Actively Recruiting
New Approach in the Study of the Autonomic Nervous System Through Cardiac Variability in Sleep Apnea Syndrome.
Led by University Hospital, Lille · Updated on 2025-05-29
97
Participants Needed
1
Research Sites
89 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
New Approach in the Study of the Autonomic Nervous System Through Cardiac Variability in Sleep Apnea Syndrome.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy subjects must have no sleep disorder as referenced in the ICSD-3.
- Healthy subjects must have an Epworth Sleep Scale score less than 11.
- Healthy subjects must have a Pittsburgh Quality Sleep Index score less than 6.
- Healthy subjects must have fewer than 2 positive categories on the Berlin Questionnaire.
- Healthy subjects must have a STOP BANG score less than 3.
- Healthy subjects must have a normal HADS score.
- Healthy subjects must not have restless legs syndrome (RLS).
- Subjects with severe SAS must have an apnea-hypopnea index (AHI) greater than 30 per hour obstructive.
- Participants must be between 18 and 64 years old.
You will not qualify if you...
- Participants with cardiac rhythm disorders are excluded.
- Participants with neurological or psychiatric pathology affecting the autonomic nervous system are excluded.
- Healthy subjects with complaints or known sleep disorders are excluded.
- Healthy subjects with sleep pathology detected by polysomnography are excluded.
- Healthy subjects with total sleep time less than 4 hours during polysomnography are excluded.
- Healthy subjects with technically unusable recordings are excluded.
- Subjects with severe SAS and associated sleep pathology at diagnosis are excluded.
- Participants unable to receive informed information or unable to participate in the entire study are excluded.
- Participants without social security coverage are excluded.
- Participants who refuse to sign consent are excluded.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Service de Neurophysiologie - unité de médecine du Sommeil - CHU Lille
Lille, France
Actively Recruiting
Research Team
P
Philippe DERAMBURE, PR
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here