Comparing cardiac variability in sleep apnea and healthy individuals
Evaluation of Autonomic Activity in REM Sleep by a New Marker of Cardiac Variability in Subjects With Severe Obstructive Sleep Apnea Hypopnea Syndrome
University Hospital, Lille · NCT06808464
This study is testing how heart rate changes during sleep in people with severe sleep apnea compared to healthy individuals to see if it can help create a better way to screen for sleep apnea.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 97 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Sponsor | University Hospital, Lille (other) |
| Locations | 1 site (Lille) |
| Trial ID | NCT06808464 on ClinicalTrials.gov |
What this trial studies
This observational study aims to analyze cardiac variability in patients with severe sleep apnea syndrome (SAS) compared to healthy individuals. The research focuses on measuring variations in cardiac variability during REM sleep, a critical phase for sleep apnea risk. By employing a machine learning system, the study seeks to establish a reliable and accessible screening method for SAS in outpatient settings. The methodology will also extend to other sleep phases and correlate findings with established cardiac variability markers.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with severe sleep apnea syndrome and healthy subjects without sleep disorders.
Not a fit: Patients with cardiac rhythm disorders or other significant neurological or psychiatric conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved screening methods for sleep apnea, making diagnosis more accessible and efficient.
How similar studies have performed: While similar approaches using cardiac variability and machine learning have been explored, this specific methodology in the context of sleep apnea is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Lille
- Service de Neurophysiologie - unité de médecine du Sommeil - CHU Lille — Lille, France (RECRUITING)
Study contacts
- Principal investigator: Philippe DERAMBURE, MD — University Hospital, Lille
- Study coordinator: Philippe DERAMBURE, PR
- Email: Philippe.DERAMBURE@chu-lille.fr
- Phone: 0320445962
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Sleep Apnea, Sleep apnea hypopnea syndrome, Autonomic nervous system, Cardiac variability, Automatic detection, Machine Learning