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

NCT06808464 — Recruiting, 97 participants, University Hospital, Lille

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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

Registry	NCT06808464, acronym HRVSAS
Status	Recruiting
Study type	Observational
Enrollment	97 (Estimated)
Sponsor	University Hospital, Lille (Other)
Conditions	Sleep Apnea
Dates	start 2025-05-14, primary completion 2027-02-01 (estimated), completion 2027-02-01 (estimated), first posted 2025-02-05, last updated 2025-05-29
Locations	1 site in France

-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

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+Arms and interventions

Arm	Type	Interventions	Description
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

+Outcome measures

Primary outcomes

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 [Baseline (The day of the polysomnography )]

Secondary outcomes

Mean value of the IVHF in the other sleep stages (N1, N2 and N3) [Baseline (The day of the polysomnography )]: Variations of the IVHF between subjects with severe SAS and healthy subjects for the other sleep stages
Mean value of other VFC variables in the different sleep stages (REM, N1, N2 and N3) [Baseline (The day of the polysomnography )]: Variations of the other markers of cardiac variability between subjects with severe SAS and healthy subjects for all sleep phases
Total score and sub-score of the SCOPA-AUT questionnaire (between 0-69), with the possibility of analysis of the different sub-scores. [Baseline (The day of the polysomnography )]: Variation of other nervous system components by standardized questionnaire between a group with severe SAS and a group of control subjects

+Eligibility

Sex: All, ages: 18 Years to 64 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
Service de Neurophysiologie - unité de médecine du Sommeil - CHU Lille	Lille	France	Recruiting

+Investigators

Philippe DERAMBURE, MD, Principal investigator, University Hospital, Lille