Sleep Apnea : Diagnosis and Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Performance of the ApneaBand to detect sleep apnea
研究概览
简要总结
This prospective study aims to evaluate a new medical screening method to detect and discriminate sleep apnea-hypopnea events. A new device called ApneaBand will be tested to propose a new screening method facilitating the diagnosis and monitoring of the sleep apnea syndrom, still underdiagnosed. This device will be tested in comparison with polysomnography (PSG), the gold standard reference method of sleep apnea diagnosis.
详细描述
The objective of this study is to dertermine the performance of the ApneaBand, a new non-intrusive and portable device, in detecting sleep apnea, in comparison with PSG.
40 apneic and non apneic subjects will wear the ApneaBand recording the different sleep stages and the occurency of apnea-hypopnea sleep events through four sensors including oximetry (oxygen saturation), photoplethysmography (pulse wave), electrodermal activity and tri-axial accelerometer (movements).
Inclusion visit will be proceeded at the University Hospital Grenoble-Alpes ; polysomnography and mesures by the ApneaBand will be proceeded at the patient's home by IC@dom. Patients will be equiped with PSG + ApneaBand during the first night and with ApneaBand only the second night.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with moderate or severe obstructive sleep apnea (OSA), diagnosed by polygraphy or PSG for less than 2 years, and not treated for that.
- •Non apneic person (Berlin score = 0 or 1)
- •Person be able to use the personal health monitoring device ApneaBand
- •Be legally able to give consent
- •Person affiliated to social security
排除标准
- •Patient already treated for OSA
- •Patient equipped with an electric medical device (non-exhaustive examples: cardiac pace maker, cochlear implant, neuro-stimulator)
- •Being unable to understand and to follow recommendations for the study due to cognition or language problems
- •Pregnant women, feeding and parturient
- •Person under administrative or judicial control, or who is protected under the act
- •Person in exclusion period for another study
- •Person which would perceive more than 4500 euros of compensation because of its participation in other clinical studies in 12 months preceding this study
结局指标
主要结局
Performance of the ApneaBand to detect sleep apnea
时间窗: 3 days
Performance of the ApneaBand device in detecting moderate to severe sleep apnea (defined by an Apnea-Hypopnea Index (AHI) ≥ 15 events/hour), in comparison with PSG
次要结局
- Performance of the ApneaBand to mesure the apnea severity(3 days)
- Internal reproductibility of AHI measurement by the ApneaBand(3 days)
- ApneaBand algorith validation for AHI measurement(3 days)
- Skin tone variability(3 days)
- External reproductibility of AHI measurement by the ApneaBand(3 days)
- Sleep stage detection by ApneaBand(3 days)