Effect of Longitudinal Sleep Monitoring on Diagnosis and Treatment Decision in Patients With Suspected Obstructive Sleep Apnea (ELSA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- The accuracy of 1-13 nights of pulse-oximetry compared to the mean ODI of 14 consecutive nights
研究概览
简要总结
Obstructive sleep apnea (OSA) is a highly prevalent sleep-disordered breathing disease, caused by recurrent episodes of partial or complete collapse of the upper airway during sleep, resulting in intermittent hypoxia, fragmented sleep, fluctuations in blood pressure, and increased sympathetic nervous system activity. A single-night sleep study (i.e. respiratory polygraphy or polysomnography) is currently considered to be the gold standard for diagnosing OSA. However, recent studies suggest a significant intra-individual night-to-night variability of respiratory events, leading to the hypothesis that one single-night study might not reflect an accurate picture of the disease.
Part A: Patients with suspected obstructive sleep apnea, referred to our clinic, undergo the regular diagnostic procedure recommended by the current guidelines. In addition to the in-hospital single-night sleep study, these patients will perform 14 nights of pulse-oximetry at home. By computing and analysing sensitivity and specificity of every additional night, the investigator will answer the questions how many nights of sleep monitoring by home oximetry are necessary to diagnose OSA reliably, and how longitudinal sleep monitoring could reduce the number of false-negative and false- positive results compared to the in-hospital single-night study.
Part B: Based on the patients' data of part A, the investigator will develop a questionnaire and present anonymized cases to experts in the field of sleep medicine. Thereby, the investigator will evaluate if the additional information of repeated nocturnal pulse-oximetries changes the experts' decision making regarding diagnosis and treatment of OSA.
In a second step, the investigator will perform a classical Delphi study with a panel of experts in sleep medicine to establish consensus on repeated sleep studies and how they should be used for diagnosis and treatment in patients with suspected OSA.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed consent
- •Suspected obstructive sleep apnea
- •≥18 years old
排除标准
- •Suspected or diagnosed sleeping-disordered breathing other than OSA
- •Moribund or severe disease prohibiting protocol adherence especially COPD GOLD III-IV and heart failure NYHA III-IV
- •Patients receiving oxygen therapy or home ventilation
- •Continuous positive airway pressure treatment for OSA at baseline
- •Physical or intellectual impairment precluding informed consent or protocol adherence
- •Pregnant patients
结局指标
主要结局
The accuracy of 1-13 nights of pulse-oximetry compared to the mean ODI of 14 consecutive nights
时间窗: 14 nights of pulse-oximetry
"Sensitivity" and "specificity" for every additional night will be assessed
Decision making of a panel of experts in the field of sleep medicine regarding diagnosis and severity of OSA (no OSA, mild, moderate, severe) with/without the additional information of longitudinal sleep monitoring
时间窗: 14 nights of pulse-oximetry
次要结局
- Decision making of a panel of experts in field of sleep medicine regarding treatment decisions (CPAP yes/no) with/without the additional information of longitudinal sleep monitoring(14 nights of pulse-oximetry)
- ODI variability measured in 14 consecutive nights of pulse-oximetry(14 nights of pulse-oximetry)
- Change of OSA severity class (no OSA, mild, moderate, severe OSA) during 14 nights of pulse-oximetry due to ODI variability(14 nights of pulse-oximetry)
- Change of OSA severity class (no OSA, mild, moderate, severe OSA) diagnosed by in-hospital single-night sleep study vs repeated measurements by pulse-oximetry(14 nights of pulse-oximetry)
- Establish consensus on repeated sleep studies and their use in diagnosis and treatment in patients with suspected OSA(14 nights of pulse-oximetry)
研究者
Malcolm Kohler
Head of the department of pulmonology
University of Zurich