Clinical trial NCT06808464: New Approach in the Study of the Autonomic Nervous System Through Cardiac Variability in Sleep Apnea Syndrome.
Official title: Evaluation of Autonomic Activity in REM Sleep by a New Marker of Cardiac Variability in Subjects With Severe Obstructive Sleep Apnea Hypopnea Syndrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sleep Apnea
Keywords: Sleep apnea hypopnea syndrome
Autonomic nervous system
Cardiac variability
Automatic detection
Machine Learning
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2025-02-05
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Recruitment of patients after the diagnosis of severe SAS in the services of the University Hospital of Lille. The healthy subjects will be recruited through an advertisement in the general medicine networks of the Hauts de France region.

Brief 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 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

Primary outcomes:
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
timeFrame: Baseline (The day of the polysomnography )
Secondary outcomes:
measure: Mean value of the IVHF in the other sleep stages (N1, N2 and N3)
timeFrame: Baseline (The day of the polysomnography )
measure: Mean value of other VFC variables in the different sleep stages (REM, N1, N2 and N3)
timeFrame: Baseline (The day of the polysomnography )
measure: Total score and sub-score of the SCOPA-AUT questionnaire (between 0-69), with the possibility of analysis of the different sub-scores.
timeFrame: Baseline (The day of the polysomnography )
Other outcomes:
Locations:
city: Lille
country: France
facility: Service de Neurophysiologie - unité de médecine du Sommeil - CHU Lille
Study officials:
affiliation: University Hospital, Lille
name: Philippe DERAMBURE, MD
role: PRINCIPAL_INVESTIGATOR
References: