DyspneaSensopnée2NCT04815317
Sensory and Emotional Modulation of Dyspnea Under Artificial Ventilation in the Intensive Care Unit
A study testing Auditive stimulation and Sensitive stimulation in people with Dyspnea, run by Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil at 1 site in France.
Trial summary
Rationale: Half of the patients receiving mechanical ventilation in the intensive care unit (ICU) have moderate to severe dyspnea. This dyspnea has a negative impact on the duration of mechanical ventilation, on patients' comfort and could be involved in the genesis of post-traumatic stress syndromes, a frequent… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyspnea
- What is being tested?
- Auditive stimulation and Sensitive stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 26 Nov 2019to 26 Nov 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mechanical ventilation : invasive for at least 48 hours or non-invasive for at least 24 hours, sequential or continuous
- Dyspnea ≥ 4 on a visual analogic scale (VAS) from 0 to 10
- Absence of delirium (evaluated by the CAM-ICU score) ;
- Communicative patient
Who cannot join
- Patients on ECMO or decarboxylation ;
- Patients on long-term left ventricular support;
- Patients postoperatively following any surgery (pain from the procedure may interfere with dyspnea);
- Protected minors and adults;
- Pregnant women.
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Pneumologie et Réanimation Médicale, Groupe Hospitalier Pitié Salpêtrière
Paris, 75013
About this study
Rationale: Half of the patients receiving mechanical ventilation in the intensive care unit (ICU) have moderate to severe dyspnea. This dyspnea has a negative impact on the duration of mechanical ventilation, on patients' comfort and could be involved in the genesis of post-traumatic stress syndromes, a frequent complication of intensive care. Modifying ventilation parameters does not always relieve dyspnea and administering morphine prolongs the duration of mechanical ventilation. Dyspnea has, in addition to its sensory component, an emotional component. The possibility to distract the patients' attention or to modulate their emotions in order to relieve their dyspnea could therefore represent an innovative therapeutic alternative devoid of side effects.
Objectives: To evaluate the effect of auditory and sensory extra respiratory stimuli on the sensation of dyspnea in intensive care patients undergoing mechanical, invasive or non-invasive ventilation.
Read more
Methods: 45 intensive care patients under artificial ventilation will be exposed, according to their randomization arm, to the following two stimuli for a duration of 10 minutes:
- standard relaxing music piece versus "pink" noise;
- fresh air on the face versus fresh air on the thigh. The effect of this stimulus will be compared to a randomized control, these two conditions will be separated by a wash-out period.
An pressure support (+5) increment will be performed to ensure comparability of subsequent experimental sequences and their effect on dyspnea.
Dyspnea will be assessed in terms of intensity (visual analog scale) and characterized sensorially. Will also be evaluated during the different conditions: pain, anxiety and stress (sympathetic/parasympathetic balance) and extra-diaphragmatic electromyographic activity.
Ethical framework: research involving the human person at risk and minimal constraints (physiology study that does not entail any risk for the patients).
Expected results and prospects: the investigators hypothesize that pleasant extra-respiratory sensory stimulation significantly reduces the intensity of dyspnea in artificially ventilated patients without any change in ventilator settings and pharmacological intervention. This reduction in dyspnea is associated with decreased anxiety and stress levels.
This study will bring new, easy-to-use and side-effect-free tools to the therapeutic arsenal for the relief of dyspnea in mechanically ventilated patients.
Read the detailed description
Dyspnea or "shortness of breath" is a major symptom that alters the quality of life of patients who suffer from it. It is a multimodal sensation that integrates psychological, social and environmental factors (1). Recent studies have shown that dyspnea and pain share a number of characteristics (2). In intensive care, dyspnea affects up to half of the patients under mechanical ventilation (3). However, unlike pain, which has been the subject of numerous studies in intensive care, relieving it is not a usual therapeutic objective.
In recent years, despite considerable progress in the understanding of the mechanisms of dyspnea, there has been no major advance in the therapeutic tools aimed at relieving it. The best evaluated and most prescribed drugs currently available to relieve dyspnea are morphine drugs (4). However, there is no formal proof of their long-term effectiveness and side effects such as the respiratory depressant effect make them difficult to use. Non-pharmacological tools integrating the sensory but also emotional dimension of dyspnea have also been developed. The investigators find parallel medicines (acupuncture, hypnosis...) but also extra respiratory stimulation techniques (thoracic vibrations, administration of fresh air to the face...) which modulate and relieve dyspnea with a certain success (1).
