Autonomic Nervous SystemNCT05084313
Acute Effects of Deep-Slow Breathing Exercise and Cranial-Visceral Manual Therapy on ANS Parameters in Healthy Adults
A study testing Manual Therapy and Deep-slow breathing in people with Autonomic Nervous System, run by Ege University at 2 sites in Turkey (Türkiye).
Trial summary
The purpose of this study is to evaluate the effects of several manual therapy techniques on autonomic nervous system and to compare it with other groups in the study such as deep-slow breathing group and the control group. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Autonomic Nervous System
- What is being tested?
- Manual Therapy and Deep-slow breathing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Nov 2021to 1 Jun 2022
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- To be between 18- 30 years old.
- To volunteer to participate in the study
- Not engaging in regular exercise.
- Not to have a chronical disease or history of chronical disease.
- Not to take any medication that affects heart rate variability.
Who cannot join
- Being outside of the range of 18- 30 years old.
- To have any kind of medical condition that disturbs the autonomic nervous system
- To have a chronical disease
- To have a regular medication
- To have/had head injury, intracranial bleeding or increased intracranial pressure.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Ege University Research Hospital- Dpt. of Exercise and Sports Medicine
Izmir, 35100
Ege University Research Hospital
Izmir, 35100
About this study
The purpose of this study is to evaluate the effects of several manual therapy techniques on autonomic nervous system and to compare it with other groups in the study such as deep-slow breathing group and the control group. The measurements will take place right before and after the intervention to evaluate the effects of one single intervention.
Read the detailed description
All the patients will be clearly informed and will be included in the present study after their informed consent. The autonomic nervous system (ANS) will be evaluated using bio-sensors such as Photoplethysmography (PPG) and Galvanic skin response (GSR). The measurements will take place once for an individual. There will be three groups consisted of manual therapy, deep-slow breathing, and control groups. Non-invasive cranial and visceral techniques will be applied on the manual therapy group. The deep-slow breathing group will get an intervention consisting of deep-paced breathing to increase cardiac harmony. The control group will rest for the same amount of time as other interventions to distinguish whether the changes are related to intervention. After given consent, the participant will be assigned randomly to one of three groups. All the participants will be subjected to baseline measurement of the abovementioned metrics prior to intervention. All the interventions will take place in a controlled setting. After baseline measurement, the participant will take one of the three interventions which will take 30 minutes. After the data for each person is captured via sensors, it will be stored on a personal computer for further analysis and interpretation.
According to investigator's hypothesis, deep-slow breathing group will show signs of sympathetic withdrawal and parasympathetic dominance and that manual therapy group will also show same autonomic shift too.
- Conditions
- Autonomic Nervous System
- Being tested
- Manual Therapy, Deep-slow breathing, Control
- Keywords
- Deep-slow breathing, manual therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual TherapyOther
This group of patients will receive manual therapy techniques to harmonize vegetative nervous system. PPG and GSR will be recorded during the intervention. The techniques consist of CV-4 technique, suboccipital decompression, lumbo-sacral decompression, release of the transverse diaphragms, frontal lift technique, parietal lift technique, temporal techniques, temporo-mandibular joint myofascial release, deep cervical fasciae technique as described in Upledger's protocol. In addition to the protocol; rib raising technique, larynx and sternocleidomastoid muscle fascial release and occipito-mastoid suture release will be applied. All intervention is planned to take approximately 20 minutes. The group will include forty healthy individuals.
Deep-slow breathingOther
Patients in this group will do slow paced breathing to increase heart rate variability as it can be partially modulated by respiratory effects. The patients will be able to cease the session in case of feeling uncomfortable. The main purpose will be that the individuals should breathe six breaths per minute to increase respiratory sinus arrhythmia which is also reflected at PPG waveforms and in reduction in GSR. The group will include forty healthy individuals.
