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CTRI Number  CTRI/2024/03/064731 [Registered on: 26/03/2024] Trial Registered Prospectively
Last Modified On: 21/03/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy
Other (Specify) [Insomnia during menopause]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Yoga Nidra for management of post menopausal insomnia 
Scientific Title of Study   Neural correlates of Yoga Nidra for management of insomnia in peri-menopausal women  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kamalesh K Gulia 
Designation  Scientist G 
Affiliation  Sree Chitra Tirunal Institute for Medical Sciences and Technology Trivandrum 
Address  Room no. G-191, Division of Sleep Research, Department of Applied Biology, Biomedical Technology wing Poojappura, Sree Chitra Tirunal Institute for Medical Sciences and Technology Trivandrum

Thiruvananthapuram
KERALA
695012
India 
Phone  9048344712  
Fax  914712341814  
Email  kkgulia@sctimst.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Kamalesh K Gulia 
Designation  Scientist G 
Affiliation  Sree Chitra Tirunal Institute for Medical Sciences and Technology Trivandrum 
Address  Room no- G191, Division of Sleep Research,Department of Applied Biology, Biomedical Technology wing Poojappura, Sree Chitra Tirunal Institute for Medical Sciences and Technology Trivandrum

Thiruvananthapuram
KERALA
695012
India 
Phone  9048344712  
Fax  914712341814  
Email  kkgulia@sctimst.ac.in  
 
Details of Contact Person
Public Query  
Name  Kamalesh K Gulia 
Designation  Scientist G 
Affiliation  Sree Chitra Tirunal Institute for Medical Sciences and Technology Trivandrum 
Address  G-191, Division of Sleep Research, Department of Applied Biology Biomedical Technology wing Poojappura, Sree Chitra Tirunal Institute for Medical Sciences and Technology Trivandrum

Thiruvananthapuram
KERALA
695012
India 
Phone  9048344712  
Fax  914712341814  
Email  kkgulia@sctimst.ac.in  
 
Source of Monetary or Material Support  
Department of Science and Technology, Delhi from WISE KIRAN Division 
 
Primary Sponsor  
Name  Department of Science and Technology, Delhi 
Address  Ministry of Science and Technology Department of Science and Technology Technology Bhavan New Delhi  
Type of Sponsor  Government funding agency 
 
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 
Dr Kamalesh K Gulia  Sree Chitra Tirunal Institute for Medical Sciences and Technology  Division of Sleep Research Biomedical Technology wing Trivandrum
Thiruvananthapuram
KERALA 		 9048344712

kkgulia@sctimst.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC SCTIMST  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G||Mental Health,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Control  No Yoga/ No Yoga Nidra intervention in this group 
Intervention  Yoga Nidra techniques for 24 weeks (Group 1) Yoga protocol for insomnia   Yoga Nidra protocol developed by Bihar School of yoga by Swami Satyananda Saraswati will be used for 24 weeks. Yoga for insomnia protocol developed by NIMHANS by Department of integrative Medicine will be used for period of 24 weeks  
Comparator Agent  Yoga protocol  Yoga for insomnia developed by NIMHANS Bangalore by Department of Integrative Medicine 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  In this trial, we propose to address postmenopausal insomnia in women by using Yoga Nidra as a non-pharmacological therapeutic tool in achieving good quality sleep and to get control on emotional and cognitive states for improving an overall wellbeing in a cozy home setup. YogaNidra is a powerful technique known to reduce stress, anxiety and to attain self-control. There are no randomized controlled trial studies (RCT) on Yoga Nidra to alleviate the insomnia associated with the menopausal changes in women.
Inclusion Criterion: In first part, a gross questionnaire (Sleep Health Index by National Sleep Foundation, US) based national survey will be undertaken for women above 45 years of age to 65 years without any criterion of health condition. This will provide us a prevalence of insomnia in this age bracket.

In next step, Women in age group above 45 years undergoing or completed menopause only) will be selected through randomization process for intervention study in three groups. One would be without Yoga, one with Yoga (protocol provided by NIMHANS for insomnia) and 3rd group in YogaNidra. In each group, we will have objective measures in limited numbers of participants. 
 
ExclusionCriteria 
Details  Women with history of neuro-psychiatric diseases, hypertension, cardiovascular, diabetic, cancer or arthritis problems

Women below 45 years and above 65 years 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
As the life expectancy is women is a few years longer than the men, to sustain healthy postmenopausal life which is about one third of their life (20-30 years), the technique of YogaNidra will help the participants to"
1. improve their sleep
2. to improve quality of life and wellbeing.
3. To provide evidences on mechanism of action of YogaNidra through objective measures
4. To increase productivity at home and social networks through their experience of life.  		 i. In first nine month, questionnaire based survey will be completed
2. The recruitment of participants for objective measures (EEG based evaluation ) will start after CTRI registration, from May 2024. The pretreatment time is 4 weeks, and treatment with yoga is 24 weeks for which the EEG based assessment will be carried out at 4 weeks, 16 weeks and 24 weeks
3. The Recruitment of participants for the subjective assessment will begin by June 2024  
 
Secondary Outcome  
Outcome  TimePoints 
Secondary outcomes will be related physical health  6 months 
 
Target Sample Size   Total Sample Size="3000"
Sample Size from India="3000" 
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)   01/04/2024 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response (Others) -  Govt agencies involved in policy making decisions

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  On the D space of the institute

  6. For how long will this data be available start date provided 15-05-2026 and end date provided 14-05-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  
This clinical trial study involves using non-pharmacological therapeutic intervention of Yoga Nidra to address post-menopausal insomnia in achieving good quality sleep and to get control on emotional and cognitive states to improve overall well being in cozy home setup. We will also provide evidences for the mechanism of action of Yoga Nidra based on EEG, ECG parameter drive brain and autonomic states.

We will begin with questionnaire based screening of women in range of 45 to 65 years) using Sleep Health Index to have prevalence of insomnia in this age group. About 135 participants from Trivandrum zone will be selected for the objective measurement that will be based on actigraphy and EEG and ECG based assessment of health before Yoga or Yoga Nidra intervention of 24 weeks in insomniac postmenopausal women.  We will be able to provide the neural correlates of Yoga Nidra  to understand how this technique helps in improving the brain and thus well being.
 
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