| CTRI Number |
CTRI/2026/02/104670 [Registered on: 24/02/2026] Trial Registered Prospectively |
| Last Modified On: |
24/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of Yoga Nidra on Sleep in Patients with Coronary Artery Disease. |
|
Scientific Title of Study
|
Effect of Yoga Nidra on sleep efficiency in CAD patients with poor sleep quality: A randomized control study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gautam Sharma |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room No. 27,
Department of Cardiology,
C N, Center, AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
01126549326 |
| Fax |
|
| Email |
drgautamsharma12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Gautam Sharma |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room No. 27,
Department of Cardiology,
C N, Center, AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
01126549326 |
| Fax |
|
| Email |
drgautamsharma12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gautam Sharma |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room No. 27,
Department of Cardiology,
C N, Center, AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
01126549326 |
| Fax |
|
| Email |
drgautamsharma12@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ministry of Ayush, Ayush Bhawan, B Block, GPO Complex, INA, New Delhi – 110023. |
|
|
Primary Sponsor
|
| Name |
Ministry of Ayush |
| Address |
Ministry of AYUSH, Ayush Bhawan, B Block, GPO Complex, INA, New Delhi - 110023 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Gautam Sharma |
Center for Integrative Medicine and Research |
Room No. 7004
Convergence Block, Center for Integrative Medicine and Research, AIIMS, New Delhi.
South
DELHI |
01126549326
drgautamsharma12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I20-I25||Ischemic heart diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Sham Yoga Nidra |
Patients under control group will receive standard guideline recommended therapy along with sleep hygiene education and Sham Yoga Nidra Intervention over a period of 6 months. |
| Intervention |
Yoga Nidra |
Patients allocated under study group will be subjected to Yoga nidra in addition to sleep hygiene education and the standard guideline recommended therapy for 6 Months. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in sleep quality on polysomnography (Sleep efficiency) |
at baseline, 3 Months, 6 Months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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.
|
3 Months and 6 Months |
| 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).
|
3 Months, 6 Months and One Year |
| 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 |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
10/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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. - 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. - Depression and Anxiety - Serum Cortisol - Functional Status: Seatal angina questionnaire.
|