ControlOther
Control group patients will be attached to the sensors, and they will rest in a quiet and controlled indoor environment without any intervention. The aim of including this group is to to understand whether the parasympathetic effects expected in the manual therapy group were due to the intervention. The group will include forty healthy individuals.
| Study group | Role | What they receive |
|---|---|---|
| Manual therapy group | Experimental | This group of patients will receive manual therapy techniques to harmonize vegetative nervous system. PPG and GSR will be recorded during the intervention. The techniques consist of CV-4 technique, suboccipital decompression, lumbo-sacral decompression, release of the transverse diaphragms, frontal lift technique, parietal lift technique, temporal techniques, temporo-mandibular joint myofascial release, deep cervical fasciae technique as described in Upledger's protocol. In addition to the protocol; rib raising technique, larynx and sternocleidomastoid muscle fascial release and occipito-mastoid suture release will be applied. All intervention is planned to take approximately 20 minutes. The group will include 40 healthy individuals. Receives: Other: Manual Therapy |
| Deep-slow breathing group | Active comparator | Patients in this group will do deep-slow paced breathing exercise. The patients will be able to cease the session in case of feeling uncomfortable. The main purpose will be that the individuals should breathe six breaths per minute to increase respiratory sinus arrhythmia which is also reflected at PPG waveforms and in reduction in GSR. The group will include forty healthy individuals. Receives: Other: Deep-slow breathing |
| Control | Other | Control group patients will be attached to the sensors, and they will rest in a quiet and controlled indoor environment without any intervention. The aim of including this group is to to understand whether the parasympathetic effects expected in the manual therapy group were due to the intervention. The group will include forty healthy individuals. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Inter-beat interval (IBI)
Inter-beat interval is the recorded physiological parameter and defined as the time interval between consecutive R wave peaks in milliseconds which will be obtained via photoplethysmography device and the relevant further analysis will be carried on in a software which was shown to be valid and reliable in a clinical research setting.
Measured: Average of 5 minutes of measurement as a pre-intervention baseline value as time point zero. Average of intervention time as time point one and average of 5 min epoch right after the intervention as time point two.
Change in Standard deviation of Normal-to-Normal intervals (SDNN)
The standard deviation of Normal-to-Normal IBI of normal sinus beats in milliseconds.
Measured: Average of 5 minutes of measurement as a pre-intervention baseline value as time point zero. Average of 20 minutes (intervention) as time point one and average of 5 min epoch right after the intervention as time point two.
Change in pNN50 (The percentage of adjacent Normal-to-Normal intervals that differ from each other by more than 50 ms as percentage )
The percentage of adjacent Normal-to-Normal intervals that differ from each other by more than 50 ms as percentage (%).
Measured: Average of 5 minutes of measurement as a pre-intervention baseline value as time point zero. Average of 20 minutes (intervention) as time point one and average of 5 min epoch right after the intervention as time point two.
Change in RMSSD
The root mean square of successive differences between normal (sinus) heartbeats in milliseconds.
Measured: Average of 5 minutes of measurement as a pre-intervention baseline value as time point zero. Average of 20 minutes (intervention) as time point one and average of 5 min epoch right after the intervention as time point two.
Change in Total power
Total power is the sum of the energy in the Low Frequency and High Frequency bands' spectral power for short-term recordings in units of ms2.
Measured: Average of 5 minutes of measurement as a pre-intervention baseline value as time point zero. Average of 20 minutes (intervention) as time point one and average of 5 min epoch right after the intervention as time point two.
Change in HF band power and LF band power
Spectral analysis of High Frequency band (Absolute power of the high-frequency band (0.15-0.4 Hz)) reflects parasympathetic activity and Spectral analysis Low Frequency band Absolute power of the low-frequency band (0.04-0.15 Hz)reflects baroreflex activity.These parameters will be calculated both as absolute (ms2) and relative units. Relative power is estimated as the percentage of total Heart Rate Variability (HRV) power or in normal units (nu), which divides the absolute power for a specific frequency band by the summed absolute power of the LF and HF bands in normalised units (nu).
Measured: Average of 5 minutes of measurement as a pre-intervention baseline value as time point zero. Average of 20 minutes (intervention) as time point one and average of 5 min epoch right after the intervention as time point two.
LF/HF Ratio
may estimate the ratio between sympathetic nervous system (SNS) and parasympathetic nervous system (PNS) activity under controlled conditions in units of ms2.
