| CTRI Number |
CTRI/2023/03/050466 [Registered on: 07/03/2023] Trial Registered Prospectively |
| Last Modified On: |
04/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Correlational study |
| Study Design |
Other |
|
Public Title of Study
|
Relationship of chronotype with sleep and anxiety in collegiate athletes.
|
|
Scientific Title of Study
|
Correlation of chronotype with sleep and anxiety among collegiate athletes. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Moazzam Hussain Khan PT |
| Designation |
Assistant Professor Sports Medicine |
| Affiliation |
ASSISTANT PROFESSOR SPORTS MEDICINE |
| Address |
Room 112, First floor, Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia University Delhi
New Delhi
DELHI
110025
India |
| Phone |
|
| Fax |
|
| Email |
mkhan47@jmi.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Moazzam Hussain Khan PT |
| Designation |
Assistant Professor Sports Medicine |
| Affiliation |
ASSISTANT PROFESSOR SPORTS MEDICINE |
| Address |
Room 112 First floor Centre for Physiotherapy and Rehabilitation Sciences Jamia Millia Islamia University Delhi
New Delhi
DELHI
110025
India |
| Phone |
|
| Fax |
|
| Email |
mkhan47@jmi.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Moazzam Hussain Khan PT |
| Designation |
Assistant Professor Sports Medicine |
| Affiliation |
ASSISTANT PROFESSOR SPORTS MEDICINE |
| Address |
Room 112 First floor Centre for Physiotherapy and Rehabilitation Sciences Jamia Millia Islamia University Delhi
New Delhi
DELHI
110025
India |
| Phone |
|
| Fax |
|
| Email |
mkhan47@jmi.ac.in |
|
|
Source of Monetary or Material Support
|
| Nawab Mansoor Ali Khan Pataudi Sports Complex, Jamia Millia Islamia University, Jamia Nagar, Okhla, Delhi 110025 |
|
|
Primary Sponsor
|
| Name |
Centre for Physiotherapy and Rehabilitation Sciences Jamia Millia Islamia University |
| Address |
Jamia Millia Islamia University Jamia Nagar, Okhla, New Delhi, Delhi 110025 |
| Type of Sponsor |
Other [Central Government 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 |
| Kamini Sharma |
, Centre for Physiotherapy and Rehabilitation Sciences Jamia Millia Islamia University |
Human performance lab, first floor, Jamia Millia Islamia University, Jamia Nagar,Okhla,Delhi 110025
New Delhi
DELHI |
8826586469
kaminisharma708@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Jamia Millia Islamia |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy male and female collegiate athletes of 18-25 years |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
a. Healthy male and female collegiate athletes between 18-25 years.
b. Enrolled in university and participate in any one individual or team sport.
c. regularly practicing and competing in organized sports.
d. Able to comprehend and write English |
|
| ExclusionCriteria |
| Details |
Performing ≤3 planned exercise training sessions per week
b. History of concussion and related symptoms.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To find the correlation of chronotype with sleep in collegiate athletes.
2. To find out the correlation of chronotype with anxiety among collegiate athletes. |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study correlation of chronotype with sleep and anxiety among collegiate athletes at 4 weeks |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="199"
Sample Size from India="199"
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)
|
09/03/2023 |
| 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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
1. The study aims to find the correlation of chronotype with sleep and anxiety among collegiate athletes. 2. Positive results of the study will be helpful in pre participation evaluation of collegiate athletes. 3. Sleep and anxiety affects athletic performance.So, athlete found to be affected from sleep and anxiety will be aided through management. 4. The study is one time correlational study which uses two questionnaires which will take approximately 15-20 minutes. |