Assessment of the Stability, Robustness and Usability of the Dreem 3 System for EEG Sleep Monitoring in the Home Setting, in an Insomnia Population.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- TST Correlation
研究概览
简要总结
There is an unmet medical need for monitoring sleep for multiple nights in a patient's home, without the inconvenience of traveling and staying overnight in a medical center, and without the need for a technician to set up a polysomnography (PSG) device at the patient's home. Several disorders, and particularly sleep disorders, are associated with insomnia symptoms, and longitudinal sleep assessment may support a better understanding and management of these patients, who currently seldom access sleep lab PSG.
On one hand, this study aims at demonstrating whether the final device's user interface supports safe and effective use when being used at home over multiple nights.
On the other, the study aims at confirming that stable and consistent data are measured in the device's actual use, for the records to be clinically usable in daily practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must be ≥ 22 and ≤ 70 years old inclusive, including:
- •8 subjects under 55 years old.
- •7 subjects over 55 years old.
- •Subjects who are under the care of a sleep clinician for experiencing insomnia symptoms.
- •Subjects have wifi connection at their home.
- •Subjects have a smartphone where they can install the Alfin App.
- •Subjects agree to not having abnormal drugs or alcohol consumption 24 hours before the start of the measurement, and during the 3 days of measurement.
- •Able to read, understand and sign an informed consent form.
排除标准
- •Under 22 and above 70 years old inclusive.
- •Obstructive sleep apnea diagnosis with ongoing CPAP therapy.
- •Abnormal drugs or alcohol use during the measurement part of the study.
- •Head circumference < 53 cm or device fitting issues as determined during training.
- •Not able to read, understand and sign an informed consent form.
结局指标
主要结局
TST Correlation
时间窗: 3 nights
Pearson's Correlation between the total time (in minutes) the subject spends asleep (TST) as automatically determined by the Dreem 3S compared to the TST automatically determined by the WatchPAT One (WP1) device on the same night.
Dreem 3 System usability
时间窗: 1 day
As determined by the System Usability Scale. The System Usability Scale establishes a score (the SUS score), between 0 and 100. A score of 68 indicates average performance of a system. A score \> 68 indicated the system's usability is above average.
次要结局
- ΔTST Correlation(3 nights)