Measured: Average of 5 minutes of measurement as a pre-intervention baseline value as time point zero. Average of 20 minutes (intervention) as time point one and average of 5 min epoch right after the intervention as time point two.
Galvanic Skin Response
Electrical conductance between two electrodes attached on 2 fingers of the individual in units of micro-Siemens (μS).
Measured: Average of 5 minutes of measurement as a pre-intervention baseline value as time point zero. Average of 20 minutes (intervention) as time point one and average of 5 min epoch right after the intervention as time point two.
SD1
SD1 is one of the non-linear HRV measure and defined as Poincaré plot standard deviation perpendicular the line of identity. It measures short-term Heart Rate Variability in milliseconds and correlates with baroreflex sensitivity (BRS), which is the change in IBI duration per unit change in BP, and HF (high frequency) power.
Measured: Average of 5 minutes of measurement as a pre-intervention baseline value as time point zero. Average of 20 minutes (intervention) as time point one and average of 5 min epoch right after the intervention as time point two.
SD2
SD2 is one of the non-linear HRV measure and defined as Poincaré plot standard deviation along the line of identity. It measures short- and long-term HRV in milliseconds and correlates with LF power and baroreflex sensitivity (BRS).
Measured: Average of 5 minutes of measurement as a pre-intervention baseline value as time point zero. Average of 20 minutes (intervention) as time point one and average of 5 min epoch right after the intervention as time point two.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start1 Nov 2021
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autonomic Nervous SystemStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are three groups in the study, two of which includes interventions, and one group constitutes the control group. The participants will be randomized into groups with a sealed envelope. There is only one session of the allocated intervention for the particular participant, since the study aims to measure acute effects of cranial and visceral manual therapy on autonomic nervous system parameters.
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ihsan Yoruk, Ege University
- Investigators
- ihsan yoruk, MD, Principal investigator, Ege University Research Hospital- Dpt. of Exercise and Sports Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05084313
- Sponsor's protocol ID
- TTU-2021-22675
- Status last verified
- Jun 2022
- First submitted
- 18 Sep 2021
- Last updated
- 15 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Deep-Slow Breathing Exercise and Cranial-Visceral Manual Therapy on ANS Parameters in Healthy Adults
- ClinicalTrials.gov ID
- NCT05084313
- Acronym / sponsor ID
- TTU-2021-22675
- Conditions
- Autonomic Nervous System
- Keywords
- Deep-slow breathing, manual therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 19 Oct 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.
The purpose of this study is to evaluate the effects of several manual therapy techniques on autonomic nervous system and to compare it with other groups in the study such as deep-slow breathing group and the control group. The measurements will take place right before and after the intervention to evaluate the effects of one single intervention.
Detailed description
All the patients will be clearly informed and will be included in the present study after their informed consent. The autonomic nervous system (ANS) will be evaluated using bio-sensors such as Photoplethysmography (PPG) and Galvanic skin response (GSR). The measurements will take place once for an individual. There will be three groups consisted of manual therapy, deep-slow breathing, and control groups. Non-invasive cranial and visceral techniques will be applied on the manual therapy group. The deep-slow breathing group will get an intervention consisting of deep-paced breathing to increase cardiac harmony. The control group will rest for the same amount of time as other interventions to distinguish whether the changes are related to intervention. After given consent, the participant will be assigned randomly to one of three groups. All the participants will be subjected to baseline measurement of the abovementioned metrics prior to intervention. All the interventions will take place in a controlled setting. After baseline measurement, the participant will take one of the three interventions which will take 30 minutes. After the data for each person is captured via sensors, it will be stored on a personal computer for further analysis and interpretation.