Optimizing tools to relieve dyspnea patients is therefore a priority. To date, the pharmacological arsenal is limited due to the number of effective molecules and their side effects. Non-pharmacological tools allowing to modulate the sensory and emotional components of dyspnea represent a therapeutic alternative that deserves to be explored. This is the purpose of this project.
Half of the patients undergoing mechanical ventilation in intensive care have moderate to severe dyspnea. This dyspnea has a negative impact on the duration of mechanical ventilation, on patient comfort and on the incidence of post-traumatic stress disorder. Changing ventilation parameters does not always relieve dyspnea, and administering morphine prolongs the duration of mechanical ventilation. The possibility of distracting the patients' attention or modulating their emotions in order to relieve their dyspnea seems to be a simple way to improve their comfort and could represent an innovative therapeutic alternative.
In this context, the investigators hypothesize that pleasant extra respiratory sensory stimulation relieves dyspnea in artificially ventilated patients without any change in ventilator settings and pharmacological intervention.
The main objective of our study is to demonstrate, in dyspneic patients undergoing artificial ventilation, a decrease in dyspnea under the effect of :
- listening to a piece of music versus pink noise;
- the application of cold air to the face versus the application of cold air to the calf.
The secondary objectives are to evaluate the effect of extra-respiratory stimuli on :
- the quality of dyspnea (thirst for air, excessive respiratory work, concentration)
- the intensity of secondary emotional responses (anxiety, fear).
- the electromyographic activity of extra-diaphragmatic inspiratory muscles
STUDY CONDITIONS The experimental sessions will take place in the patient's room, in the Intensive Care Unit of Prof. T. Similowski.
Patients will have been previously informed orally and in writing and will have signed the informed consent.
TYPE OF STUDY It is research involving the human person with minimal risk and constraints, interventional, open, randomized.
POPULATION, SAMPLING All subjects, without exception, must understand French and have read and understood the appropriate information leaflet and signed the consent form.
It is research involving the human person with minimal risk and constraints, interventional, open, randomized.
PATIENT MONITORING During the experimental sessions, an investigating physician will systematically be present in the room. Any tolerance abnormality (agitation, disturbance of vigilance, SpO2 <88%, tachycardia greater than 130/min or mean blood pressure < 60mmHG) will lead to the interruption of the experimental session.
EXPERIMENTAL PROTOCOL Each patient will participate in a single one-hour experimental session that will take place as follows.
The type of stimulation administered to the patient will be determined by randomization. The order of administration of the stimulation and its control will also be determined by randomization.
Each experimental session will consist of ten sequences of 10 minutes each.
The experimental sequences will proceed as follows:
BASIC: recording of ventilation parameters, constants, ECG, skin conductance and psycho-sensory parameters at baseline.
PRESSURE SUPPORT INCREMENT: An pressure support (+5) increment will be performed to ensure comparability of subsequent experimental sequences and their effect on dyspnea.
WASH OUT: new recording in basic ventilation. Sensory and psycho-sensory parameters are again collected as above.
STIMULUS 1 case or control: administration of extra-respiratory stimulation 1 or its control depending on the randomization arm. Sensory and psycho-sensory variables are measured as above.
WASH OUT: new recording in basic ventilation. Sensory and psycho-sensory parameters are again collected as above.
STIMULUS 1 case or control: administration of extra-respiratory stimulation 1 or its control according to the randomization arm. Sensory and psycho-sensory variables are measured as above.
WASH OUT: new recording in basic ventilation. Sensory and psycho-sensory parameters are again collected as above.
STIMULUS 2 cases or control: administration of extra respiratory stimulation 1 or its control according to the randomization arm. Sensory and psycho-sensory variables are measured as above.
WASH OUT: new recording in basic ventilation. Sensory and psycho-sensory parameters are again collected as above.
STIMULUS 2 cases or control: administration of extra respiratory stimulation 1 or its control according to the randomization arm. Sensory and psycho-sensory variables are measured as above.
RECOVERY: Interruption of the stimulation or its control is interrupted. Recording of ventilatory, sensory and psycho-sensory parameters after return to baseline.
