A comparison of two peripheral arterial tonometry-based sleep devices for the diagnosis of obstructive sleep apnea
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- To assess the correlation of AHI as measured by One Sleep Test as compared to that by Level-1 polysomnography for the diagnosis of OSA
研究概览
简要总结
Rationale: The diagnosis is OSA is delayed due to late identification by the clinicians and time lost during waiting for a sleep study. Currently, the gold-standard test, a level 1 in-lab study has long waiting times in most hospitals and this has paved the way for the development of new diagnostic devices. Two such devices based on peripheral arterial tonometry principles have been developed (WatchPAT and One Sleep Test). WatchPAT has been tested in the Indian population recently by our group; however, the validation of OST with WatchPAT and PSG has not been done.
**Novelty:**This study will be the first of its kind to do a comparative evaluation of two PAT-based devices for OSA as compared to gold-standard level 1 PSG and assess the effect of arterial stiffness on device performance in these patients.
Objectives**:** To assess the correlation of Apnea-hypopnea index (AHI), time spent below 90% saturation, and ODI (Oxygen desaturation Index) as measured by One Sleep Test as compared to that by Level 1 PSG and WatchPAT 200 for the diagnosis of OSA. We will also assess the effect of arterial stiffness on these correlations.
**Methods:**We will include 99 patients with suspected OSA who are planning to undergo polysomnography in our department. After clinical evaluation, patients will undergo PSG with simultaneous recording on WatchPAT and One sleep test. All patients will undergo arterial stiffness measurement as well. The PSG will be reported as per AASM guidelines and WatchPAT and OST will have automated software-based reporting. We will analyze the correlation of AHI by OST and watchPAT along with the impact of arterial stiffness on this correlation and differences in AHI between the devices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Study participants should be adults (18 years of age or older)
- •Participants with clinical suspicion of OSA, who are referred for a sleep study
- •Participants should be able to understand and comply with the study procedures and requirements.
排除标准
- •Participants with a previous diagnosis of obstructive sleep apnea or receiving treatment for the same
- •Participants who are unable or unwilling to provide informed consent
- •Individuals with a history of significant psychiatric disorders or cognitive impairment that may interfere with their ability to participate or comply with the study requirements
- •Pregnant women or individuals who are breastfeeding
- •Patients with known peripheral arterial disease or any other condition that can affect the accuracy of peripheral arterial tonometry measurements
- •Inadequate data acquisition during level 1 polysomnography (less than 120 minutes of sleep time).
结局指标
主要结局
To assess the correlation of AHI as measured by One Sleep Test as compared to that by Level-1 polysomnography for the diagnosis of OSA
时间窗: At baseline
次要结局
- To assess the correlation of AHI as measured by One Sleep Test as compared to that by WatchPAT 200 for the diagnosis of OSA(At baseline)
- To assess the correlation between Time spent below 90% saturation between the two devices(At baseline)
- To assess the correlation between ODI (Oxygen desaturation Index), total sleep time, and sleep efficiency between OST and WatchPAT 200(At baseline)
- To assess the effect of stiffness index as measured using Artsens device on the correlation of AHI between the three devices(At baseline)
研究者
Saurabh Mittal
All India Institute of Medical Sciences, New Delhi