Screening Moderate to Severe Obstructive Sleep Apnea With Wearable Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- AUC of ROC
研究概览
简要总结
The goal of this study is to find the best method to use Wellue O2 ring to screen for moderate to severe obstructive sleep apnea. The method that investigators use to screen for moderate to severe obstructive sleep apnea is oxygen desaturation index(ODI). The main questions of this study are
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What is the best ODI to screen for moderate to severe obstructive sleep apnea?
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What are the sensitivity, specificity and AUC of the study? In this study, participants are recruited from Sleep center of Thammasat prior to polysomnography. All participants in this study will
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Undergo polysomnography according to Sleep center of Thammasat protocol 2. Wear Wellue O2 ring when undertaking polysomnography If the polysomnography is switch to PAP titration Wellue O2 ring will be taken out.
Data of Oxygen data from Wellue O2 ring are collected and compared with AHI. Investigators will find the best ODI to screen for obstructive sleep apnea.
详细描述
Background:
- Obstructive sleep apnea is a highly prevalent sleep-related disease.
- Moderate to severe obstructive sleep apnea is linked with traffic accident and other medical condition such as hypertension, pulmonary hypertension, myocardial infarction, stroke and diabetes mellitus
- Screening for obstructive sleep apnea using questionaires such as STOP-BANG and ESS (Epworth sleepiness scale) provide good sensitivity but low specificity
- Polysomnography used to diagnosed obstructive sleep apnea has limited assessibility and prolonged waiting time.
- Overnight pulse oximetry had been used to screen for obstructive sleep apnea and provided good sensitivity and specificity for screening obstructive sleep apnea using ODI (Oxygen desaturation index)
- Wellue O2 ring, a commercial grade pulse oximeter, with a frequency of measuring oxygen saturation of 0.25 Hz (compare to overnight pulse oximetry of 1 Hz) can measured oxygen saturation overnight with lower cost than overnight pulse oximetry (medical grade device)
- In this study, investigators want to find the best ODI to use to screen for moderate to severe obstructive sleep apnea. Investigators will find the sensitivity specificity and AUC of ROC curver in each ODI.
Outcome
- Sensitivity, Specificiy and area under the curve of ROC curve of each ODI. Sample size calculation
- Referencing previous studies (Kapur VK, Auckley DH, Chowdhuri S, et al. Clinical Practice Guideline for Diagnostic Testing for Adult Obstructive Sleep Apnea: An American Academy of Sleep Medicine Clinical Practice Guideline. J Clin Sleep Med. 2017;13(3):479-504. Published 2017 Mar 15. doi:10.5664/jcsm.6506) The sensitivity of single channel home sleep test is 73% using Z = 1.96 and prevalence of 0.64 and d = 0.1 investigators get a population of 118 people. Investigators collected 42 more people in case of total sleep time < 2 hours.
Recruitment
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age >= 18 years old
- •Undertaking polysomnography at Sleep center of Thammasat
排除标准
- •Patient with pacemaker or intra-cardiac defibrillator
- •Patient suspected to have periodic limb movement disorder, insomnia, parasomnia, narcolepsy, obesity hypoventilation syndrome
- •Patient who cannot wear Wellue O2 ring
- •Patient suspected to have congestive heart failure, COPD, neuromuscular disorder
- •Patient who have baseline O2 saturation below 92%
- •Patient who have scleroderma or having Raynaud phenomenon
结局指标
主要结局
AUC of ROC
时间窗: through study completion, an average of 1 year
Area under the curve of receiver operator curve of each ODI
Sensitivity
时间窗: through study completion, an average of 1 year
Sensitivity of each ODI
Specificity
时间窗: through study completion, an average of 1 year
Specificy of each ODI
次要结局
未报告次要终点
研究者
James Tisyakorn
Doctor
Thammasat University Hospital