Effect of Yoga Nidra on sleep efficiency in CAD patients with poor sleep quality: A randomized control study
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Improvement in sleep quality on polysomnography (Sleep efficiency)
研究概览
简要总结
Summary:
Research Question: Do "Yoga Nidra" sessions prove effective in improving sleep quality among CAD patients with poor sleep quality
Primary Objective:
To determine the effect of Yoga Nidra in improving sleep quality on polysomnography among CAD patients with poor sleep quality.
Secondary Objective:
-To determine improvement in daytime, 24-hour mean BP, nocturnal BP and nocturnal dip.
-
To determine improvement in quality of life and psychological burden.
-
To determine the reduction in early morning blood cortisol levels.
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To determine change in angina class, antianginal medications, hospitalisation, or physician contact for worsening of the symptoms and functional status.
Methods:
Study Design: Randomized Controled trail.
Population: Coronary artery disease patients with poor sleep quality.
Intervention: Yoga Nidra
Comparator: Sham Yoga Nidra
Primary Outcome: Sleep efficiency on polysomnography
Secondary Outcomes:
-Total sleep time, sleep architecture, sleep latency, arousal index on PSG.
-BP parameters on ambulatory blood pressure monitoring.
-Quality of Life: SF-36.
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Depression and Anxiety
-
Serum Cortisol
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Functional Status: Seatal angina questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient with age group of 30 to 80 years.
- •Patient with coronary artery disease, either with chronic coronary syndrome or after 4 months of acute coronary syndrome.
- •Patients who are not planned for revascularization.
- •Patients who were revascularized at least 6 weeks back Patients with CCS Angina score of less than II.
排除标准
- •Patients who are regular practitioners of yoga.
- •Patients suffering from any neuropsychiatric illness.
- •Patients who are unable to lie down still due to any medical condition.
- •Patients who are diagnosed with a case of obstructive sleep apnea.
- •Patients with left ventricular ejection fraction (LVEF) less than or equal to 30 percent.
结局指标
主要结局
Improvement in sleep quality on polysomnography (Sleep efficiency)
时间窗: at baseline, 3 Months, 6 Months.
次要结局
- Improvement in other Polysomnography parameters like Sleep architecture (% N1, N2,N3 and REM sleep), Total Sleep Time (Night), Total sleep time (24 hours), Sleep Latency, sleep fragmentation, Arousal Index.
- ABPM parameters ex. Daytime BP, 24 hour and Mean BP reduction, Nocturnal Dip in SBP.(3 Months and 6 Months)
- Echocardiography Diastolic Function (E/e’) improvement.(3 Months and 6 Months)
- Improvement in Quality of life (SF 36 Questionnaire).(Improvement in Mental Well being (Becks Questionnaire).)
- To determine reduction in Heart rate and Salivary cortisol levels.(3 Monts and 6 Months)
- To determine change in angina class, antianginal, medications, hospitalization or physician contact for worsening of symptoms and change in functional status (Seattle angina questionnaire)(3 Months, 6 Months and One Year)
- MACCE(One Year)
研究者
Gautam Sharma
All India Institute of Medical Sciences, New Delhi