Sleep ApneaHRVSASNCT06808464
New Approach in the Study of the Autonomic Nervous System Through Cardiac Variability in Sleep Apnea Syndrome.
An observational study of Sleep Apnea, run by University Hospital, Lille at 1 site in France.
Trial summary
The main objective of this study is to compare the different variations of the cardiac variability index measured thanks to the technique developed by the CIC-IT between subjects with severe SAS and healthy subjects with sleep pathology. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea
- How many people
- 97 participants
- Where
- 1 siteFrance
- Study dates
- 14 May 2025to Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Recruitment of patients after the diagnosis of severe SAS in the services of the University Hospital of Lille. The healthy subjects will be recruited through an advertisement in the general medicine networks of the Hauts de France region.
Who may be able to join
- Group healthy subjects - 1): absence of sleep disorder referenced in the ICSD-3.
- Epworth Sleep Scale < 11
- Pittsburgh Quality Sleep Index < 6
- Berlin Questionnaire: < 2 positive categories
- STOP BANG <3
- HADS normal
- No RLS
- Group 2 (subjects with severe SAS - 2): AHI > 30/h obstructive
Who cannot join
- Non-inclusion criteria:
- Cardiac rhythm disorder
- Neurological or psychiatric pathology impacting on ANS
- Control group (healthy subjects - 1)
- Complaint of sleep disorder
- Known sleep disorder
Show all 17Show fewer
- Experimental group (subjects with severe SAS - 2):
- o Associated sleep pathology at diagnosis of severe SAS
- Administrative reasons:
- Unable to receive informed information,
- Unable to participate in the entire study
- Lack of social security coverage
- Refusal to sign consent Exclusion criteria
- Control group (healthy subjects - 1):
- Sleep pathology detected by polysomnography
- Total sleep time less than 4 hours
- Recording technically not usable
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service de Neurophysiologie - unité de médecine du Sommeil - CHU Lille
Lille
Philippe Derambure, Pr, philippe.derambure@chu-lille.fr
About this study
Official title: Evaluation of Autonomic Activity in REM Sleep by a New Marker of Cardiac Variability in Subjects With Severe Obstructive Sleep Apnea Hypopnea Syndrome
The main objective of this study is to compare the different variations of the cardiac variability index measured thanks to the technique developed by the CIC-IT between subjects with severe SAS and healthy subjects with sleep pathology.
In a first step, these two groups will be compared in REM sleep phase because it is the period during which the risk of sleep apnea syndrome is the highest. In a second step, the same methodology will be applied for the other sleep phases and correlations will be established with the other markers of cardiac variability (HRV) already known. This will allow to validate a reliable method of screening for SAS that is more accessible in ambulatory settings by means of a machine learning system based on artificial intelligence
- Conditions
- Sleep Apnea
- Keywords
- Sleep apnea hypopnea syndrome, Autonomic nervous system, Cardiac variability, Automatic detection, Machine Learning
- Medical subject headings
- Sleep Apnea Syndromes, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Arm "experimental" consists in questioners and polysomnography on patients with severe sleep apnea | |
| Control group | Arm "control" consists in questioners and polysomnography on healthy subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability of the high frequency variability index (HFVI) measured in REM sleep phase to differentiate subjects with severe SAS and healthy subjects with sleep pathology
Measured: Baseline (The day of the polysomnography )
Secondary outcomes (3)
Mean value of the IVHF in the other sleep stages (N1, N2 and N3)
Variations of the IVHF between subjects with severe SAS and healthy subjects for the other sleep stages
Measured: Baseline (The day of the polysomnography )
Mean value of other VFC variables in the different sleep stages (REM, N1, N2 and N3)
Variations of the other markers of cardiac variability between subjects with severe SAS and healthy subjects for all sleep phases
Measured: Baseline (The day of the polysomnography )
Total score and sub-score of the SCOPA-AUT questionnaire (between 0-69), with the possibility of analysis of the different sub-scores.
Variation of other nervous system components by standardized questionnaire between a group with severe SAS and a group of control subjects
Measured: Baseline (The day of the polysomnography )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start14 May 2025
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 97 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe DERAMBURE, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06808464
- Sponsor's protocol ID
- 2021_0403
- Other IDs
- 2022-A01069-34
- Acronym
- HRVSAS
- Status last verified
- May 2025
- First submitted
- 29 Jan 2025
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Autonomic Activity in REM Sleep by a New Marker of Cardiac Variability in Subjects With Severe Obstructive Sleep Apnea Hypopnea Syndrome
- ClinicalTrials.gov ID
- NCT06808464
- Acronym / sponsor ID
- HRVSAS / 2021_0403
- Conditions
- Sleep Apnea
- Keywords
- Sleep apnea hypopnea syndrome, Autonomic nervous system, Cardiac variability, Automatic detection, Machine Learning
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 97 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 14 May 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 5 Feb 2025 (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 main objective of this study is to compare the different variations of the cardiac variability index measured thanks to the technique developed by the CIC-IT between subjects with severe SAS and healthy subjects with sleep pathology.
In a first step, these two groups will be compared in REM sleep phase because it is the period during which the risk of sleep apnea syndrome is the highest. In a second step, the same methodology will be applied for the other sleep phases and correlations will be established with the other markers of cardiac variability (HRV) already known. This will allow to validate a reliable method of screening for SAS that is more accessible in ambulatory settings by means of a machine learning system based on artificial intelligence
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | – | –Arm "experimental" consists in questioners and polysomnography on patients with severe sleep apnea |
| Control group | – | –Arm "control" consists in questioners and polysomnography on healthy subjects |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Recruitment of patients after the diagnosis of severe SAS in the services of the University Hospital of Lille. The healthy subjects will be recruited through an advertisement in the general medicine networks of the Hauts de France region.
Key inclusion criteria (8 listed)
- Group healthy subjects - 1): absence of sleep disorder referenced in the ICSD-3.
- Group 2 (subjects with severe SAS - 2): AHI > 30/h obstructive
Key exclusion criteria (17 listed)
- Cardiac rhythm disorder
- Neurological or psychiatric pathology impacting on ANS
- Control group (healthy subjects - 1)
- Experimental group (subjects with severe SAS - 2):
- o Associated sleep pathology at diagnosis of severe SAS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ability of the high frequency variability index (HFVI) measured in REM sleep phase to differentiate subjects with severe SAS and healthy subjects with sleep pathology
Time frame: Baseline (The day of the polysomnography )
3 secondary outcomes
Mean value of the IVHF in the other sleep stages (N1, N2 and N3)
Time frame: Baseline (The day of the polysomnography )
Mean value of other VFC variables in the different sleep stages (REM, N1, N2 and N3)
Time frame: Baseline (The day of the polysomnography )
Total score and sub-score of the SCOPA-AUT questionnaire (between 0-69), with the possibility of analysis of the different sub-scores.
Time frame: Baseline (The day of the polysomnography )
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
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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.
Philippe DERAMBURE, MD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea, run by University Hospital, Lille 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 8 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 29 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Philippe DERAMBURE, PR (0320445962, Philippe.DERAMBURE@chu-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability of the high frequency variability index (HFVI) measured in REM sleep phase to differentiate subjects with severe SAS and healthy subjects with sleep pathology (time frame: Baseline (The day of the polysomnography )). 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 29 May 2025; AzTrials last refreshed its copy on 7 Nov 2026.