- Conditions
- Dyspnea
- Being tested
- Auditive stimulation, Sensitive stimulation, Auditory control, Sensitive control
- Keywords
- Patient-ventilator interaction, Inspiratory muscles, Electromyogram, Mechanical ventilation
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auditive stimulationOther
The auditory stimulation will consist of listening to relaxing pieces of music from MP3 files from the International Center for Music Therapy (Noisy le Grand, France).
Listening will be done through noise-cancelling headphones (PLANTRONICS, Gamecom 780, Santa Cruz, California, USA) for 10 minutes.
Sensitive stimulationOther
Sensitive stimulation will consist of administering fresh air to the patient's face by means of a fan without blades (DYSON AM01, Malmesbury, UK) for 10 minutes.
Auditory controlOther
The auditory control condition will consist of listening to a pink noise. The pink noise, like the white noise, is a normalized noise. The sound produced on a TV set that is out of adjustment during the "snow effect" is a representative example of such noise. Pink noise is a random signal whose power spectral density decreases by 3dB per octave. This signal is closer to the sensitivity of the ear than white noise.
Sensitive controlOther
The sensitive control condition will be achieved by administering fresh air on the calf.
| Study group | Role | What they receive |
|---|---|---|
| Basal | Active comparator | The impact of these stimulations will be compared to that of a control stimulus.
The auditory control condition will consist of listening to a pink noise. The pink noise, like the white noise, is a normalized noise. The sound produced on a TV set that is out of adjustment during the "snow effect" is a representative example of such noise. Pink noise is a random signal whose power spectral density decreases by 3dB per octave. This signal is closer to the sensitivity of the ear than white noise.
The sensitive control condition will be achieved by administering fresh air on the calf.
An pressure support (+5) increment will be performed to ensure comparability of subsequent experimental sequences and their effect on dyspnea. Receives: Other: Auditory control; Other: Sensitive control |
| Intervention | Experimental | Patients will be subjected to sensory stimuli that may be auditory or sensitive.
The sensory stimulations will be administered by a research nurse. The auditory stimulation will consist of listening to relaxing pieces of music from MP3 files from the International Center for Music Therapy (Noisy le Grand, France).
Listening will be done through noise-cancelling headphones (PLANTRONICS, Gamecom 780, Santa Cruz, California, USA) for 10 minutes.
Sensitive stimulation will consist of administering fresh air to the patient's face by means of a fan without blades (DYSON AM01, Malmesbury, UK) for 10 minutes. Receives: Other: Auditive stimulation; Other: Sensitive stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection and quantification of dyspnea intensity change
Dyspnea will initially be searched for with absence or presence. If present, it will then be quantified using a visual analog scale graduated from 0 ("absence of respiratory discomfort") to 10 ("maximum respiratory discomfort").
Measured: At the baseline and during the interventions
Secondary outcomes (3)
Anxiety
Anxiety will be sought initially. If it is present, it will then be evaluated using a visual analog scale graduated from 0 ("absence of anxiety") to 10 ("maximum anxiety").
Measured: At the baseline and during the interventions
Mesure of pain
Patients in resuscitation can be painful, which can interfere with the perception of dyspnea. Pain will be sought first.If it is present, it will then be assessed using a visual analogue scale graduated from 0 ("no pain") to 10 ("maximum pain").
Discomfort caused by the stimulus The inconvenience caused by the stimuli applied to the patient will be quantified, if any, using a visual analog scale graduated from 0 ("no inconvenience") to 10 ("maximum inconvenience").
Measured: At the baseline and during the interventions
Electromyogram of extra-diaphragmatic inspiratory muscles
Electromyogram (EMG) of the extra-diaphragmatic inspiratory muscles: the amplitude of the EMG signal of the extra-diaphragmatic inspiratory muscles is proportional to the intensity of the dyspnea. It will be collected by self-adhesive surface electrodes of the same type as those usually used to collect the ECG signal in intensive care patients. A distance of 2 cm will separate the two electrodes. The position of the electrodes will depend on the muscle whose EMG activity is collected: scalene muscles, intercostal parasternal muscles, Alae nasi muscles, etc. The EMG signal will be amplified (PowerLab, AD Instruments, Hastings, UK), then sampled at a frequency of 10 kHz and finally filtered between 40 and 500 Hz.
