of life changes: development of the Life Experiences Survey. J Consult Clin Psychol. 1978 Oct;46(5):932-46. doi: 10.1037//0022-006x.46.5.932. No abstract available.
PubMed 701572Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.
PubMed 3397865
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurovegetative Decoupling in the Visceral-brain Axis and Cognitive-emotional Vulnerability in Somatoform Disorders : Interest of Vagal Biofeedback
- ClinicalTrials.gov ID
- NCT04807933
- Acronym / sponsor ID
- BIOFEESOMATO / 2020-A02155-34
- Keywords
- Autonomic nervous system, Brain-gut axis, Endophenotype, Cognitive-emotional vulnerability, Traumas, Biofeedback, Heart rate variability, Vagal tone
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The clinical trial is finished
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Laboratoire de Psychologie et NeuroCognition, Laboratoire interuniversitaire de psychologie - LIP-PC2S
- Study start
- 16 Mar 2021 (actual)
- Primary completion
- 5 Jul 2023 (actual)
- Study completion
- 5 Sep 2023 (actual)
- First posted
- 19 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of the physiological and clinical effects of the biofeedback training with patients suffering from somatoform disorders, depending on their neurovegetative profile related to a visceral-brain decoupling.
Detailed description
Somatoform disorders [SD] are defined as physiological function or organ disturbances unexplained by a specific diagnosis criterion. Some approaches have recently defended the idea of common factors of vulnerability behind the large variability of the clinical symptoms regarding the SD. In this context, the lead of the neurovegetative disturbances started receiving attention following some studies that suggested the autonomic nervous system [ANS] disturbances concerning a somatoform disorder, independently of its form. Two different neurovegetative endophenotypes (individual autonomic profiles) were highlighted: a functional neurovegetative profile (high vagal tone) and a dysfunctional neurovegetative profile (low vagal tone).
A dysfunctional neurovegetative profile could be accompanied by a chronic decoupling in the brain-visceral axis according as the ANS is considered as a bidirectional communication system linked the central nervous system [CNS] and the viscera. Depending on the types of the neurovegetative profiles, different degrees of cognitive-emotional vulnerability and a higher or a lower level of acceptance of the illness could be supposed. Finally, recent findings defend the idea of the traumatic experiences as a determining factor to develop a SD.
In accordance to the last notions regarding the SD, some therapeutic approaches could be interesting specifically techniques focusing on the vagal nerve. In this context, biofeedback [BFB] could provide a powerful method to restore the clinical and physiological impairments.
As a consequence, the main objective is to evaluate the physiological and clinical effects of the BFB training with patients suffering from SD: Irritable Bowel Syndrome [IBS] or Psychogenic Non Epileptic Seizure [PNES]. The investigators make the prediction that the patients will be more or less responding to the biofeedback depending on their neurovegetative profile. A clustering will be performed in advance to identify the patients having a dysfunctional neurovegetative profile and patients having a functional neurovegetative profile. It will also permit to the investigators to confirm the hypothesis about the existence of two neurovegetative profiles related to a visceral-brain decoupling concerning the SD, independently of its form. To attest to it, 2 types of somatoform disorders will be analyzed: the irritable bowel syndrome manifesting by peripheral symptoms and the psychogenic non-epileptic seizures manifesting by central symptoms. Then the investigators will carry out a psycho-social exploration to demonstrate a higher cognitive-emotional vulnerability and a higher traumatic event incidence in this particular population, depending on their autonomic profiles.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study requires 3 sessions (T1 / T2 / T3) with at least 24 days between each. The period (24 days) between the first session and the second session (T1-T2) will be considered as the control period. During the period, the participants will practice none exercise. The period (24 days) between the second session and the third session (T2-T3) will be considered as the intervention period. At the end of the second session (T2), the participants will be separated into two inter-subject groups: an experimental group performing BFB technique (3X5 min per day) in the intervention period (T2-T3) and a control group not performing a specific exercise in the intervention period (T2-T3).
