A randomized study to assess the efficacy of yoga in mild and moderate OSA patients
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 221
- 试验地点
- 1
- 主要终点
- To assess the benefits of yoga in reducing mild to moderate OSA
研究概览
简要总结
This is a randomized, open label, study to find out the efficacy of yoga among mild to moderate OSA patient. Total duration of the project is 3 years. Patients shall be recruited in accordance with the inclusion criteria. Randomized shall be done using computer generated random sequence using sequentially numbered, sealed, opaque envelopes. Prior to study, participants will be given complete information about the study procedure and all doubts regarding this study were clarified. Written informed consent will be obtained from each participant. Recruited patients will be admitted for Polysomnography within one month of recruitment. The patients shall be called after 6 months for PSG to see the effect of yoga.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Both male and female patients (age above 18 years and below 70 years) of Mild and Moderate OSA (who refuse to use CPAP), visiting to the outpatient department of Neurology, AIIMS, New Delhi.
- •Not satisfied with CPAP.
- •Has given the informed consent prior to any study related procedure.
排除标准
- •â€¢Patients below 18 years of age •Patients with severe OSA.
- •â€¢Patient who has not given written informed consent.
- •â€¢Patient with severe OSA •Pregnant women.
结局指标
主要结局
To assess the benefits of yoga in reducing mild to moderate OSA
时间窗: Baseline, 6 months
次要结局
- To determine the safety of yoga in patients of mild and Moderate OSA patients(Baseline, 6 months)
- To access the changes in BP, BMI and metabolic parameters after yoga(Baseline, 6 months)