According to investigator's hypothesis, deep-slow breathing group will show signs of sympathetic withdrawal and parasympathetic dominance and that manual therapy group will also show same autonomic shift too.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- There are three groups in the study, two of which includes interventions, and one group constitutes the control group. The participants will be randomized into groups with a sealed envelope. There is only one session of the allocated intervention for the particular participant, since the study aims to measure acute effects of cranial and visceral manual therapy on autonomic nervous system parameters.
| Arm | Type | Receives |
|---|---|---|
| Manual therapy group | Experimental | Other: Manual TherapyThis group of patients will receive manual therapy techniques to harmonize vegetative nervous system. PPG and GSR will be recorded during the intervention. The techniques consist of CV-4 technique, suboccipital decompression, lumbo-sacral decompression, release of the transverse diaphragms, frontal lift technique, parietal lift technique, temporal techniques, temporo-mandibular joint myofascial release, deep cervical fasciae technique as described in Upledger's protocol. In addition to the protocol; rib raising technique, larynx and sternocleidomastoid muscle fascial release and occipito-mastoid suture release will be applied. All intervention is planned to take approximately 20 minutes. The group will include 40 healthy individuals. |
| Deep-slow breathing group | Active comparator | Other: Deep-slow breathingPatients in this group will do deep-slow paced breathing exercise. The patients will be able to cease the session in case of feeling uncomfortable. The main purpose will be that the individuals should breathe six breaths per minute to increase respiratory sinus arrhythmia which is also reflected at PPG waveforms and in reduction in GSR. The group will include forty healthy individuals. |
| Control | Other | Other: ControlControl group patients will be attached to the sensors, and they will rest in a quiet and controlled indoor environment without any intervention. The aim of including this group is to to understand whether the parasympathetic effects expected in the manual therapy group were due to the intervention. The group will include forty healthy individuals. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- To be between 18- 30 years old.
- To volunteer to participate in the study
- Not engaging in regular exercise.
- Not to have a chronical disease or history of chronical disease.
- Not to take any medication that affects heart rate variability.
Key exclusion criteria (5 listed)
- Being outside of the range of 18- 30 years old.
- To have any kind of medical condition that disturbs the autonomic nervous system
- To have a chronical disease
- To have a regular medication
- To have/had head injury, intracranial bleeding or increased intracranial pressure.
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 |
|---|---|---|
| Manual TherapyThis group of patients will receive manual therapy techniques to harmonize vegetative nervous system. PPG and GSR will be recorded during the intervention. The techniques consist of CV-4 technique, suboccipital decompression, lumbo-sacral decompression, release of the transverse diaphragms, frontal lift technique, parietal lift technique, temporal techniques, temporo-mandibular joint myofascial release, deep cervical fasciae technique as described in Upledger's protocol. In addition to the protocol; rib raising technique, larynx and sternocleidomastoid muscle fascial release and occipito-mastoid suture release will be applied. All intervention is planned to take approximately 20 minutes. The group will include forty healthy individuals. | Other | Manual therapy group |
| Deep-slow breathingPatients in this group will do slow paced breathing to increase heart rate variability as it can be partially modulated by respiratory effects. The patients will be able to cease the session in case of feeling uncomfortable. The main purpose will be that the individuals should breathe six breaths per minute to increase respiratory sinus arrhythmia which is also reflected at PPG waveforms and in reduction in GSR. The group will include forty healthy individuals. | Other | Deep-slow breathing group |
| ControlControl group patients will be attached to the sensors, and they will rest in a quiet and controlled indoor environment without any intervention. The aim of including this group is to to understand whether the parasympathetic effects expected in the manual therapy group were due to the intervention. The group will include forty healthy individuals. | Other | Control |
Primary outcome
Change in Inter-beat interval (IBI)
Time frame: Average of 5 minutes of measurement as a pre-intervention baseline value as time point zero. Average of intervention time as time point one and average of 5 min epoch right after the intervention as time point two.
Inter-beat interval is the recorded physiological parameter and defined as the time interval between consecutive R wave peaks in milliseconds which will be obtained via photoplethysmography device and the relevant further analysis will be carried on in a software which was shown to be valid and reliable in a clinical research setting.
Change in Standard deviation of Normal-to-Normal intervals (SDNN)
Time frame: Average of 5 minutes of measurement as a pre-intervention baseline value as time point zero. Average of 20 minutes (intervention) as time point one and average of 5 min epoch right after the intervention as time point two.
The standard deviation of Normal-to-Normal IBI of normal sinus beats in milliseconds.
Change in pNN50 (The percentage of adjacent Normal-to-Normal intervals that differ from each other by more than 50 ms as percentage )
Time frame: Average of 5 minutes of measurement as a pre-intervention baseline value as time point zero. Average of 20 minutes (intervention) as time point one and average of 5 min epoch right after the intervention as time point two.
