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CTRI Number  CTRI/2026/01/101670 [Registered on: 20/01/2026] Trial Registered Prospectively
Last Modified On: 20/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   Comparison of vagus nerve stimulation exercises and aerobic exercises with CBT in people with sleep difficulty  
Scientific Title of Study   A Comparative Study To Evaluate The Effectiveness Of Vagus Nerve Stimulation Exercises And Aerobic Exercises On Heart Rate Variability And C- reactive Proteins Levels In Individuals With Secondary Insomnia 
Trial Acronym  VNS-HRV-CRP 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jagruti Sharma  
Designation  Postgraduate Student  
Affiliation  Jaipur National University  
Address  Department of Physiotherapy ,Jaipur National University, Jagatpura

Jaipur
RAJASTHAN
302017
India 
Phone  9967055989  
Fax    
Email  R52254.jagruti@jnujaipur.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Prof. Dr Ashutosh Sharma  
Designation  Professor 
Affiliation  Jaipur National University  
Address  Department of Physiotherapy ,Jaipur National University, Jagatpura

Jaipur
RAJASTHAN
302017
India 
Phone  9460108099  
Fax    
Email  drashutoshsharma@jnujaipur.ac.in   
 
Details of Contact Person
Public Query  
Name  Jagruti Sharma  
Designation  Postgraduate Student  
Affiliation  Jaipur National University  
Address  Department of Physiotherapy ,Jaipur National University, Jagatpura

Jaipur
RAJASTHAN
302017
India 
Phone  9967055989  
Fax    
Email  R52254.jagruti@jnujaipur.ac.in  
 
Source of Monetary or Material Support  
Neuro Rehabilitation OPD, Department of physiotherapy , Jaipur National University  
 
Primary Sponsor  
Name  Dr. Jagruti Sharma [PT] 
Address  Department Of Physiotherapy ,Jaipur National University ,Jagatpura -302017 
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 
Prof Dr Ashutosh Sharma  Jaipur National University Institute Of Medical Sciences And Research Centre   Neuro Rehabilitation OPD, Department of Physiotherapy, Jaipur National University Main Campus, Near RTO Office, Jagatpura, Jaipur, 302017
Jaipur
RAJASTHAN 		 94601108099

drashutoshsharma@jnujaipur.ac.in  
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F510||Insomnia not due to a substance orknown physiological condition,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Aerobic Exercise  static cycling- 5 mins one set jogging- 10mins jumping jacks-10reps with 2 sets skipping - 5minutes all the exercises done 4 times per week - total duration of intervention is 6 weeks 
Intervention  Vagus Nerve Stimulation Exercises  Manual Vagus Nerve Stimulation Exercises- 2 minutes of each exercise once a day and 4 times a day, Cognitive Behavioural Therapy- 30 minutes of counselling 4 times a week - total duration of intervention is 6 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  26.00 Year(s)
Gender  Both 
Details  All subjects with insomnia having a score of more than 5, which indicates poor sleep quality, according to Pittsburgh Sleep Quality Index (PSQI)
P-young individuals
I-vagus nerve stimulation exercise ,cognitive behavioral therapy, aerobic exercises
C-vagus nerve stimulation exercise and aerobic exercise
O –Heart rate variability, C-reactive protein , Pittsburgh sleep Quality Index
Secondary insomnia patients were included in the study who are having psychosomatic illness. eg. Anxiety

 
 
ExclusionCriteria 
Details  Subjects having any autoimmune condition , recent cold and cough, any inflammatory condition , sinusitis ,recent surgeries ,cardiac condition were excluded
Older adults and geriatric population were excluded
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
C- reactive protein levels
Heart rate variability  		 At day 0 and day 42 
 
Secondary Outcome  
Outcome  TimePoints 
Pittsburgh Sleep Quality Index   At day 0, day 21 and day 42  
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   01/02/2026 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - NO
Brief Summary   Insomnia is a prevalent sleep disorder associated with autonomic hyperarousal and inflammation, often reflected by altered heart rate variability (HRV) and elevated C-reactive protein (CRP). This 6-week randomised clinical trial aims to compare the effectiveness of manual vagus nerve stimulation exercises and aerobic exercises in individuals with secondary insomnia. Participants will be equally and randomly allocated, and outcomes will be measured using HRV, CRP levels, and the Pittsburgh Sleep Quality Index (PSQI) on day 0,21,42. 
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