| CTRI Number |
CTRI/2025/02/079882 [Registered on: 03/02/2025] Trial Registered Prospectively |
| Last Modified On: |
27/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluating sleep disturbances among college medical students involves using two specific tools: the Epworth Sleepiness Scale and the STOP-Bang Questionnaire. |
|
Scientific Title of Study
|
Evaluating sleep disturbance among undergraduate medical students using the Epworth Sleepiness Scale and STOP BANG questionnaire |
| 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. Basavaraj Motimath |
| Designation |
Professor and HOD of department of Sports Physiotherapy |
| Affiliation |
KLE Institute of Physiotherapy |
| Address |
KLE Institute of Physiotherapy, JNMC Campus, Nehru Nagar, Belagavi, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9886100461 |
| Fax |
|
| Email |
basavarajmotimath@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Basavaraj Motimath |
| Designation |
Professor and HOD of department of Sports Physiotherapy |
| Affiliation |
KLE Institute of Physiotherapy |
| Address |
Advanced Physiotherapy Centre, OPD No.39, Department of Sports Physiotherapy, Room No. 08, Sagar Floor, KLEs Dr.Prabhakar Kore Hospital and MRC, Nehru Nagar, Belagavi,Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9886100461 |
| Fax |
|
| Email |
basavarajmotimath@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shreenidhi Lambe |
| Designation |
Physiotherapy Intern |
| Affiliation |
KLE Institute of Physiotherapy |
| Address |
Advanced Physiotherapy Centre, OPD No.39, Department of Sports Physiotherapy, Room No. 08, Sagar Floor, KLEs Dr.Prabhakar Kore Hospital and MRC, Nehru Nagar, Belagavi,Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9637509069 |
| Fax |
|
| Email |
shreenidhi1211@gmail.com |
|
|
Source of Monetary or Material Support
|
| Constituents Medical Units of KAHER University, Belagavi City, Karnataka, India-590010 |
|
|
Primary Sponsor
|
| Name |
KAHER Institute of Physiotherapy |
| Address |
Advanced Physiotherapy Centre, OPD No.39, Department of Sports Physiotherapy, Room No. 08, Sagar Floor, KLEs Dr.Prabhakar Kore Hospital and MRC, Nehru Nagar, Belagavi,Karnataka |
| Type of Sponsor |
Other [Self sponsored] |
|
|
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 Basavaraj Motimath |
KLEs Dr. Prabhakar Kore Hospital & Medical Research Centre |
Sports Physiotherapy department
Room no. 39
Belgaum
KARNATAKA |
9886100461
basavarajmotimath@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rresearch and Ethical Committee,KLEU Institute of Physiotherapy, Belagavi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Students with sleep disorder |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
24.00 Year(s) |
| Gender |
Both |
| Details |
The study will include both male and female participants between the age group of 18 to 24 years. |
|
| ExclusionCriteria |
| Details |
Students unwilling to participate. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
OBJECTIVE FOR THE STUDY:
To evaluate the prevalence of sleep disturbance among college students by using The Epworth Sleepiness Scale (ESS) and STOP-BANG Sleep Apnea Questionnaire.
|
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
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)
|
03/02/2025 |
| 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 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
|
AIM FOR THE STUDY To evaluate the prevalence of sleep disturbance among college students
OBJECTIVE FOR THE STUDY: To evaluate the prevalence of sleep disturbance among college students by using The Epworth Sleepiness Scale (ESS) and STOP-BANG Sleep Apnea Questionnaire.
INCLUSION CRITERIA The study will include both male and female participants between the ages of 18 to 24 years.
EXCLUSION CRITERIA · Students unwilling to participate.
This research will identify the scope of sleep disturbances, can guide the development of targeted strategies and support system within the medical education, promoting healthier lifestyle and enhancing academic success. The need for the study arises due to dearth of literature on prevalence of sleep disturbance in college going students.
|