Comparison of the SUNRISE© Device With Ventilatory Polygraphy for the Diagnosis of Obstructive Sleep Apnea Hypopnea Syndrome: Collection of Preliminary Data
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Apnea-hypopnea index (AHI)
研究概览
简要总结
Additional data on screening for obstructive sleep apnea/hypopnea syndrome (OSAHS) in patients with co-morbidities, such as diabetics and those with chronic respiratory diseases would enable current recommendations to evolve, with a view to promoting the widespread use of simplified techniques for OSAHS screening, particularly in patients with cardiorespiratory co-morbidities.
The primary objective of this observational multicentric pilot study is to compare the performance of the Sunrise® medical device with that of ventilatory polygraphy as part of routine screening for OSAHS in diabetic patients followed up in the diabetology department of the Strasbourg University Hospital, and in patients followed up in the pneumology consultation department of Mulhouse Hospital (GHRMSA).
详细描述
Secondary objectives
- To assess the correlation of the following parameters:
- dorsal Apnea-Hypopnea Index (AHI) measured by ventilatory polygraphy and dorsal Obstructive Respiratory Disturbance Index (ORDI) measured by Sunrise® device
- non-dorsal AHI measured by ventilatory polygraphy and non-dorsal ORDI measured by Sunrise® device
- To study the correlation between AHI measured by the Sunrise® medical device and desaturation index measured by ventilatory polygraphy.
Conduct of research
- At Strasbourg University Hospital, the study will be proposed to patients admitted for diabetic assessment who require ventilatory polygraphy.
- At Mulhouse hospital (GHRMSA), patients are referred to a pneumologist in case of suspected OSAHS and a ventilatory polygraphy is scheduled at home. Patients scheduled to undergo this examination will be invited to take part in the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged 18 or over;
- •Patient with a smartphone (Android or iOS) with Bluetooth and Internet connection and able to use the mobile application associated with the Sunrise© medical device;
- •Patient having a scheduled exploration by ventilatory polygraphy;
- •Non-opposition to participation in the research.
排除标准
- •Patient suffering from a psychiatric pathology or with a history of behavioral disorders;
- •Patient already treated for OSAHS;
- •Patient refusing to cut his beard (if too abundant to wear the Sunrise© device);
- •Patient suffering from a pathology affecting the rotation of the condyle in the temporomandibular joint;
- •Patient deprived of liberty by judicial or administrative decision;
- •Patients under court protection or legal guardianship.
结局指标
主要结局
Apnea-hypopnea index (AHI)
时间窗: Day 1
The apnea-hypopnea index (AHI) will be measured using the Sunrise® medical device and ventilatory polygraphy. It corresponds to the number of apnea-hypopnea episodes per hour of sleep.
次要结局
- Non dorsal ORDI(Day 1)
- Dorsal Obstructive respiratory disturbance index (ORDI)(Day 1)
- Dorsal AHI(Day 1)
- Non- dorsal AHI(Day 1)