Effect of yoga on health-related status and cardiovascular risk factors among obstructive sleep apnoea patients: A Multi-Centric Randomized Controlled Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- 1.Apnoea hypopnea index
研究概览
简要总结
The current study will be a multi-centric, single blinded, parallel group, randomized control trial with four assessment point i.e. Baseline, after 2 weeks, 3 months, 6 months and 12 months. The study will be conducted at two centers i.e. the Dayananda Medical College and Hospital, Ludhiana and Center for Integrative Medicine and Research (CIMR), AIIMS, New Delhi. The participants will be screened and all consenting participants will be recruited from outpatient services of neurology and pulmonary medicine department and from sleep study lab of Dayananda Medical College and Hospital, Ludhiana, after which they will be randomly divided into two groups with an allocation ratio of 1:1. All patients will be assessed for primary and secondary outcomes which include general metabolic measures and inflammatory biomarkers along with neuropsychological measures such as depression, anxiety, memory and QoL at baseline followed by assessments at 2 weeks, 3 months, 6 months and 12 months from baseline. The intervention group will receive the intervention (as defined below) whereas the control will continue to receive standard care at each of the center.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified randomization
- 盲法
- Participant, Investigator and 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
- •1.Patients of all genders and age between 18-70 years.
- •2.Patients from Delhi NCR for study settings in Delhi.
- •3.Medical history which is compatible with OSA and AHI more than 15 per hour.
- •4.Availability of time to include physical activity in their daily routine and to come for the contact classes and investigations as per the protocol.
- •5.Not been engaged in regular yoga practice or any other alternative medicine for the same desired effect.
排除标准
- •1.Patient’s refusal for Polysomnography.
- •2.Patients on CPAP.
- •3.Patients with a well-documented chronic history of congestive heart failure, chronic renal failure or chronic liver failure.
- •4.Patients having very severe hypoxemia (oxygen saturation <80% for >10% of recording time).
- •5.Pregnancy 6.Morbid obesity, Hypothyroidism 7.Patients underwent any metabolic surgery 8.Recent trauma to upper respiratory tract 9.Patients on systemic corticosteroid treatment 10.Inability to perform yoga exercises due to orthopaedic or musculoskeletal problems.
- •11.Patients currently participating in any other clinical trials in the same hospital or any other sites.
结局指标
主要结局
1.Apnoea hypopnea index
时间窗: Baseline, at 2 weeks,at 3 months, at 6 months, and at 12 months from baseline
2.Oxygen desaturation index (ODI)
时间窗: Baseline, at 2 weeks,at 3 months, at 6 months, and at 12 months from baseline
3.Heart Rate Variability (HRV)
时间窗: Baseline, at 2 weeks,at 3 months, at 6 months, and at 12 months from baseline
次要结局
- Stress and Inflammatory biomarkers(Baseline,at 3 months, at 6 months, and at 12 months from baseline)
- Neuropsychological Evaluation Screening Tool (NEST) and Hindi Mental Status Examination (HMSE)(Baseline, at 2 weeks,at 3 months, at 6 months, and at 12 months from baseline)
- Wechsler Memory Scale- III (WMS III) Indian Edition(Baseline, at 2 weeks,at 3 months, at 6 months, and at 12 months from baseline)
- The Pittsburgh Sleep Quality Index (PSQI)(Baseline, at 2 weeks,at 3 months, at 6 months, and at 12 months from baseline)
- Hamilton’s Depression Questionnaire (HAM-D)(Baseline, at 2 weeks,at 3 months, at 6 months, and at 12 months from baseline)
- The Hamilton Anxiety Rating Scale (HAM-A)(Baseline, at 2 weeks,at 3 months, at 6 months, and at 12 months from baseline)
- WHO QoL BREF questionnaire(Baseline, at 2 weeks,at 3 months, at 6 months, and at 12 months from baseline)
- General metabolic parameters(Baseline, at 2 weeks,at 3 months, at 6 months, and at 12 months from baseline)