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

NCT06808464 | Recruiting

• 2 other identifiers: 2021_04032022-A01069-34
• Study Type: observational
• Target: 97
• Locations: 1 country
• Sites: 1

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

Conditions

Sleep Apnea

Keywords

Sleep apnea hypopnea syndrome; Autonomic nervous system; Cardiac variability; Automatic detection; Machine Learning

Outcome Measures

Primary Outcomes (1)

• 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 (3)

• Mean value of the IVHF in the other sleep stages (N1, N2 and N3)

  Baseline (The day of the polysomnography )

• Mean value of other VFC variables in the different sleep stages (REM, N1, N2 and N3)

  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.

  Baseline (The day of the polysomnography )

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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
• Control group (healthy subjects - 1):
• Sleep pathology detected by polysomnography
• Total sleep time less than 4 hours
• Recording technically not usable

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Service de Neurophysiologie - unité de médecine du Sommeil - CHU Lille

Lille, France

RECRUITING

MeSH Terms

Conditions

Sleep Apnea Syndromes; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Philippe DERAMBURE, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe DERAMBURE, PR

CONTACT

0320445962; Philippe.DERAMBURE@chu-lille.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: February 5, 2025
• Study Start: May 14, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: May 29, 2025

Record last verified: 2025-05

Locations

FR (1)