Measured: At the baseline and during the interventions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start26 Nov 2019
- Primary completion27 Aug 2021
- Study completion26 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for DyspneaStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandre DEMOULE, MD, PhD, Principal investigator, Groupe Hospitalier Universitaire APHP - Sorbonne Université Site Pitié-Salpêtrière (bâtiment Eole)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04815317
- Sponsor's protocol ID
- 2019-A01532-55
- Acronym
- Sensopnée2
- Status last verified
- Jan 2022
- First submitted
- 10 Feb 2021
- Last updated
- 2 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Parshall MB, Schwartzstein RM, Adams L, Banzett RB, Manning HL, Bourbeau J, Calverley PM, Gift AG, Harver A, Lareau SC, Mahler DA, Meek PM, O'Donnell DE; American Thoracic Society Committee on Dyspnea. An official American Thoracic Society statement: update on the mechanisms, assessment, and management of dyspnea. Am J Respir Crit Care Med. 2012 Feb 15;185(4):435-52. doi: 10.1164/rccm.201111-2042ST.
PubMed 22336677Morelot-Panzini C, Demoule A, Straus C, Zelter M, Derenne JP, Willer JC, Similowski T. Dyspnea as a noxious sensation: inspiratory threshold loading may trigger diffuse noxious inhibitory controls in humans. J Neurophysiol. 2007 Feb;97(2):1396-404. doi: 10.1152/jn.00116.2006. Epub 2006 Jul 26.
PubMed 16870842Schmidt M, Demoule A, Polito A, Porchet R, Aboab J, Siami S, Morelot-Panzini C, Similowski T, Sharshar T. Dyspnea in mechanically ventilated critically ill patients. Crit Care Med. 2011 Sep;39(9):2059-65. doi: 10.1097/CCM.0b013e31821e8779.
PubMed 21572329Abernethy AP, Currow DC, Frith P, Fazekas BS, McHugh A, Bui C. Randomised, double blind, placebo controlled crossover trial of sustained release morphine for the management of refractory dyspnoea. BMJ. 2003 Sep 6;327(7414):523-8. doi: 10.1136/bmj.327.7414.523.
PubMed 12958109Lansing RW, Gracely RH, Banzett RB. The multiple dimensions of dyspnea: review and hypotheses. Respir Physiol Neurobiol. 2009 May 30;167(1):53-60. doi: 10.1016/j.resp.2008.07.012. Epub 2008 Jul 25.
PubMed 18706531Bureau C, Nierat MC, Decavele M, Rivals I, Dangers L, Beurton A, Virolle S, Deleris R, Delemazure J, Mayaux J, Morelot-Panzini C, Dres M, Similowski T, Demoule A. Sensory interventions to relieve dyspnoea in critically ill mechanically ventilated patients. Eur Respir J. 2024 Jan 18;63(1):2202215. doi: 10.1183/13993003.02215-2022. Print 2024 Jan.
PubMed 37678956
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensory and Emotional Modulation of Dyspnea Under Artificial Ventilation in the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT04815317
- Acronym / sponsor ID
- Sensopnée2 / 2019-A01532-55
- Conditions
- Dyspnea
- Keywords
- Patient-ventilator interaction, Inspiratory muscles, Electromyogram, Mechanical ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le SommeilUniversity, hospital or other
- Study start
- 26 Nov 2019 (actual)
- Primary completion
- 27 Aug 2021 (actual)
- Study completion
- 26 Nov 2021 (actual)
- First posted
- 25 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.
Rationale: Half of the patients receiving mechanical ventilation in the intensive care unit (ICU) have moderate to severe dyspnea. This dyspnea has a negative impact on the duration of mechanical ventilation, on patients' comfort and could be involved in the genesis of post-traumatic stress syndromes, a frequent complication of intensive care. Modifying ventilation parameters does not always relieve dyspnea and administering morphine prolongs the duration of mechanical ventilation. Dyspnea has, in addition to its sensory component, an emotional component. The possibility to distract the patients' attention or to modulate their emotions in order to relieve their dyspnea could therefore represent an innovative therapeutic alternative devoid of side effects.
Objectives: To evaluate the effect of auditory and sensory extra respiratory stimuli on the sensation of dyspnea in intensive care patients undergoing mechanical, invasive or non-invasive ventilation.
Methods: 45 intensive care patients under artificial ventilation will be exposed, according to their randomization arm, to the following two stimuli for a duration of 10 minutes:
- standard relaxing music piece versus "pink" noise;
- fresh air on the face versus fresh air on the thigh. The effect of this stimulus will be compared to a randomized control, these two conditions will be separated by a wash-out period.
An pressure support (+5) increment will be performed to ensure comparability of subsequent experimental sequences and their effect on dyspnea.
Dyspnea will be assessed in terms of intensity (visual analog scale) and characterized sensorially. Will also be evaluated during the different conditions: pain, anxiety and stress (sympathetic/parasympathetic balance) and extra-diaphragmatic electromyographic activity.
Ethical framework: research involving the human person at risk and minimal constraints (physiology study that does not entail any risk for the patients).
Expected results and prospects: the investigators hypothesize that pleasant extra-respiratory sensory stimulation significantly reduces the intensity of dyspnea in artificially ventilated patients without any change in ventilator settings and pharmacological intervention. This reduction in dyspnea is associated with decreased anxiety and stress levels.
This study will bring new, easy-to-use and side-effect-free tools to the therapeutic arsenal for the relief of dyspnea in mechanically ventilated patients.
Detailed description
Dyspnea or "shortness of breath" is a major symptom that alters the quality of life of patients who suffer from it. It is a multimodal sensation that integrates psychological, social and environmental factors (1). Recent studies have shown that dyspnea and pain share a number of characteristics (2). In intensive care, dyspnea affects up to half of the patients under mechanical ventilation (3). However, unlike pain, which has been the subject of numerous studies in intensive care, relieving it is not a usual therapeutic objective.
In recent years, despite considerable progress in the understanding of the mechanisms of dyspnea, there has been no major advance in the therapeutic tools aimed at relieving it. The best evaluated and most prescribed drugs currently available to relieve dyspnea are morphine drugs (4). However, there is no formal proof of their long-term effectiveness and side effects such as the respiratory depressant effect make them difficult to use. Non-pharmacological tools integrating the sensory but also emotional dimension of dyspnea have also been developed. The investigators find parallel medicines (acupuncture, hypnosis...) but also extra respiratory stimulation techniques (thoracic vibrations, administration of fresh air to the face...) which modulate and relieve dyspnea with a certain success (1).
Optimizing tools to relieve dyspnea patients is therefore a priority. To date, the pharmacological arsenal is limited due to the number of effective molecules and their side effects. Non-pharmacological tools allowing to modulate the sensory and emotional components of dyspnea represent a therapeutic alternative that deserves to be explored. This is the purpose of this project.
Half of the patients undergoing mechanical ventilation in intensive care have moderate to severe dyspnea. This dyspnea has a negative impact on the duration of mechanical ventilation, on patient comfort and on the incidence of post-traumatic stress disorder. Changing ventilation parameters does not always relieve dyspnea, and administering morphine prolongs the duration of mechanical ventilation. The possibility of distracting the patients' attention or modulating their emotions in order to relieve their dyspnea seems to be a simple way to improve their comfort and could represent an innovative therapeutic alternative.
In this context, the investigators hypothesize that pleasant extra respiratory sensory stimulation relieves dyspnea in artificially ventilated patients without any change in ventilator settings and pharmacological intervention.
The main objective of our study is to demonstrate, in dyspneic patients undergoing artificial ventilation, a decrease in dyspnea under the effect of :
- listening to a piece of music versus pink noise;
- the application of cold air to the face versus the application of cold air to the calf.
The secondary objectives are to evaluate the effect of extra-respiratory stimuli on :
- the quality of dyspnea (thirst for air, excessive respiratory work, concentration)
- the intensity of secondary emotional responses (anxiety, fear).
- the electromyographic activity of extra-diaphragmatic inspiratory muscles
STUDY CONDITIONS The experimental sessions will take place in the patient's room, in the Intensive Care Unit of Prof. T. Similowski.
Patients will have been previously informed orally and in writing and will have signed the informed consent.
TYPE OF STUDY It is research involving the human person with minimal risk and constraints, interventional, open, randomized.
POPULATION, SAMPLING All subjects, without exception, must understand French and have read and understood the appropriate information leaflet and signed the consent form.
