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CTRI Number  CTRI/2021/02/031466 [Registered on: 22/02/2021] Trial Registered Prospectively
Last Modified On: 19/02/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Other 
Public Title of Study   Yoga and sleep architecture in the elderly 
Scientific Title of Study   EFFICACY OF YOGA ON OBJECTIVE AND MECHANISTIC SLEEP MARKERS IN A GERIATRIC POPULATION – A LONGITUDINAL, SINGLE CASE STUDY 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SUDHA RAMAPRASAD 
Designation  PhD Scholar 
Affiliation  SVYASA Deemed University 
Address  Prashanti Kutiram, SVYASA Deemed-to-be University, Anekal Taluk, Jigani, Bengaluru - 560105
Prashanti Kutiram, Department of Life Sciences, Anveshana Laboratory, SVYASA Deemed-to-be University, Bengaluru - 560105
Bangalore
KARNATAKA
560105
India 
Phone  9448142819  
Fax    
Email  sudharamaprasad@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR MANJUNATH SHARMA N K 
Designation  Director Research 
Affiliation  SVYASA Deemed to be University 
Address  Prashanti Kutiram SVYASA Deemed to be University Anekal Taluk Jigani Bangalore
Prashanti Kutiram SVYASA Deemed to be University Anekal Taluk Jigani Bangalore 560105
Bangalore
KARNATAKA
560105
India 
Phone  9845037757  
Fax    
Email  nkmsharma@gmail.com  
 
Details of Contact Person
Public Query  
Name  SUDHA RAMAPRASAD 
Designation  PhD Scholar 
Affiliation  SVYASA Deemed University 
Address  Prashanti Kutiram, Department of Life Sciences, Anveshana Laboratory, SVYASA Deemed-to-be University, Anekal Taluk, Jigani, Bengaluru - 560105
Prashanti Kutiram, SVYASA Deemed-to-be University, Anekal Taluk, Jigani, Bengaluru - 560105
Bangalore
KARNATAKA
562123
India 
Phone  9448142819  
Fax    
Email  sudharamaprasad@gmail.com  
 
Source of Monetary or Material Support  
SVYASA Demmed to be University 
 
Primary Sponsor  
Name  SVYASA Deemed to be University 
Address  Prashanti Kutiram, Anekal Taluk, Jigani, Bangalore-560105 
Type of Sponsor  Other [University where the trial is proposed to be conducted] 
 
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 
SUDHA RAMAPRASAD  SVYASA Deemed-to-be University  Prashanti Kutiram, Department of Life Sciences, Anveshana Laboratory, Anekal Taluk, Jigani, Bangalore 560105
Bangalore
KARNATAKA 		 9448142819

sudharamaprasad@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy individuals between 60 years and 80 years of age 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Standardized Yoga Protocol  35 minutes session, five days a week for six months 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Healthy individuals above 60 years of age
2. Healthy individuals with normal age-related sleep disturbances
3. Individuals with minor health conditions which are under control by medication
4. Both Male and female
5. Volunteers only
 
 
ExclusionCriteria 
Details  1. Diagnosed with neuro-degenerative disorders such as Parkinson’s Disease, Alzheimer’s Disease, Dementia etc.
2. Individuals with chronic illness such as Cancer etc.
3. Severe co-morbidities such as un-controlled Diabetes and Hypertension
4. Severe arthritis or any other painful condition
5. Frail health (based on medical opinion)
6. Diagnosed mental illness including severe depression
7. Recent surgery or Fractures
8. Addictions including Caffeine
9. Use of Medications for Sleep disorders
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
• An understanding about changes in sleep architecture of the elderly population along with quality of life, following a yoga intervention, measured objectively using polysomnography
 		 5 time points
1. Baseline
2. End of 3rd month
3. End of 9th month
4. End of 15th month
5. End of 18th month 
 
Secondary Outcome  
Outcome  TimePoints 
• Generation of supportive evidence to understand the influence of the yoga intervention on the peripheral levels of the sleep regulatory cytokines with respect to the elderly population
• Correlation between Psychological outcomes measured through Geriatric Depression Scale, and Perceived Stress Scale and Quality of sleep following a yoga intervention
• A better Understanding of the Influence of compromised sleep quality on certain cognitive functions and its reversal through yoga
 		 19 time points
1. Baseline
2. End of 1st month
3. End of 2nd month
4. End of 3rd month
5. End of 4th month
6. End of 5th month
7. End of 6th month
8. End of 7th month
9. End of 8th month
10. End of 9th month
11. End of 10th month
12. End of 11th month
13. End of 12th month
14. End of 13th month
15. End of 14th month
16. End of 15th month
17. End of 16th month
18. End of 17th month
19. End of 18th month 
 
Target Sample Size   Total Sample Size="8"
Sample Size from India="8" 
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   N/A 
Date of First Enrollment (India)   24/02/2021 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

There is considerable research on sleep (Okano, Kaczmarzyk, Dave, Gabrieli, & Grossman, 2019), however, there is not much data on the objective measures of sleep together with yoga, especially in the elderly. Literature search has found this gap in the area of sleep research and the present study aims to fill this.

The uniqueness of the proposed research is a perspective using Polysomnography, considered a gold standard in sleep studies (Rundo & Downey, 2019), Inflammation markers (correlation between sleep and inflammation, noted through the effect on cytokines (inflammation markers) have been established (Besedovsky et al., 2019)) as well as certain subjective measures of sleep. This combined approach is different from and has not been observed in the extant studies on the influence of yoga on the sleep architecture in the elderly.

Yet another unique aspect is the design - single case experimental design (SCED). To make generalization possible, ergodic processing is necessary, i.e., a longitudinal study of a single sample with randomization of the process (Fisher, Medaglia, & Jeronimus, 2018). Most sleep studies measure sleep parameters for a single night to a few nights only; therefore, the long term consequences cannot be studied (Idesis, 2020). It is therefore, proposed to take up a detailed, long term, multiple time-point, single case experimental study approach, whereby it is hoped to gain insights that could potentially lead to improvement in the quality of life of the elderly.

 
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