Feasibility Evaluation of Sleep Apnea Screening with Photoplethysmography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Apnea Hypopnea Index(AHI)
研究概览
简要总结
The clinical study aims to develop and validate the TipTraQ system, created by PranaQ, a home sleep test for sleep apnea screening. The system comprises a wearable device and a cloud-based AI for estimating Total Sleep Time (TST) and Apnea-Hypopnea Index (AHI).
详细描述
Sleep-disordered breathing is a common disease that affects life function and quality of life, and it also imposes a great burden on the public health system. Obstructive sleep apnea accounts for the largest proportion of sleep-disordered breathing, and because of the oriental facial structure, the prevalence of sleep-disordered breathing is relatively high. The current gold standard for diagnosis OSA is polysomnography (PSG). Although the physiological information collected by PSG is complete and detailed, it requires a considerable amount of manpower and medical resources, and changes in the sleep environment also cause bias in the accuracy of inspection. So far, the tools for simple and accurate screening and diagnosis OSA are relatively limited. In this study, TipTraQ, a wearable device developed by PranaQ, was used to collect photoplethysmography (PPG) of patients during the night of PSG inspection. The reliability and validity analysis was carried out by comparing with the corresponding indicators of PSG, and the feasibility of TipTraQ as a tool for home sleep test (HST).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects from the age of 20 and older that have an indication for an in-lab PSG study.
排除标准
- •Heart transplant
- •Heart failure, New Youk Heart Association (NYHA) classification III or IV
- •Chronic opioid medication user
- •Devastating severe strokes, with the modified Rankin score (mRS)≥4
- •Tracheostomy
- •Incapable of comprehending and signing the informed consent and questionnaires, including but not limited to subjects with severe Alzheimer's, unconscious by head trauma, or of someone with limited mental capacity
- •Cannot correctly follow the order to use the TipTraQ device
结局指标
主要结局
Apnea Hypopnea Index(AHI)
时间窗: From the start of a single polysomnography study to the end of the recording, 1 night.
The combined average number of apneas and hypopneas that occur per hour of sleep
Oxygen Desaturation Index(ODI)
时间窗: From the start of a single polysomnography study to the end of the recording, 1 night.
Average desaturation episodes with a decrease in the oxygen saturation of ≥4% or 3% per hour
Total Sleep Time(TST)
时间窗: From the start of a single polysomnography study to the end of the recording, 1 night.
Total sleep time during the polysomnography (PSG)
次要结局
未报告次要终点
