Diagnostic Validation of the DreamKit Device Against Polysomnography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 306
- 试验地点
- 14
- 主要终点
- Intraclass Correlation Coefficient (ICC) of the Apnea Hypopnea Index
研究概览
简要总结
This study has been developed in order to demonstrate diagnostic efficacy of the DreamKit device against polysomnography.
详细描述
The primary objective of this study is to assess the diagnostic performance of the DreamKit device against the gold-standard comparator, polysomnography (PSG). Data collection will be completed within a single visit, in which participants will undergo simultaneous measurement using the DreamKit device and in-laboratory PSG.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged ≥18 years;
- •Fluent in English;
- •Able to provide informed consent.
排除标准
- •Self-reported habitual sleep duration of <4 hours/night on average ("How many hours sleep do you usually get per night?");
- •Circadian phase disorder, shift work, or any other issue/condition that would, in the opinion of the site investigator, reduce the likelihood of obtaining at least four hours of sleep during the overnight study;
- •History of allergic reactions to medical adhesives;
- •Skin rash or other dermatological condition that would impact correct placement of the DreamKit device and/or PSG sensors, and/or would be exacerbated by the presence of the device or sensors;
- •Presence of a pacemaker;
- •Severe medical condition (controlled or uncontrolled) that would impede data collection in the opinion of the site investigator, including the requirement for oxygen therapy;
- •[for those currently using overnight therapy]: Unwilling to withdraw from overnight therapy for a single night and/or clinically unsuitable to withdraw from overnight therapy in the opinion of the site investigator, with overnight therapy including but not limited to any form of PAP or ventilation, oral device including mandibular advancement devices or mouthguard for bruxism, nasal dilator strips, and/or positional device;
- •[for those currently using overnight therapy]: Considered by the site investigator to be at risk of an AE resulting from hypersomnolence the day after the overnight visit, such as a high-risk occupation including but not limited to a pilot or commercial driver;
- •An employee, or family member of an employee, of a company that designs, sells, or manufactures sleep related products (including Philips).
结局指标
主要结局
Intraclass Correlation Coefficient (ICC) of the Apnea Hypopnea Index
时间窗: Visit 2 (within six weeks of enrollment)
The primary endpoint is the intraclass correlation coefficient (ICC) for absolute agreement between the polysomnography (PSG) apnea-hypopnea index (AHI) and the DreamKit-AHI. The higher ICC indicates higher correlation/agreement between the PSG AHI and DreamKit AHI. The possible range of ICC values is 0 to 1.0. Number was the best option for the measure type because it was a correlation coefficient.
次要结局
- Intraclass Correlation Coefficient (ICC) of the Central Apnea Index(Visit 2 (within six weeks of enrollment))