ICD-10 condition:125.1, Atherosclerotic heart disease of native coronary artery Circulatory System
Conditions
Interventions
Eligible participants who give written consent for participation will be randomized into two arms, intervention and comparator groups, using a simple randomization method with an allocation ratio of 1
however, the outcome assessors will be blinded to the allocation of the subjects.
Intervention group: ‘Yoga Nidra’+ 'Sleep hygiene' sessions for three months
Comparator group: 'Sleep hygiene' session
Sponsors
All India Institute of Medical Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient with age group of 30 – 80 years old 2. Both sexes 3. Patient with coronary artery disease, either with Chronic coronary syndrome or after 4 months of Acute coronary syndrome. 4. Patients who are not planned for revascularization. 5. Patients who were revascularized at least 6 weeks back CCS Angina = II.
Exclusion criteria
Exclusion criteria: 1. Patients who are regular practitioners of yoga. 2. Patients suffering from any neuro-psychiatric illness. 3. Patients who are unable to lie down still due to any medical condition. 4. Patients who are diagnosed case of Obstructive Sleep Apnea. 5. Patients with Left ventricular ejection fraction (LVEF) less than or equal to 30 %.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sleep quality measured using an actigraphy at baseline and after 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary outcome measures will be assessed at baseline and after 3 months: 1. Total Sleep time (night), total sleep time (24 hours), sleep latency, and Sleep fragmentation index measured using an actigraphy 2. Daytime blood pressure (BP), 24-hour and mean BP reduction, and nocturnal dip in systolic BP measured using ambulatory blood pressure monitoring (ABPM) 3. Diastolic function measured using echocardiography 4. Improvement in quality of life measured using the Short-Form-36 questionnaire (SF 36) 5. Mental well-being measured using Beck's Depression Inventory 6. Reduction in salivary cortisol levels measured using electrochemiluminescence immunoassay (ECLIA)/ enzyme-linked immunosorbent assay(ELISA)/ liquid chromatography-mass spectrometry (LC-MS) 7. Change in angina class, antianginal medications, hospitalization or physician contact for worsening of symptoms measured using clinical interviews | — |
Countries
India
Contacts
Public ContactGautam Sharma
Outcome results
None listed