| CTRI Number |
CTRI/2026/01/101155 [Registered on: 14/01/2026] Trial Registered Prospectively |
| Last Modified On: |
13/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of a Structured Sleep Protocol in Enhancing Sleep Quality Among Archers |
|
Scientific Title of Study
|
Effectiveness of a structured sleep protocol on quality of sleep among archery athletes |
| Trial Acronym |
Effectiveness of a Structured Sleep Protocol On Sleep Quality Among Archery Athletes a Randomised Controlled Trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arushi Saxena |
| Designation |
Assistant Professor |
| Affiliation |
Jaipur National University |
| Address |
Near New RTO Office, Jagatpura, Jaipur Department of Physiotherapy division sports and orthopedics,Room 02 Jaipur Rajasthan
Jaipur
RAJASTHAN
302017
India |
| Phone |
9664389674 |
| Fax |
|
| Email |
arushi.saxena@jnujaipur.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Arushi Saxena |
| Designation |
Assistant Professor |
| Affiliation |
Jaipur National University |
| Address |
Near New RTO Office, Jagatpura, Jaipur Department of Physiotherapy division sports and orthopedics,Room 02 Jaipur Rajasthan
Jaipur
RAJASTHAN
302017
India |
| Phone |
9664389674 |
| Fax |
|
| Email |
arushi.saxena@jnujaipur.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Arushi Saxena |
| Designation |
Assistant Professor |
| Affiliation |
Jaipur National University |
| Address |
Near New RTO Office, Jagatpura, Jaipur Department of Physiotherapy division sports and orthopedics,Room 02 Jaipur Rajasthan
Jaipur
RAJASTHAN
302017
India |
| Phone |
9664389674 |
| Fax |
|
| Email |
arushi.saxena@jnujaipur.ac.in |
|
|
Source of Monetary or Material Support
|
| Near New RTO Office Jagatpura Jaipur Department of Physiotherapy division sports and orthopaedic room 02 jaipur rajasthan 302017 |
|
|
Primary Sponsor
|
| Name |
Jaipur National University |
| Address |
Near New RTO Office, Jagatpura, Jaipur Department of Physiotherapy division sports and orthopedics,Room 02 Jaipur Rajasthan |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| jaipur national university |
jaipur national university |
| NIL |
NIL |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anam Gaur |
jaipur national unversity |
Near New RTO Office, Jagatpura, Jaipur department of physiotherapy division- sports and orthopedics, room 02
Jaipur
RAJASTHAN
Jaipur
RAJASTHAN |
9351918199
anamgaur567@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JAIPUR NATIONAL UNIVERSITY INSTUTUTE FOR MEDICAL SCIENCESAND RESEARCH CENTER, JAIPUR INSTUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F489||Nonpsychotic mental disorder, unspecified, (2) ICD-10 Condition: F489||Nonpsychotic mental disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A |
Structure Sleep Protocol |
| Comparator Agent |
Group B |
Coventional Therapy |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Athletes aged between 18 to 30 years. 82.
National or state-level competitive archery athletes with minimum 2 years of professional training experience.93.
Individuals with regular sleep schedules (±1 hour bedtime/wake time) for the past 1 month, as verified by a 7-day actigraphy or sleep diary. |
|
| ExclusionCriteria |
| Details |
Diagnosed sleep disorders (eg insomnia, sleep apnea) or those with Pittsburgh Sleep Quality Index (PSQI) 14 indicating severe sleep disturbances
Use of alcohol or nicotine within 6 hours before bedtime or habitual use of sleep medications or stimulants in the past 3 months
Current or past history of clinical depression, anxiety disorders, epilepsy, or other neurological impairments affecting sleep or cognitive functioning
Participation in any other interventional or sleep-related study within the last 3 months to avoid confounding effects |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
SQS
PSQI
ISI |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
SQS
PSQI
ISI |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
26/02/2026 |
| 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="1"
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
|
Sports rehabilitation to improve the quality of sleep among the Archery Athletes a structured sleep protocol will help them to improve there quality of sleep |