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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06808464

Acronym

HRVSAS

Enrollment

Registered

2025-02-05

Start date

2025-05-14

Completion date

2027-02-28

Last updated

2025-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Apnea

Keywords

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

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

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Measure	Time frame	Description
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

Countries

France

Contacts

Primary ContactPhilippe DERAMBURE, PR

Philippe.DERAMBURE@chu-lille.fr0320445962

Outcome results