Obstructive Sleep Apnea Clinical Trials

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Evaluation of Autonomic Activity in REM Sleep by a New Marker of Cardiac Variability in Subjects With Severe Obstructive Sleep Apnea Hypopnea Syndrome

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 64
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
France
Service de Neurophysiologie - unité de médecine du Sommeil - CHU Lille
RECRUITING
Lille
Contact Information
Primary
Philippe DERAMBURE, PR
Philippe.DERAMBURE@chu-lille.fr
0320445962
Time Frame
Start Date: 2025-05-14
Estimated Completion Date: 2027-02
Participants
Target number of participants: 97
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Lille

This content was sourced from clinicaltrials.gov