Assessment of the Performance of the V2 Version of the Dreem Headband for EEG Sleep Monitoring Compared to a Gold Standard Polysomnography.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Sleep stages accuracy (Dreem vs. PSG consensus)
研究概览
简要总结
This study aims to evaluate the accuracy of automated sleep analysis by the Dreem dry-EEG headband and deep learning algorithm in comparison to the consensus of 5 sleep technologists' manual scoring of a gold-standard clinical polysomnogram (PSG) record in healthy adult volunteers during an overnight clinic-based sleep study.
详细描述
The study will enroll 25 adult volunteers who will undergo a one-night in-lab sleep study. All volunteers are first prescreened over the phone. Upon arrival at the research center, volunteers provide informed consent, are interviewed to confirm eligibility, and complete a detailed demographic, medical, health, sleep, and lifestyle survey. After the survey, participants are fitted with the PSG and the Dreem headband by the sleep technologist. During the PSG sleep study, the Dreem headband records EEG, pulse, oxygen saturation (SO2), movement, and respiratory rate.
Dreem's algorithms will be used to automatically stage the Dreem sleep data, and the results will then be compared to the consensus of 5 sleep technologists' manual scoring of the respective PSG records for the same individuals to determine the accuracy of Dreem's sleep staging algorithms.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Capable of providing informed consent
排除标准
- •Pregnant or nursing females
- •History of any severe comorbidities such as cardiac, neurologic, or psychiatric diseases/disorders in the last 12 months
- •Morbid obesity (BMI >= 40)
- •Use of benzodiazepines, nonbenzodiazepine (Z-drugs), or Gammahydroxybutyrate (GHB) the day/night of the study
研究组 & 干预措施
Healthy adults
Dreem
干预措施: Dreem (Diagnostic Test)
结局指标
主要结局
Sleep stages accuracy (Dreem vs. PSG consensus)
时间窗: Day 1
Cohen's kappa comparing the classification of AASM sleep stages at each 30-sec epoch determined automatically by the Dreem headband compared those determined by the consensus of 5 sleep technologists' scoring of each subject's PSG record from the same night.
次要结局
- Number of sleep eye movements (accuracy between Dreem and PSG consensus)(Day 1)
- Wake After Sleep Onset (WASO) time (accuracy between Dreem and PSG consensus)(Day 1)
- Time in N1 sleep stage (accuracy between Dreem and PSG consensus)(Day 1)
- Time in rapid eye movement (REM) sleep stage (accuracy between Dreem and PSG consensus)(Day 1)
- Number of sleep spindles (accuracy between Dreem and PSG consensus)(Day 1)
- Breathing frequency measurement (accuracy between Dreem and PSG consensus)(Day 1)
- Time in N2 sleep stage (accuracy between Dreem and PSG consensus)(Day 1)
- Time in N3 sleep stage (accuracy between Dreem and PSG consensus)(Day 1)
- Total Sleep Time (TST) (accuracy between Dreem and PSG consensus)(Day 1)
- Number of sleep slow oscillations (accuracy between Dreem and PSG consensus)(Day 1)