NCT06808464 New Approach in the Study of the Autonomic Nervous System Through Cardiac Variability in Sleep Apnea Syndrome.
| NCT ID | NCT06808464 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Lille |
| Condition | Sleep Apnea |
| Study Type | OBSERVATIONAL |
| Enrollment | 97 participants |
| Start Date | 2025-05-14 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 97 participants in total. It began in 2025-05-14 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: 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 * 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
Contact & Investigator
Philippe DERAMBURE, MD
PRINCIPAL INVESTIGATOR
University Hospital, Lille
Frequently Asked Questions
Who can join the NCT06808464 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 64 Years, studying Sleep Apnea. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06808464 currently recruiting?
Yes, NCT06808464 is actively recruiting participants. Contact the research team at Philippe.DERAMBURE@chu-lille.fr for enrollment information.
Where is the NCT06808464 trial being conducted?
This trial is being conducted at Lille, France.
Who is sponsoring the NCT06808464 clinical trial?
NCT06808464 is sponsored by University Hospital, Lille. The principal investigator is Philippe DERAMBURE, MD at University Hospital, Lille. The trial plans to enroll 97 participants.