| CTRI Number |
CTRI/2013/05/003682 [Registered on: 27/05/2013] Trial Registered Retrospectively |
| Last Modified On: |
08/05/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Electrophysiological characterisation of yoga nidra and its role in Insomnia ( sleeplessness)patients |
|
Scientific Title of Study
|
Electrophysiological characterisation of yoga nidra and its role in insomnia patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IESC/T-394/2012 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Lt Col Dr Karuna Datta |
| Designation |
PhD student |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Physiology
All India Institute of Medical Sciences
New Delhi- 29
New Delhi
DELHI
110029
India |
| Phone |
011-26594623 |
| Fax |
|
| Email |
karunadatta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjari Tripathi |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Neurology
All India Institute of Medical Sciences
Ansari Nagar
New Delhi
New Delhi
DELHI
110029
India |
| Phone |
011-26594494 |
| Fax |
|
| Email |
manjari.tripathi1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr HN Mallick |
| Designation |
Professor |
| Affiliation |
AIIMS |
| Address |
Room Number 2003
Department of Physiology
AIIMS
Ansari Nagar
New Delhi
South
DELHI
110029
India |
| Phone |
011-26594881 |
| Fax |
|
| Email |
drhmallick@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Department of Physiology
New Delhi
110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Lt Col Dr Karuna Datta |
AIIMS |
Room No. 2028, Department of Physiology, All India Institute of Medical Sciences, New Delhi
New Delhi
DELHI |
011-26594623
karunadatta@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS |
Approved |
| Last DSMB meeting report |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Electrophysiological characterisation of yoga nidra would be done on healthy subjects |
| Patients |
Insomnia ( to study the role of yoga nidra in insomnia patients), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group I (Healthy subjects) |
The group I would be studied for electrophysiological characterisation of yoga nidra where healthy subjects would be studied. Baseline electrophysiological monitoring of these subjects using EEG, EOG and EMG would be done. After this, the subjects would be trained in yoga nidra for 4 weeks and electrophysiological monitoring would be repeated at the end of four weeks. The baseline monitoring would be compared with the electrophysiological monitoring obtained after 4 weeks.
Yoga nidra training would be supervised for the first five days at the departement. Each session would be of half an hour duration and after five days of supervised sessions the subject would do the training on his own for a total duration of 4 weeks.The training session is done by a simple to follow pre- recorded CD which would be given to patient after five days of traing. |
| Comparator Agent |
Group II ( insomnia patients) subgroup A-Standard treatment |
The comparator group would consist of insomnia patients and they also would be studied after four weeks using standard treatment. The standard treatment in the form of Cognitive Behavioural Therapy (CBT) for insomnia would be done in a total of six sessions in four weeks by a CBT trained person.Their treatment as prescribed by the doctor would also continue during the study. |
| Intervention |
Group II ( insomnia patients) subgroup B- Yoga Nidra |
The intervention group would consist of insomnia patients and they would be given yoga nidra training for four weeks. Their conventional treatment as prescribed by the doctor would not be stopped during the study. Yoga nidra training would be supervised for first five days at the department daily. Each session would be for half an hour and after five supervised sessions, the patient would do this training session on his own for four weeks total duration. The training session would be done by a simple to follow pre-recorded CD which would be also given to the patient after the first five days of training. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Group I
Healthy subjects willing to participate in the study would be recruited. They should be following usual wake sleep schedule.
Group II
Patients should be following usual sleep wake schedule during the study period. They should be symptomatic for atleast six months. They should be having atleast one sleep symptom and one wake symptom for diagnosis of insomnia . Sleep symptom of difficulty initiating/ maintaining sleep/ early morning awakening or non restorative or non refreshing sleep, or combination of these sleep symptoms. Wake symptom comprising of sleep associated day time impairment e.g. sleepiness, fatigue, mood disturbances, cognitive difficulties, social impairment or occupational impairment. |
|
| ExclusionCriteria |
| Details |
History of any acute illness in the preceding one month which is likely to cause sleep disturbance would be considered exclusion criteria. Insomnia patients with symptoms for less than six months would be excluded from the study. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Group I
Electrophysiological monitoring using EEG, EMG, EOG,
Pre Sleep Arousal Scale
Salivary Cortisol
Group II Overnight Polysomnography
Insomnia severity index
Pittsburgh Sleep Quality Index
Pre Sleep Arousal Scale
Salivary Cortisol |
Baseline and after 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Group II- Insomnia severity index
Pre Sleep Arousal Scale
Salivary Cortisol |
2 weeks |
| Group I- Pre sleep arousal scale, salivary cortisol |
2 weeks |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/02/2013 |
| Date of Study Completion (India) |
22/02/2015 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
22/02/2015 |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Yoga Nidra: An innovative approach for management of chronic insomnia-A case report
K Datta, M Tripathi, HN Mallick - Sleep Science and Practice, 2017 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The study is a PhD thesis work which would be to do electrophysiological characterisation of yoga nidra and to study its role in insomnia patients. Introduction- According to ancient literature, yoga nidra is also called yogic sleep. Yoga nidra has been used in some diseases eg. Diabetes mellitus, post traumatic stress disorder, patients with menstrual abnormality, anxiety and depression. Although there is a mention of yoga nidra in ancient literature and it has been used for diseases, but no literature is available on its electrophysiological characterisation and its role in sleep disorders. This study aims to study its role in insomnia patients. Material and Methods-The study would be done in two groups- group I would be done on 30 healthy subjects where electrophysiological monitoring while doing yoga nidra training after 4 weeks of training and would be compared to baseline at the same time of the day. Pre sleep arousal scale and salivary cortisol would be collected at baseline and after 4 weeks. This would be a longitudinal study design. Group II would be to study the role of yoga nidra in insomnia patients in a randomised control design. This would be done on 60 insomnia patients randomly divided into two subgroups consisting of 30 patients each in each subgroup- Subgroup A and Subgroup B. Subgroup A would be treated with conventional treatment and subgroup B would be treated with conventional treatment and yoga nidra. Patients would be offered overnight polysomnography before and after the intervention. They would also complete questionnaires assessing their sleep quality, and those monitoring treatment outcomes. Salivary estimation of cortisol would be done during the course of the intervention. The data collected would be analysed using statistical measures. |