| CTRI Number |
CTRI/2025/03/083520 [Registered on: 26/03/2025] Trial Registered Prospectively |
| Last Modified On: |
25/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluating Sleep Quality and Its Effect on Health Symptoms and Academic Performance in School Students Aged 10-16 in Bhopal |
|
Scientific Title of Study
|
Assessment Of Sleep Quality And Its Impact On Arogya Lakshanas And Academic Performance Among School Students Of Age 10 To 16 Years In Bhopal -A Cross Sectional Study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sanjay Patel |
| Designation |
Post Graduate Scholar |
| Affiliation |
Pt.Khushilal Sharma Govt.(Autonomous) Ayurveda College and Institute,Bhopal |
| Address |
OPD No.8,Department of Swasthavritta and Yoga
Pt.Khushilal Sharma Govt.(Autonomous) Ayurveda College and Institute,Bhopal
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9685288129 |
| Fax |
|
| Email |
sp6865437@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nitin Marwaha |
| Designation |
Professor |
| Affiliation |
Pt.Khushilal Sharma Govt.(Autonomous) Ayurveda College and Institute,Bhopal |
| Address |
OPD No.8,Department of Swasthavritta and Yoga
Pt.Khushilal Sharma Govt.(Autonomous) Ayurveda College and Institute,Bhopal
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9425377177 |
| Fax |
|
| Email |
marwahaayu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nitin Marwaha |
| Designation |
Professor |
| Affiliation |
Pt.Khushilal Sharma Govt.(Autonomous) Ayurveda College and Institute,Bhopal |
| Address |
OPD No.8,Department of Swasthavritta and Yoga
Pt.Khushilal Sharma Govt.(Autonomous) Ayurveda College and Institute,Bhopal
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9425377177 |
| Fax |
|
| Email |
marwahaayu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt.Khushilal Sharma Govt.(Autonomous) Ayurveda College and Institute,Bhopal
MADHYA PRADESH
462003
India |
|
|
Primary Sponsor
|
| Name |
Pt.Khushilal Sharma Govt.(Autonomous) Ayurveda College and Institute,Bhopal |
| Address |
Science Hills, Nehru Nagar-Kolar Bypass Road, Bhopal,462003,M.P. |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sanjay Patel |
Pt.Khushilal Sharma Govt.(Autonomous) Ayurveda College and Institute,Bhopal |
OPD No.8, Department of Swasthavritta and Yoga,Science Hills, Nehru Nagar-Kolar Bypass Road, Bhopal,462003,M.P.
Bhopal
MADHYA PRADESH |
9685288129
sp6865437@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics CommitteePt.Khushilal Sharma Govt.(Autonomous) Ayurveda College and Institute,Bhopal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Assessment of sleep quality |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1.Participants between age group of 10 to 16 years of either gender irrespective of their
race, religion and cast.
2.Participants between class 6th to 10th and has at least studied in the school from last one year.
3.participants who are willing to join the survey study and have consent for the same. |
|
| ExclusionCriteria |
| Details |
Participants with epilepsy, cerebral palsy, muscular dystrophy, down syndrome or any
other severe systemic physical or mental disorder or have the parental history of major
psychiatric illness. |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
This study is expected to provide substantive data related to Quality of sleep and its impact on
Arogya lakshanas and academic performance in school going students of age 10 to 16 year in
Bhopal. |
08 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
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)
|
21/04/2025 |
| 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="8"
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 - NO
|
|
Brief Summary
|
Sleep is crucial for mental, physical, social, and emotional development. This study will be conducted as a cross-sectional observational study, with the sample selected using a stratified random sampling technique. Sleep quality will be assessed using the Pittsburgh Sleep Quality Index, and health symptoms will be evaluated according to Arogya Linga, as described by Acharya Kashyap. The target age group for this study will be school children aged 10 to 16 years of either gender, and the study duration will be 8 months. It is anticipated that this study will provide valuable insights into the sleep quality of school children in Bhopal city. |