New Approach in the Study of the Autonomic Nervous System Through Cardiac Variability in Sleep Apnea Syndrome.
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Source: NCT06808464, who can take part
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Print a page for my doctorTrial details
- Who runs it
- University Hospital, Lille
- Trial code
- NCT06808464
- Record updated
- 29 May 2025
- Original description
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.Read full original descriptionShow less
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
Inclusion: 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: Cardiac rhythm disorder; Neurological or psychiatric pathology impacting on ANS; Control group (healthy subjects - 1); Complaint of sleep disorder; Known sleep disorder; Non-inclusion criteria:; 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.