| CTRI Number |
CTRI/2025/11/098144 [Registered on: 27/11/2025] Trial Registered Prospectively |
| Last Modified On: |
26/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study on how sleep and stress affect memory and attention in university students |
|
Scientific Title of Study
|
Sleep Quality, Stress and their Combined Effect on Cognitive Function among University Students- 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 |
Palak Sehgal |
| Designation |
Student |
| Affiliation |
DoPT, Amity Institute of Health Allied Sciences |
| Address |
Amity University, noida sector 125, uttar pradesh 201313
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
9650545052 |
| Fax |
|
| Email |
palaksehgal7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chandan Kumar |
| Designation |
Professor |
| Affiliation |
DoPT, Amity Institute of Health Allied Sciences |
| Address |
Amity University, noida sector 125, uttar pradesh 201313
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
7773923831 |
| Fax |
|
| Email |
ckumar1@amity.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chandan Kumar |
| Designation |
Professor |
| Affiliation |
DoPT, Amity Institute of Health Allied Sciences |
| Address |
Amity University, noida sector 125, uttar pradesh 201313
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
7773923831 |
| Fax |
|
| Email |
ckumar1@amity.edu |
|
|
Source of Monetary or Material Support
|
| DoPT, Amity Institute of Health Allied Sciences, F1, LGF, Amity University, sector 125, Noida, Uttar Pradesh, 201313, India |
|
|
Primary Sponsor
|
| Name |
DoPT, Amity Institute of Health Allied Sciences, Amity University |
| Address |
Sector- 125, Noida, Uttar Pradesh, 201313, India |
| Type of Sponsor |
Other [Educational University ] |
|
|
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 Chandan Kumar |
Amity University |
Amity Institute of Health Allied Sciences (AIHAS) F 1 Block, LGF, Sector-125, Noida-201303, India. Sector-125, Amity University NOIDA (UP)-201301, INDIA
Gautam Buddha Nagar
UTTAR PRADESH |
7773923831
ckumar1@amity.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional NTCC committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Universty Students |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NILL |
NILL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
26.00 Year(s) |
| Gender |
Both |
| Details |
Participants for this study will consist of undergraduate and postgraduate students. The study includes participants aged 18 to 26 years studying at universities or colleges in the Delhi NCR area. Students who volunteer to participate and are able to understand English will be included.
|
|
| ExclusionCriteria |
| Details |
Participants diagnosed with any neurological illness including epilepsy, stroke, or traumatic brain injury.
Participants with a history of psychiatric illness such as schizophrenia or bipolar disorder.
Participants diagnosed with sleep disorders such as primary insomnia, sleep apnea, or narcolepsy, and those taking medications that affect cognition or sleep such as sedatives, antidepressants, or stimulants.
Participants with visual or hearing impairments or any cognitive disturbances that may interfere with cognitive testing.A |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Cognitive function measured using the Montreal Cognitive Assessment (MoCA)
Pittsburgh Sleep Quality Index (PSQI)
Perceived Stress Scale (PSS) |
One time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NILL |
NILL |
|
|
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)
|
08/12/2025 |
| 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="5"
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
|
This cross-sectional observational study aims to assess the relationship between sleep quality, perceived stress, and cognitive function among university students aged 18–26 years in the Delhi-NCR region. Poor sleep quality and high stress levels are frequently reported among young adults and are known to impact cognitive domains such as attention, memory, and executive functioning. However, limited research has examined their combined or interaction effect on cognition in Indian university populations.
A total of 400 students will be recruited through convenience sampling. Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), stress will be measured using the Perceived Stress Scale (PSS-10), and cognitive function will be evaluated using the Montreal Cognitive Assessment (MoCA). Additional variables including gender, screen time, and physical activity (IPAQ-SF) will also be recorded.
Data will be collected through offline, face-to-face administration of questionnaires following informed consent. Statistical analysis will include descriptive statistics, Pearson’s correlation, independent t-tests for gender differences, and multiple regression to evaluate the predictive and interaction effects of sleep quality and stress on cognition, while adjusting for covariates.
The study aims to generate evidence regarding how sleep and stress jointly influence cognitive performance in university students, which may help inform campus-based mental health strategies, academic support programs, and lifestyle interventions. |