Assessment of the Performance of the Dreem 3 System for EEG Sleep Monitoring in the Lab Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 4
- 主要终点
- Performance of the automatic sleep stage scoring of the Dreem 3 System compared to the consensus of 3 independent certified sleep scorers realized on the polysomnography signal.
研究概览
简要总结
The objective of the clinical investigation is to assess the performance of the Dreem 3 System for sleep assessment compared to a FDA-cleared PSG assessment and human sleep expert scoring in a population experiencing insomnia symptoms.
详细描述
Subjects enrolled in the study will come to the sleep laboratory around 8 pm. Their involvement in the protocol will only require them to be equipped by the technician with Dreem 3 in addition to the PSG reference system. This involves the technician placing all the PSG electrodes on the subject's head as per normal practice, and then positioning the Dreem 3 headband so that both devices can operate simultaneously. The subject will be allowed to go to his/her room and do quiet activities (reading, film watching, chatting) prior to sleeping. At the end of the night, the technician will remove the Dreem 3 headband and the PSG.
A technical quality control will be performed on the collected data in accordance with the standard operating procedures, as defined in the study protocol. Recordings that do not meet the quality control criteria will be excluded from further analysis.
Subjects will receive the PSG report at the end of the study.
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.
- •Able to read, understand and sign an informed consent form.
- •Subjects with stable disease or/and taking stable medications for at least 2 months can be included under Principal Investigator or Sub-Investigator discretion
- •Self-reported insomnia symptoms (by means of a questionnaire completed by the participant before their visit to the sleep lab) as defined by International Classification of Sleep Disorders, third edition (ICSD-3), confirmed by a clinician.
排除标准
- •Female subjects who are pregnant, or breastfeeding.
- •Subject under 22 and above 70 years old inclusive.
- •Not able to read, understand and sign an informed consent form
- •Subjects with BMI ≥ 40
- •Taking medications that induce somnolence or wakefulness, or that can interfere with sleep recording:
- •If the subject is taking OTC medications that can induce somnolence or wakefulness, he/she must not take it the day of the measurement.
- •Prescription only drugs that induce somnolence or wakefulness must be stopped one week before, as PI or Sub-I discretion and/or review with subject's physician.
- •Subjects previously diagnosed with Obstructive Sleep Apnea (OSA), REM Sleep Disorder, Narcolepsy, Hypersomnia, or significant difficulty breathing due to underlying condition(s), or subjects diagnosed with Central Nervous System (CNS) disease.
- •Subjects that suffer from an unstable disease
- •Any incidental finding on the Polysomnography reference system, happening during the study recording, that interferes with eligibility (probable moderate/severe undiagnosed OSA)
- •Subjects who may experience fitting difficulties with the headband, including people with head circumference < 53cm, or a hairstyle impeding the sensor placement (tight braids, hair extension, dreadlocks...) as determined by the investigator.
结局指标
主要结局
Performance of the automatic sleep stage scoring of the Dreem 3 System compared to the consensus of 3 independent certified sleep scorers realized on the polysomnography signal.
时间窗: Day 1
次要结局
- Total time spent in N3 sleep stage(Day 1)
- Total time spent in REM sleep stage(Day 1)
- LPS (Latency to Persistent Sleep)(Day 1)
- Total time spent in N1 sleep stage(Day 1)
- Respiratory Rate(Day 1)
- TST (Total Sleep Time)(Day 1)
- SE (Sleep Efficiency)(Day 1)
- Total time spent in N2 sleep stage(Day 1)
- SOL (Sleep Onset Latency)(Day 1)
- WASO (Wake After Sleep Onset)(Day 1)