| CTRI Number |
CTRI/2025/10/096198 [Registered on: 21/10/2025] Trial Registered Prospectively |
| Last Modified On: |
15/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
How Sleep Quality Affects Thinking Skills, Physical Performance, and School Grades in High School Students |
|
Scientific Title of Study
|
Correlation of sleep quality with executive function, agility, reaction time and academic performance in high school students |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pallavi Mahto |
| Designation |
Postgraduate Student |
| Affiliation |
Amar Jyoti Institute of Physiotherapy Karkardooma, Vikas Marg, Delhi 110092 |
| Address |
Amar Jyoti Institute of Physiotherapy, Neurology Research Laboratory, Third Floor, Karkardooma, Vikas Marg, Delhi 110092
East DELHI 110092 India |
| Phone |
8920886760 |
| Fax |
|
| Email |
pallavioct2001@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Preksha Sharma PT |
| Designation |
Assistant Professor |
| Affiliation |
Amar Jyoti Institute of Physiotherapy Karkardooma, Vikas Marg, Delhi 110092 |
| Address |
Amar Jyoti Institute of Physiotherapy, Neurology Research Laboratory, Third Floor, Karkardooma, Vikas Marg, Delhi 110092
East DELHI 110092 India |
| Phone |
9990640376 |
| Fax |
|
| Email |
prekshas059@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Preksha Sharma PT |
| Designation |
Assistant Professor |
| Affiliation |
Amar Jyoti Institute of Physiotherapy Karkardooma, Vikas Marg, Delhi 110092 |
| Address |
Amar Jyoti Institute of Physiotherapy, Neurology Research Laboratory, Third Floor, Karkardooma, Vikas Marg, Delhi 110092
East DELHI 110092 India |
| Phone |
9990640376 |
| Fax |
|
| Email |
prekshas059@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajkiya Sarvodaya Bal Vidyalaya, West Vinod Nagar, Delhi- 110092 |
| Rajkiya Sarvodaya Kanya Vidyalaya, West Vinod Nagar, Delhi- 110092 |
|
|
Primary Sponsor
|
| Name |
Pallavi Mahto |
| Address |
Amar Jyoti Institute of Physiotherapy Karkardooma, Vikas Marg, Delhi 110092 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Pallavi Mahto |
Rajkiya Sarvodaya Bal Vidyalaya |
West Vinod Nagar, Delhi-110092 East DELHI |
8920886760
pallavioct2001@gmail.com |
| Pallavi Mahto |
Rajkiya Sarvodaya Kanya Vidyalaya |
West Vinod Nagar, Delhi-110092 East DELHI |
8920886760
pallavioct2001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Amar Jyoti Institutional Review Board-Ethical Committee |
Approved |
| Rajkiya Sarvodaya Bal Vidyalaya |
No Objection Certificate |
| Rajkiya Sarvodaya Kanya Vidyalaya |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal Healthy Volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Participants able to easily write and read in English. |
|
| ExclusionCriteria |
| Details |
1. Subjects with psychiatric, neurological, endocrinological and cardiovascular problems.
2. Subjects with any history of alcohol, nicotine use within last three months.
3. Subjects with any history or current use of narcotics and psychiatric medications.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Pittsburgh Sleep Quality Index (PSQI)
2.Trail Making Test (TMT) Parts A and B
3. T Test
4. Audio Visual Reaction Time Machine
|
Baseline Assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="138" Sample Size from India="138"
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)
|
11/11/2025 |
| 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="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
|
The primary purpose of this study is to comprehensively examine how sleep quality is associated with various cognitive, physical, and academic outcomes in high school students. Specifically, the study aims to explore the correlation between sleep quality and (1) executive function, which encompasses attention, cognitive flexibility, planning, and problem-solving abilities; (2) reaction time, which reflects the speed and efficiency of processing and responding to stimuli; (3) agility, which represents physical coordination, quickness, and motor control; and (4) academic performance, which indicates a student’s scholastic achievement and learning outcomes.
Given the critical role of sleep in adolescent development, this research seeks to generate evidence on whether better sleep quality is predictive of superior cognitive performance, faster reaction times, better agility, and improved academic results. The findings may provide valuable insights to educators, parents, and policymakers for designing interventions and school-based programs to promote sleep hygiene, reduce academic stress, and optimize student health and performance.
Null Hypothesis- There is no correlation between sleep quality and executive function, agility, reaction time and academic performance in high school students. Alternate Hypothesis- There is correlation between sleep quality and executive function, agility, reaction time and academic performance in high school students. |