| CTRI Number |
CTRI/2022/02/040092 [Registered on: 08/02/2022] Trial Registered Prospectively |
| Last Modified On: |
03/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assess daytime sleepiness, sleep quality and factors affecting sleep among students of professional colleges |
|
Scientific Title of Study
|
A study to assess daytime sleepiness, sleep quality and factors affecting sleep in view of developing an informational booklet on sleep hygiene among professional colleges of selected university in udupi district, karnataka |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tanuj Maithani |
| Designation |
M.Sc Nursing Student |
| Affiliation |
Manipal College of Nursing , Manipal Academy Of Higher Education, Manipal |
| Address |
Manipal College Of Nursing, Manipal Academy Of Higher Education Manipal, department of psychiatric health nursing, floor 6th, room no.604
Udupi
KARNATAKA
576104
India |
| Phone |
6396754691 |
| Fax |
|
| Email |
tanujmaithani02@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Savitha Prabhu |
| Designation |
Assistant professor |
| Affiliation |
Manipal College of Nursing , Manipal Academy Of Higher Education, Manipal |
| Address |
Manipal College Of Nursing, Manipal Academy Of Higher Education, Manipal, 6th floor, department of psychiatric health nursing, room no. 608
Udupi
KARNATAKA
576104
India |
| Phone |
9481760372 |
| Fax |
|
| Email |
savitha.umesh@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Miss Sanju Pant |
| Designation |
lecturer |
| Affiliation |
Manipal College of Nursing , Manipal Academy Of Higher Education, Manipal |
| Address |
Manipal College Of Nursing, Manipal Academy Of Higher Education, Manipal, 6th floor, Department of psychiatric health nursing, room no 601
Udupi
KARNATAKA
576104
India |
| Phone |
9991402789 |
| Fax |
|
| Email |
sanju.pant@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal College of Nursing, MAHE Manipal |
|
|
Primary Sponsor
|
| Name |
Tanuj Maithani |
| Address |
Manipal College of Nursing, MAHE, Manipal |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Tanuj Maithani |
Colleges of Manipal academy of higher education |
Manipal college of nursing, Manipal
Manipal college of pharmaceutical science, Manipal
Kasturba medical college, Manipal
Department of commerce, Manipal
Manipal school of architecture and planning, Manipal
Manipal center of business practice, Manipal
Manipal school of life sciences, Manipal
welcome group graduate school of hotel management, Manipal
Udupi
KARNATAKA |
6396754691
tanujmaithani02@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba medical college and kasturba hospital institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
To assess daytime sleepiness, factors affecting sleep and sleep quality of professional students from selected colleges |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
- students of professional colleges
- is studying in Manipal Academy of Higher Education
|
|
| ExclusionCriteria |
| Details |
- Students who are ill and on treatment.
- Not on any medication that induces sleep.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
- daytime sleepiness, factors affecting sleep and sleep quality
|
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| not applicable |
not applicable |
|
|
Target Sample Size
|
Total Sample Size="382"
Sample Size from India="382"
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)
|
10/02/2022 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The purpose of the study is to identify daytime sleepiness, factors affecting sleep and sleep quality among professional college students and helping them in maintaining quality of sleep by creating awareness on importance of sleep with relaxation techniques through a booklet which in turn might help them to improve sleep quality and perform their activities in a productive way. |