New Approach in the Study of the Autonomic Nervous System Through Cardiac Variability in Sleep Apnea Syndrome.

Sponsor
University Hospital, Lille
Study ID
NCT06808464
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Accepted

Study Details

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

Key Dates

First listed
Feb 5, 2025
Start date
May 14, 2025
Status verified
May 2025
Primary completion
Feb 28, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
97 participants (estimated)

Arms

  • Arm: Experimental group
    Arm "experimental" consists in questioners and polysomnography on patients with severe sleep apnea
  • Arm: Control group
    Arm "control" consists in questioners and polysomnography on healthy subjects

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 ) ]

Central Contacts

Related Studies