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NCT Number: NCT06808464

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

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Key information

Conditions

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

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Lille, France

Location status: Recruiting

Location contact

Philippe Derambure, Pr

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

    Time frame: Baseline (The day of the polysomnography )

Secondary outcomes

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

    Time frame: Baseline (The day of the polysomnography )

    Variations of the IVHF between subjects with severe SAS and healthy subjects for the other sleep stages

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

    Time frame: 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

  3. Total score and sub-score of the SCOPA-AUT questionnaire (between 0-69), with the possibility of analysis of the different sub-scores.

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Philippe DERAMBURE, PR

CONTACT

[email protected]

0320445962

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

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

Acronym: HRVSAS

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 5, 2025
Registry last updated
May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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