| Arm | Type | Receives |
|---|---|---|
| Experimental group (BFB training) | Experimental | Behavioral: Heart rate variability Biofeedback [HRV-BFB]The participants assigned to the experimental group will do the biofeedback training using the Emwave software during the intervention period (T2-T3). The biofeedback software (Emwave Pro®) includes a photoplethysmography sensor that can be positioned on the earlobe. The installation of the program and the explanations needed for using it, will be done during the second session (T2). According to the guidelines, a fractional training is proposed 5 minutes, 3 times a day for 24 days (T2-T3). |
| Control group (no BFB training) | No intervention | –The participants assigned to the experimental group will not do a specific exercise during the intervention period (T2-T3). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Somatoform disorders (IBS or PNES) diagnosis must be established by the partner doctors
- Participants must have home computer
- Participants must be of the age of majority
- Participants must be registered for social security
- Participants must have signed an informed consent
Key exclusion criteria (8 listed)
- Specially protected participants (under clauses L1121-5 and L1121-8 by the code of public health): juveniles, pregnant womens, nursing mothers, law's protection peoples
- Participants suffering from a severe psychiatric disease needing specialised attention
- Participants suffering from or have suffered from a severe disease causing autonomic dysfunctions (heart failure, asthma, blood disease, renal failure, peripheral neuropathy, vagotomy, thyroid disorder, alcoholism, liver disease, amyloidosis)
- Participants taking medication which could be impact autonomic nervous system activity (anticholinergic, antiarrhythmics, clonidine, beta-blockers, tricyclic anti-depressants, metronidazole)
- Participants placing under judicial or administrative supervisions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heart rate variability Biofeedback [HRV-BFB]Also: Complementary techniqueBFB consists of a physiological recording used as a visual physiological feedback that can teach us how to control our physiology, which is naturally unconscious and uncontrollable. The BFB focused on the heart rate variability (HRV-BFB) could regulate the autonomic nervous system (vagal tone and sympathetic-parasympathetic balance) and the emotional state. The HRV BFB has received several clinical and experimental confirmations as a physiological remediation method. It is an innovative and non-pharmacological therapy frequently used to relieve stress. | Behavioural | Experimental group (BFB training) |
Primary outcome
High frequency [HF] (0.15-0.40 Hz)
Time frame: Day 1 (T1)
High frequency (0.15-0.40 Hz), frequency-domain parameter HF will be measured using the electrocardiogram [ECG]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].
High frequency [HF] (0.15-0.40 Hz)
Time frame: Up to 25 days from T1 (T2)
High frequency (0.15-0.40 Hz), frequency-domain parameter HF will be measured using the electrocardiogram [ECG]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].
High frequency [HF] (0.15-0.40 Hz)
Time frame: Up to 52 days from T1 (T3)
High frequency (0.15-0.40 Hz), frequency-domain parameter HF will be measured using the electrocardiogram [ECG]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].
Root mean square of successive RR interval differences [RMSSD]
Time frame: Day 1 (T1)
Root mean square of successive RR interval differences, temporal-domain parameter RMSSD will be measured using the electrocardiogram [ECG]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].
Root mean square of successive RR interval differences [RMSSD]
Time frame: Up to 25 days from T1 (T2)
Root mean square of successive RR interval differences, temporal-domain parameter RMSSD will be measured using the electrocardiogram [ECG]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].
Root mean square of successive RR interval differences [RMSSD]
Time frame: Up to 52 days from T1 (T3)
Root mean square of successive RR interval differences, temporal-domain parameter RMSSD will be measured using the electrocardiogram [ECG]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].
84 secondary outcomes
Low frequency [LF] (0.04-0.15 Hz)
Time frame: Day 1 (T1)
Low frequency [LF] (0.04-0.15 Hz)
Time frame: Up to 25 days from T1 (T2)
Low frequency [LF] (0.04-0.15 Hz)
Time frame: Up to 52 days from T1 (T3)
Low frequency [LF] 0.1 Hertz (0.075-0.108Hz)
Time frame: Day 1 (T1)
Low frequency [LF] 0.1 Hertz (0.075-0.108Hz)
Time frame: Up to 25 days from T1 (T2)
Low frequency [LF] 0.1 Hertz (0.075-0.108Hz)
Time frame: Up to 52 days from T1 (T3)
Total power (0-0.40 Hz)
Time frame: Day 1 (T1)
Total power (0-0.40 Hz)
Time frame: Up to 25 days from T1 (T2)
Total power (0-0.40 Hz)
Time frame: Up to 52 days from T1 (T3)
Ratio Low frequency / High frequency [LF / HF]
Time frame: Day 1 (T1)
Ratio Low frequency / High frequency [LF / HF]
Time frame: Up to 25 days from T1 (T2)
Ratio Low frequency / High frequency [LF / HF]
Time frame: Up to 52 days from T1 (T3)
Standard deviation of all NN intervals [SDNN]
Time frame: Day 1 (T1)
Standard deviation of all NN intervals [SDNN]
Time frame: Up to 25 days from T1 (T2)
Standard deviation of all NN intervals [SDNN]
Time frame: Up to 52 days from T1 (T3)
Skin conductance responses [SCR] frequency
Time frame: Day 1 (T1)
Skin conductance responses [SCR] frequency
Time frame: Up to 25 days from T1 (T2)
Skin conductance responses [SCR] frequency
Time frame: Up to 52 days from T1 (T3)
Skin conductance responses [SCR] amplitude
Time frame: Day 1 (T1)
Skin conductance responses [SCR] amplitude
Time frame: Up to 25 days from T1 (T2)
Skin conductance responses [SCR] amplitude
Time frame: Up to 52 days from T1 (T3)
Integrated skin conductance responses [ISCR]
Time frame: Day 1 (T1)
Integrated skin conductance responses [ISCR]
Time frame: Up to 25 days from T1 (T2)
Integrated skin conductance responses [ISCR]
Time frame: Up to 52 days from T1 (T3)
Pulsatility index variation [PI]
Time frame: Day 1 (T1)
Pulsatility index variation [PI]
Time frame: Up to 25 days from T1 (T2)
Pulsatility index variation [PI]
Time frame: Up to 52 days from T1 (T3)
Breathing rate
Time frame: Day 1 (T1)
Breathing rate
Time frame: Up to 25 days from T1 (T2)
Breathing rate
Time frame: Up to 52 days from T1 (T3)
Dominant power (0-0.15Hz)
Time frame: Day 1 (T1)
Dominant power (0-0.15Hz)
Time frame: Up to 25 days from T1 (T2)
Dominant power (0-0.15Hz)
Time frame: Up to 52 days from T1 (T3)
Total power (0-0.15Hz)
Time frame: Day 1 (T1)
Total power (0-0.15Hz)
Time frame: Up to 25 days from T1 (T2)
Total power (0-0.15Hz)
Time frame: Up to 52 days from T1 (T3)
Slow-waves frequency (physiological outcome)
Time frame: Day 1 (T1)
Slow-waves frequency (physiological outcome)
Time frame: Up to 25 days from T1 (T2)
Slow-waves frequency (physiological outcome)
Time frame: Up to 52 days from T1 (T3)
Delta frequency (0-4Hz)
Time frame: Day 1 (T1)
Results and safety
The study was stopped early (reason given: The clinical trial is finished). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Background: PubMed 8598068Heart rate variability: standards of measurement, physiological interpretation and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Circulation. 1996 Mar 1;93(5):1043-65. No abstract available.
