Evaluation of Autonomic Activity in REM Sleep by a New Marker of Cardiac Variability in Subjects With Severe Obstructive Sleep Apnea Hypopnea Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Group healthy subjects - 1): absence of sleep disorder referenced in the ICSD-
- •Epworth Sleep Scale < 11
- •Pittsburgh Quality Sleep Index < 6
- •Berlin Questionnaire: < 2 positive categories
- •STOP BANG <3
- •HADS normal
- •Group 2 (subjects with severe SAS - 2): AHI > 30/h obstructive
排除标准
- •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
结局指标
主要结局
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
时间窗: Baseline (The day of the polysomnography )
次要结局
- 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 ))