| CTRI Number |
CTRI/2017/08/009231 [Registered on: 02/08/2017] Trial Registered Prospectively |
| Last Modified On: |
02/08/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of yoga as an intervention for Obstructive Sleep Apnea |
|
Scientific Title of Study
|
A randomized study to assess the efficacy of yoga in mild and moderate OSA patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manjari Tripathi |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences (AIIMS), New Delhi, India |
| Address |
Room No 705,
Department of Neurology,
All India Institute of Medical Sciences, New Delhi
South West
DELHI
110029
India |
| Phone |
011-26594494 |
| Fax |
|
| Email |
mtripathiaiims@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Manjari Tripathi |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences (AIIMS), New Delhi, India |
| Address |
Room No 705,
Department of Neurology,
All India Institute of Medical Sciences, New Delhi
DELHI
110029
India |
| Phone |
011-26594494 |
| Fax |
|
| Email |
mtripathiaiims@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Manjari Tripathi |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences (AIIMS), New Delhi, India |
| Address |
Room No 705,
Department of Neurology,
All India Institute of Medical Sciences, New Delhi
DELHI
110029
India |
| Phone |
011-26594494 |
| Fax |
|
| Email |
mtripathiaiims@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Ansari Nagar East, New Delhi-110029 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Ansari Nagar East, Gautam Nagar, New Delhi-110029 |
| Type of Sponsor |
Government medical college |
|
|
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 Manjari Triapthi |
All India Institute of Medical Sciences, New Delhi |
OPD Unit III, Department of Neurology, All India Institute of Medical Sciences, Ansari Nagar East, Gautam Nagar, New Delhi-110029
South West
DELHI |
011-26594494
mtripathiaiims@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, All India Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Obstructive Sleep Apnea , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard Care |
Standard care would consist of balanced diet and weight control |
| Intervention |
Yoga |
Patients shall be administered standardized yoga interventon consisting of Anulom Vilom, Ujjayi Pranayam, Sheetali and Sheetkari, Bhramari Pranayam and Simhasana |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) Both male and female patients (age above 18 years and below 70 years) of Mild and Moderate OSA (who refuse to use CPAP), visiting to the outpatient department of Neurology, AIIMS, New Delhi.
2) Not satisfied with CPAP.
3) Has given the informed consent prior to any study related procedure
|
|
| ExclusionCriteria |
| Details |
• Patients below 18 years of age
• Patients with severe OSA.
• Patient who has not given written informed consent.
• Patient with severe OSA
• Pregnant women.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the benefits of yoga in reducing mild to moderate OSA |
Baseline, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the safety of yoga in patients of mild and Moderate OSA patients |
Baseline, 6 months |
| To access the changes in BP, BMI and metabolic parameters after yoga |
Baseline, 6 months |
|
|
Target Sample Size
|
Total Sample Size="221"
Sample Size from India="221"
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)
|
03/10/2017 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
No publication as yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a randomized, open label, study to find out the efficacy of yoga among mild to moderate OSA patient. Total duration of the project is 3 years. Patients shall be recruited in accordance with the inclusion criteria. Randomized shall be done using computer generated random sequence using sequentially numbered, sealed, opaque envelopes. Prior to study, participants will be given complete information about the study procedure and all doubts regarding this study were clarified. Written informed consent will be obtained from each participant. Recruited patients will be admitted for Polysomnography within one month of recruitment. The patients shall be called after 6 months for PSG to see the effect of yoga. |