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

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

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

Study Overview

• Status: Recruiting
• Conditions: Sleep Apnea

• Study Type: Observational
• Enrollment (Estimated): 97

Contacts and Locations

• Study Contact: Name: Philippe DERAMBURE, PR; Phone Number: 0320445962; Email: Philippe.DERAMBURE@chu-lille.fr

Study Locations

• France
  • Lille, France
    • Recruiting
    • Service de Neurophysiologie - unité de médecine du Sommeil - CHU Lille
    • Contact: Philippe Derambure, Pr; Email: philippe.derambure@chu-lille.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Philippe DERAMBURE, MD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: January 29, 2025
• First Submitted That Met QC Criteria: January 29, 2025
• First Posted (Actual): February 5, 2025

Study Record Updates

• Last Update Posted (Actual): May 29, 2025
• Last Update Submitted That Met QC Criteria: May 22, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Autonomic nervous system; Machine Learning; Cardiac variability; Sleep apnea hypopnea syndrome; Automatic detection
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Apnea
• Other Study ID Numbers: 2021_0403; 2022-A01069-34 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No