It is research involving the human person with minimal risk and constraints, interventional, open, randomized.
PATIENT MONITORING During the experimental sessions, an investigating physician will systematically be present in the room. Any tolerance abnormality (agitation, disturbance of vigilance, SpO2 <88%, tachycardia greater than 130/min or mean blood pressure < 60mmHG) will lead to the interruption of the experimental session.
EXPERIMENTAL PROTOCOL Each patient will participate in a single one-hour experimental session that will take place as follows.
The type of stimulation administered to the patient will be determined by randomization. The order of administration of the stimulation and its control will also be determined by randomization.
Each experimental session will consist of ten sequences of 10 minutes each.
The experimental sequences will proceed as follows:
BASIC: recording of ventilation parameters, constants, ECG, skin conductance and psycho-sensory parameters at baseline.
PRESSURE SUPPORT INCREMENT: An pressure support (+5) increment will be performed to ensure comparability of subsequent experimental sequences and their effect on dyspnea.
WASH OUT: new recording in basic ventilation. Sensory and psycho-sensory parameters are again collected as above.
STIMULUS 1 case or control: administration of extra-respiratory stimulation 1 or its control depending on the randomization arm. Sensory and psycho-sensory variables are measured as above.
WASH OUT: new recording in basic ventilation. Sensory and psycho-sensory parameters are again collected as above.
STIMULUS 1 case or control: administration of extra-respiratory stimulation 1 or its control according to the randomization arm. Sensory and psycho-sensory variables are measured as above.
WASH OUT: new recording in basic ventilation. Sensory and psycho-sensory parameters are again collected as above.
STIMULUS 2 cases or control: administration of extra respiratory stimulation 1 or its control according to the randomization arm. Sensory and psycho-sensory variables are measured as above.
WASH OUT: new recording in basic ventilation. Sensory and psycho-sensory parameters are again collected as above.
STIMULUS 2 cases or control: administration of extra respiratory stimulation 1 or its control according to the randomization arm. Sensory and psycho-sensory variables are measured as above.
RECOVERY: Interruption of the stimulation or its control is interrupted. Recording of ventilatory, sensory and psycho-sensory parameters after return to baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Basal | Active comparator | Other: Auditory control, Other: Sensitive controlThe impact of these stimulations will be compared to that of a control stimulus. The auditory control condition will consist of listening to a pink noise. The pink noise, like the white noise, is a normalized noise. The sound produced on a TV set that is out of adjustment during the "snow effect" is a representative example of such noise. Pink noise is a random signal whose power spectral density decreases by 3dB per octave. This signal is closer to the sensitivity of the ear than white noise. The sensitive control condition will be achieved by administering fresh air on the calf. An pressure support (+5) increment will be performed to ensure comparability of subsequent experimental sequences and their effect on dyspnea. |
| Intervention | Experimental | Other: Auditive stimulation, Other: Sensitive stimulationPatients will be subjected to sensory stimuli that may be auditory or sensitive. The sensory stimulations will be administered by a research nurse. The auditory stimulation will consist of listening to relaxing pieces of music from MP3 files from the International Center for Music Therapy (Noisy le Grand, France). Listening will be done through noise-cancelling headphones (PLANTRONICS, Gamecom 780, Santa Cruz, California, USA) for 10 minutes. Sensitive stimulation will consist of administering fresh air to the patient's face by means of a fan without blades (DYSON AM01, Malmesbury, UK) for 10 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Mechanical ventilation : invasive for at least 48 hours or non-invasive for at least 24 hours, sequential or continuous
- Dyspnea ≥ 4 on a visual analogic scale (VAS) from 0 to 10
- Absence of delirium (evaluated by the CAM-ICU score) ;
- Communicative patient
Key exclusion criteria (5 listed)
- Patients on ECMO or decarboxylation ;
- Patients on long-term left ventricular support;
- Patients postoperatively following any surgery (pain from the procedure may interfere with dyspnea);
- Protected minors and adults;
- Pregnant women.
