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CTRI Number  CTRI/2013/05/003682 [Registered on: 27/05/2013] Trial Registered Retrospectively
Last Modified On: 14/12/2016
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 
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  
Nil 
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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" 
Phase of Trial   N/A 
Date of First Enrollment (India)   28/02/2013 
Date of First Enrollment (Global)  No Date Specified 
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   None 
Brief Summary  

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.

 
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