Role of Yoga on Obstructive Sleep Apnea (OSA)

Phase 2/3

Not yet recruiting

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

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.

Exclusion Criteria

1.Patientâ€™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.

Primary Outcome Measures

Name	Time	Method
1.Apnoea hypopnea index	Baseline, at 2 weeks,at 3 months, at 6 months, and at 12 months from baseline
2.Oxygen desaturation index (ODI)	Baseline, at 2 weeks,at 3 months, at 6 months, and at 12 months from baseline
3.Heart Rate Variability (HRV)	Baseline, at 2 weeks,at 3 months, at 6 months, and at 12 months from baseline

Secondary Outcome Measures

Name	Time	Method
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
Hamiltonâ€™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

Locations (2): All India Institute of Medical Sciences (AIIMS)
🇮🇳
South, DELHI, India
DAYANAND MEDICAL COLLEGE AND HOSPITAL
🇮🇳
Ludhiana, PUNJAB, India
All India Institute of Medical Sciences (AIIMS)
🇮🇳South, DELHI, India
GAUTAM SHARMA
Principal investigator
01126549326
drsharmagautam@gmail.com