The percentage of adjacent Normal-to-Normal intervals that differ from each other by more than 50 ms as percentage (%).
Change in RMSSD
Time frame: Average of 5 minutes of measurement as a pre-intervention baseline value as time point zero. Average of 20 minutes (intervention) as time point one and average of 5 min epoch right after the intervention as time point two.
The root mean square of successive differences between normal (sinus) heartbeats in milliseconds.
Change in Total power
Time frame: Average of 5 minutes of measurement as a pre-intervention baseline value as time point zero. Average of 20 minutes (intervention) as time point one and average of 5 min epoch right after the intervention as time point two.
Total power is the sum of the energy in the Low Frequency and High Frequency bands' spectral power for short-term recordings in units of ms2.
Change in HF band power and LF band power
Time frame: Average of 5 minutes of measurement as a pre-intervention baseline value as time point zero. Average of 20 minutes (intervention) as time point one and average of 5 min epoch right after the intervention as time point two.
Spectral analysis of High Frequency band (Absolute power of the high-frequency band (0.15-0.4 Hz)) reflects parasympathetic activity and Spectral analysis Low Frequency band Absolute power of the low-frequency band (0.04-0.15 Hz)reflects baroreflex activity.These parameters will be calculated both as absolute (ms2) and relative units. Relative power is estimated as the percentage of total Heart Rate Variability (HRV) power or in normal units (nu), which divides the absolute power for a specific frequency band by the summed absolute power of the LF and HF bands in normalised units (nu).
LF/HF Ratio
Time frame: Average of 5 minutes of measurement as a pre-intervention baseline value as time point zero. Average of 20 minutes (intervention) as time point one and average of 5 min epoch right after the intervention as time point two.
may estimate the ratio between sympathetic nervous system (SNS) and parasympathetic nervous system (PNS) activity under controlled conditions in units of ms2.
Galvanic Skin Response
Time frame: Average of 5 minutes of measurement as a pre-intervention baseline value as time point zero. Average of 20 minutes (intervention) as time point one and average of 5 min epoch right after the intervention as time point two.
Electrical conductance between two electrodes attached on 2 fingers of the individual in units of micro-Siemens (μS).
SD1
Time frame: Average of 5 minutes of measurement as a pre-intervention baseline value as time point zero. Average of 20 minutes (intervention) as time point one and average of 5 min epoch right after the intervention as time point two.
SD1 is one of the non-linear HRV measure and defined as Poincaré plot standard deviation perpendicular the line of identity. It measures short-term Heart Rate Variability in milliseconds and correlates with baroreflex sensitivity (BRS), which is the change in IBI duration per unit change in BP, and HF (high frequency) power.
SD2
Time frame: Average of 5 minutes of measurement as a pre-intervention baseline value as time point zero. Average of 20 minutes (intervention) as time point one and average of 5 min epoch right after the intervention as time point two.
SD2 is one of the non-linear HRV measure and defined as Poincaré plot standard deviation along the line of identity. It measures short- and long-term HRV in milliseconds and correlates with LF power and baroreflex sensitivity (BRS).
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 15 Jun 2022.
- Individual participant dataSharing planned: No
Related trials for Autonomic Nervous System
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Enrolling by invitationPhase 4
Low Dose Naltrexone Therapy for Complex Regional Pain Syndrome
Complex Regional Pain Syndrome, Chronic Pain
Active, not recruitingPhase 2
A Trial to Test if TEV-56286 is Effective for Treatment of Participants With Multiple System Atrophy
Multiple System Atrophy
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.
ihsan yoruk, MD principal investigator
Ege University Research Hospital- Dpt. of Exercise and Sports Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Therapy and Deep-slow breathing in people with Autonomic Nervous System, run by Ege University at 2 sites in Turkey (Türkiye).
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 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 15 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
Change in Inter-beat interval (IBI) (time frame: Average of 5 minutes of measurement as a pre-intervention baseline value as time point zero. Average of intervention time as time point one and average of 5 min epoch right after the intervention as time point two.). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jun 2022.