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 |
|---|---|---|
| Auditive stimulationThe auditory stimulation will consist of listening to relaxing pieces of music from MP3 files from the International Center for Music Therapy (Noisy le Grand, France). Listening will be done through noise-cancelling headphones (PLANTRONICS, Gamecom 780, Santa Cruz, California, USA) for 10 minutes. | Other | Intervention |
| Sensitive stimulationSensitive stimulation will consist of administering fresh air to the patient's face by means of a fan without blades (DYSON AM01, Malmesbury, UK) for 10 minutes. | Other | Intervention |
| Auditory controlThe auditory control condition will consist of listening to a pink noise. The pink noise, like the white noise, is a normalized noise. The sound produced on a TV set that is out of adjustment during the "snow effect" is a representative example of such noise. Pink noise is a random signal whose power spectral density decreases by 3dB per octave. This signal is closer to the sensitivity of the ear than white noise. | Other | Basal |
| Sensitive controlThe sensitive control condition will be achieved by administering fresh air on the calf. | Other | Basal |
Primary outcome
Detection and quantification of dyspnea intensity change
Time frame: At the baseline and during the interventions
Dyspnea will initially be searched for with absence or presence. If present, it will then be quantified using a visual analog scale graduated from 0 ("absence of respiratory discomfort") to 10 ("maximum respiratory discomfort").
3 secondary outcomes
Anxiety
Time frame: At the baseline and during the interventions
Mesure of pain
Time frame: At the baseline and during the interventions
Electromyogram of extra-diaphragmatic inspiratory muscles
Time frame: At the baseline and during the interventions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2022.
- Background: PubMed 22336677Parshall MB, Schwartzstein RM, Adams L, Banzett RB, Manning HL, Bourbeau J, Calverley PM, Gift AG, Harver A, Lareau SC, Mahler DA, Meek PM, O'Donnell DE; American Thoracic Society Committee on Dyspnea. An official American Thoracic Society statement: update on the mechanisms, assessment, and management of dyspnea. Am J Respir Crit Care Med. 2012 Feb 15;185(4):435-52. doi: 10.1164/rccm.201111-2042ST.
- Background: PubMed 16870842Morelot-Panzini C, Demoule A, Straus C, Zelter M, Derenne JP, Willer JC, Similowski T. Dyspnea as a noxious sensation: inspiratory threshold loading may trigger diffuse noxious inhibitory controls in humans. J Neurophysiol. 2007 Feb;97(2):1396-404. doi: 10.1152/jn.00116.2006. Epub 2006 Jul 26.
- Background: PubMed 21572329Schmidt M, Demoule A, Polito A, Porchet R, Aboab J, Siami S, Morelot-Panzini C, Similowski T, Sharshar T. Dyspnea in mechanically ventilated critically ill patients. Crit Care Med. 2011 Sep;39(9):2059-65. doi: 10.1097/CCM.0b013e31821e8779.
- Background: PubMed 12958109Abernethy AP, Currow DC, Frith P, Fazekas BS, McHugh A, Bui C. Randomised, double blind, placebo controlled crossover trial of sustained release morphine for the management of refractory dyspnoea. BMJ. 2003 Sep 6;327(7414):523-8. doi: 10.1136/bmj.327.7414.523.
- Background: PubMed 18706531Lansing RW, Gracely RH, Banzett RB. The multiple dimensions of dyspnea: review and hypotheses. Respir Physiol Neurobiol. 2009 May 30;167(1):53-60. doi: 10.1016/j.resp.2008.07.012. Epub 2008 Jul 25.
- Derived from this study: PubMed 37678956Bureau C, Nierat MC, Decavele M, Rivals I, Dangers L, Beurton A, Virolle S, Deleris R, Delemazure J, Mayaux J, Morelot-Panzini C, Dres M, Similowski T, Demoule A. Sensory interventions to relieve dyspnoea in critically ill mechanically ventilated patients. Eur Respir J. 2024 Jan 18;63(1):2202215. doi: 10.1183/13993003.02215-2022. Print 2024 Jan.
- 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.
Alexandre DEMOULE, MD, PhD principal investigator
Groupe Hospitalier Universitaire APHP - Sorbonne Université Site Pitié-Salpêtrière (bâtiment Eole)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auditive stimulation and Sensitive stimulation in people with Dyspnea, run by Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 2 Sep 2022. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Detection and quantification of dyspnea intensity change (time frame: At the baseline and during the interventions). 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 NCT04815317, which also lists 6 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 2 Sep 2022.