Reliability of the Samsung Galaxy for the Detection of Moderate to Severe Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- 4% Apnea Hypopnea Index (AHI)
研究概览
简要总结
The study will test the reliability of the Samsung Galaxy for the Detection of Moderate to Severe Obstructive Sleep Apnea (OSA)
详细描述
A prospective cohort of 150 individuals 22 years or older with a prior diagnosis or with a high likelihood of having moderate to severe OSA, screened using STOP-Bang and Epworth Sleepiness Scale questionnaires will be recruited and will utilize the Samsung Galaxy Watch technology to monitor sleep patterns, oxygen saturation, PPG, and heart rate variability amongst other physiologic parameters. All data will be collected over the course of two intervention nights in the sleep lab and at home for three nights.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •22 years of age or older
- •High pre-test likelihood of moderate to severe obstructive sleep apnea (OSA) based on screening questionnaires (STOP-Bang and Epworth Sleepiness Scale); or prior diagnosis of moderate-severe OSA.
- •Able to provide informed consent confirmation
排除标准
- •Severe and/or other acute medical illnesses as determined by the Investigator, in particular: Cardiac conditions such as Congestive Heart Failure (CHF), atrial fibrillation, Hx of Movement disorders: Parkinson's, Tremor, Lung conditions: Chronic Obstructive Pulmonary Disease (COPD), chronic bronchitis, emphysema, pulmonary fibrosis, acute episode of flu, allergies, asthma.
- •Active comorbid sleep disorders, such as severe insomnia, restless legs syndrome, Periodic Leg Movement During Sleep (PLMS), narcolepsy, idiopathic hypersomnia
- •Severe and/or unstable psychiatric disorders such as mood, anxiety, or psychotic disorders
- •Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk
- •Inability to use a Samsung Galaxy device for sleep tracking
- •Inability to have two nights in the Stanford sleep lab.
- •Participants who are pregnant
- •Tattoos or scars covering the forearm area of both hands
研究组 & 干预措施
Samsung Galaxy Watch technology
All participants screened will utilize the Samsung Galaxy Watch technology to monitor sleep patterns, oxygen saturation, PPG, and heart rate variability amongst other physiologic parameters. All data will be collected over the course of two intervention nights in the sleep lab and at home for three nights
干预措施: Samsung Galaxy Watch (Diagnostic Test)
结局指标
主要结局
4% Apnea Hypopnea Index (AHI)
时间窗: Day 1 (Visit 1), Day 5 (Visit 2)
Assessment of the 4% Apnea Hypopnea Index to determine the severity of sleep apnea
次要结局
- User acceptance and feasibility of Galaxy Watch technology(Day 1 (Visit 1), Day 5 (Visit 2), At home monitoring (Day 2, 3 &4))
研究者
Robson Capasso
Professor of Otolaryngology - Head & Neck Surgery (OHNS)
Stanford University