- Background: PubMed 28265249Laborde S, Mosley E, Thayer JF. Heart Rate Variability and Cardiac Vagal Tone in Psychophysiological Research - Recommendations for Experiment Planning, Data Analysis, and Data Reporting. Front Psychol. 2017 Feb 20;8:213. doi: 10.3389/fpsyg.2017.00213. eCollection 2017.
- Background: PubMed 15029085Muller L, Spitz E. [Multidimensional assessment of coping: validation of the Brief COPE among French population]. Encephale. 2003 Nov-Dec;29(6):507-18. French.
- Background: PubMed 30513087Mehling WE, Acree M, Stewart A, Silas J, Jones A. The Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAIA-2). PLoS One. 2018 Dec 4;13(12):e0208034. doi: 10.1371/journal.pone.0208034. eCollection 2018.
- Background: PubMed 32235865Varon C, Morales J, Lazaro J, Orini M, Deviaene M, Kontaxis S, Testelmans D, Buyse B, Borzee P, Sornmo L, Laguna P, Gil E, Bailon R. A Comparative Study of ECG-derived Respiration in Ambulatory Monitoring using the Single-lead ECG. Sci Rep. 2020 Mar 31;10(1):5704. doi: 10.1038/s41598-020-62624-5.
- Background: PubMed 29740350de Vroege L, Emons WHM, Sijtsma K, van der Feltz-Cornelis CM. Psychometric Properties of the Bermond-Vorst Alexithymia Questionnaire (BVAQ) in the General Population and a Clinical Population. Front Psychiatry. 2018 Apr 23;9:111. doi: 10.3389/fpsyt.2018.00111. eCollection 2018.
- Background: PubMed 29787784Bulut NS, Wurz A, Yorguner Kupeli N, Carkaxhiu Bulut G, Sungur MZ. Heart rate variability response to affective pictures processed in and outside of conscious awareness: Three consecutive studies on emotional regulation. Int J Psychophysiol. 2018 Jul;129:18-30. doi: 10.1016/j.ijpsycho.2018.05.006. Epub 2018 May 19.
- Background: PubMed 31071705Schumann A, Kohler S, Brotte L, Bar KJ. Effect of an eight-week smartphone-guided HRV-biofeedback intervention on autonomic function and impulsivity in healthy controls. Physiol Meas. 2019 Jul 1;40(6):064001. doi: 10.1088/1361-6579/ab2065.
- Background: PubMed 701572Sarason IG, Johnson JH, Siegel JM. Assessing the impact of life changes: development of the Life Experiences Survey. J Consult Clin Psychol. 1978 Oct;46(5):932-46. doi: 10.1037//0022-006x.46.5.932. No abstract available.
- Background: PubMed 3397865Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.
- Vorst, Harrie C.M, et Bob Bermond. " Validity and Reliability of the Bermond-Vorst Alexithymia Questionnaire ". Personality and Individual Differences 30, no 3 (février 2001): 413 34.Link provided by the sponsor.
- Plaisant O, Srivastava S, Mendelsohn GA, Debray Q, John OP. Relations entre le Big Five Inventory franc¸ais et le manuel diagnostique des troubles mentaux dans un échantillon clinique franc¸ais. Ann Med Psychol 2005;163:161-7.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruno BONAZ, Pr principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heart rate variability Biofeedback [HRV-BFB] in people with Somatoform Disorders and Irritable Bowel Syndrome, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The clinical trial is finished). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
High frequency [HF] (0.15-0.40 Hz) (time frame: Day 1 (T1)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04807933, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.