New Approach in the Study of the Autonomic Nervous System Through Cardiac Variability in Sleep Apnea Syndrome.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Sleep Apnea. Basic parameters: 18 years — 64 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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
Primary outcome measures
- 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 outcome measures (3)
- Mean value of the IVHF in the other sleep stages (N1, N2 and N3) [Time frame: Baseline (The day of the polysomnography )]
- Mean value of other VFC variables in the different sleep stages (REM, N1, N2 and N3) [Time frame: 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. [Time frame: Baseline (The day of the polysomnography )]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
France · 1 center
- Service de Neurophysiologie - unité de médecine du Sommeil - CHU Lille — Lille
Identifiers
NCT: NCT06808464 · 2021_0403 · 2022-A01069-34