Application of non-linear analysis of oxygen saturation for the diagnosis of obstructive sleep apnoea and its correlation with cardiovascular risk in Indian subjects
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- To derive and validate the use of non-linear analysis in the Indian overweight/obese population in detecting OSA
研究概览
简要总结
The currently available gold-standard device for the diagnosis of OSA is in-lab PSG which requires patients to visit a sleep lab and stay overnight. However, this may be uncomfortable to many and may hamper their sleep leading to inadequate data acquisition.
The use of simpler and cheaper equipment to do this would help countries (including India) where resources are stretched, to test more individuals and enable screening of at risk individuals (i.e. those that are overweight and obese). Furthermore, the development of novel metrics that capture the complexity of physiological signals will enable cardiovascular risk stratification such that treatment can be targeted appropriately in high-risk individuals.
Most of the work done thus far with regards to hypoxic burden has been mainly in a Caucasian population, with the relevance in an Indian population less known.
研究设计
- 研究类型
- Observational
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
- •BMI more than 23 kg/ m2.
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
- •Inadequate data acquisition during level 1 polysomnography (less than 120 minutes of sleep time).
结局指标
主要结局
To derive and validate the use of non-linear analysis in the Indian overweight/obese population in detecting OSA
时间窗: At Baseline only
a. To retrospectively apply non-linear analysis to 200 historic sleep studies
时间窗: At Baseline only
b. To determine a cut-off that can be used to predict OSA
时间窗: At Baseline only
c. Prospectively validate the use of non-linear analysis in 200 prospective patients
时间窗: At Baseline only
次要结局
- 2) To determine if non-linear analysis can also predict cardiovascular risk in an overweight/obese Indian population with SDB (OSA)(At Baseline only)
研究者
Saurabh Mittal
All India Institute of Medical Sciences, New Delhi