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CTRI Number  CTRI/2024/09/074176 [Registered on: 23/09/2024] Trial Registered Prospectively
Last Modified On: 21/09/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Prevalence of Sleep Disorders, Academic Performance, and Sushupti Intervention: A Randomized Controlled Trial in the Undergraduate Students in Delhi, India 
Scientific Title of Study   Prevalence of Sleep Disorders, Associated Academic Performance and Sushupti Intervention: A Randomized Controlled Trial in the Undergraduate Students in Delhi, India 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Puneeta Ajmera 
Designation  Associate Professor 
Affiliation  Delhi Pharmaceutical Sciences and Research University 
Address  Room No. 403 C, 4th Floor, School of Allied Health Sciences and Management, Delhi Pharmaceutical Sciences & Research University
Mehrauli-Badarpur Road, Puspvihar, Sector 3, New Delhi-110017
South
DELHI
110017
India 
Phone  09990011377  
Fax    
Email  pajmera@dpsru.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Puneeta Ajmera 
Designation  Associate Professor 
Affiliation  Delhi Pharmaceutical Sciences and Research University 
Address  Room No. 403 C, 4th Floor. School of Allied Health Sciences & Management, Delhi Pharmaceutical Sciences & Research University
Mehrauli-Badarpur Road, Puspvihar, Sector 3, New Delhi-110017
South
DELHI
110017
India 
Phone  09990011377  
Fax    
Email  pajmera@dpsru.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Puneeta Ajmera 
Designation  Associate Professor 
Affiliation  Delhi Pharmaceutical Sciences and Research University 
Address  Room No. 403 C, 4th Floor, School of Allied Health Sciences & Management, Delhi Pharmaceutical Sciences & Research University
Mehrauli-Badarpur Road, Puspvihar, Sector 3, New Delhi-110017
South
DELHI
110017
India 
Phone  09990011377  
Fax    
Email  pajmera@dpsru.edu.in  
 
Source of Monetary or Material Support  
Delhi Pharmaceutical Sciences and Research University 
 
Primary Sponsor  
Name  Delhi Pharmaceutical Sciences and Research University 
Address  Mehrauli-Badarpur Road, Puspvihar, Sector 3, New Delhi-110017 
Type of Sponsor  Other [Government University] 
 
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 Puneeta Ajmera  Delhi Pharmaceutical Sciences and Research University  Department of Public Health, school of Allied Health Science & Management, Delhi Pharmaceutical Sciences & Research University, Mehrauli-Badarpur Road, Puspvihar, Sector 3, New Delhi-110017
South
DELHI 		 09990011377

puneeta_22@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Delhi Pharmaceutical Sciences and Research University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Poor Sleepers 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control Group with no treatment.  Control Group with no treatment. 
Intervention  Sushupti Intervention  “Sushupti” is a Sanskrit word which means “Deep Sleep”. It is a novel intervention and an integrated approach consisting of Mind Body Intervention (meditation, relaxation techniques, and breathing exercises), Yoga (Humming bee breath, the psychic breath, Wide-Knee Child’s pose, Crocodile Pose, Standing Forward Bend, Standing Half Forward Bend at the wall, Reclining Bound Angle, Legs Up The Wall Pose, and Corpse Pose), Yog Nidra, Pilates (One leg circle, Cat-Cow Stretch, One Hundred full, Double Leg Stretch, Shoulder Bridge, and The Saw), and an educational module. The trial will last for 12 weeks. The experimental group will receive the “Sushupti” Intervention program while no specific intervention will be given to the control group. For 12 weeks, intervention sessions will take place three times a week on alternate days. Each session will span for 60 minutes, divided into a 45-minute main session concentrating on the core elements of the intervention, and 15 minutes devoted to settling down, ensuring participant comfort, and integrating warm-up and cool-down activities. Initially, exercise sessions will start with a duration of 30 minutes, gradually progressing to 45 minutes. To assess the effectiveness of the intervention, the assessment will be done at baseline, 6-week mark, and after the completion of the Sushupti intervention i.e. 12 weeks.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  24.00 Year(s)
Gender  Both 
Details  Enrolled in any undergraduate course in an educational institute under the boundaries of National Capital, Delhi.
Understands English.
Provide consent to participate.
 
 
ExclusionCriteria 
Details  Student with any reported psychiatric disorder.
Do not understand English.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary outcome includes improvement in sleep latency, sleep duration, sleep efficiency, and sleep quality.  Baseline assessment (before initiation of intervention), intermediate assessment (at 6-weeks of intervention) and final assessment (at 12 weeks after completion of intervention). 
 
Secondary Outcome  
Outcome  TimePoints 
The secondary outcome includes raised knowledge and awareness of sleep and its significance for health and overall productivity.  Baseline assessment (before initiation of intervention), intermediate assessment (at 6-weeks of intervention) and final assessment (at 12 weeks after completion of intervention). 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" 
Phase of Trial   N/A 
Date of First Enrollment (India)   12/11/2024 
Date of Study Completion (India) 15/12/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
An innovative intervention titled "Sushupti Intervention" will be developed and validated for improving sleep quality. Sushupti is an integrated approach consisting of an education module related to sleep, components of Mind-body intervention, yoga, and Pilate exercises. The intervention will be implemented on students classified as poor sleepers according to the Pittsburgh Sleep Quality Index (PSQI). The sessions will be held three times a week over 12 weeks Baseline assessment (before initiation of intervention), intermediate assessment (at 6 weeks of intervention), and final assessment (after completion of intervention) will be conducted. A single-blinded Randomized Controlled Trial approach will be adopted to assess the efficacy of intervention on sleep among students. The assessment tools include pre- validated Harvard step test to examine cardiac fitness. Pittsburgh Sleep Quality Index (PSQI) to study sleep quality, Sleep Disorders Symptom Checklist (SDS-CL)-17 for examining the presence of symptoms of sleep disorder, and Menstrual Distress Questionnaire (MEDI-Q) to assess Menstrual distress among females. Lifestyle and screen time exposure assessment will be performed by using self- structured and validated tool.

 
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