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CTRI Number  CTRI/2017/05/008676 [Registered on: 26/05/2017] Trial Registered Prospectively
Last Modified On: 09/02/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy
Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Prevalence of sleep problems and role of sleep in sports 
Scientific Title of Study   Study the prevalence of sleep problems in young sportsperson and the role of individualized sleep prescriptions in improving performance 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Karuna Datta 
Designation  Professor 
Affiliation  Armed Forces Medical College 
Address  Department of Sports Medicine, Armed Forces Medical College, Pune

Pune
MAHARASHTRA
411040
India 
Phone  9560118881  
Fax    
Email  karunadatta@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Karuna Datta 
Designation  Professor 
Affiliation  Armed Forces Medical College 
Address  Department of Sports Medicine, Armed Forces Medical College, Pune

Pune
MAHARASHTRA
411040
India 
Phone  9560118881  
Fax    
Email  karunadatta@gmail.com  
 
Details of Contact Person
Public Query  
Name  Karuna Datta 
Designation  Professor 
Affiliation  Armed Forces Medical College 
Address  Department of Sports Medicine, Armed Forces Medical College, Pune

Pune
MAHARASHTRA
411040
India 
Phone  9560118881  
Fax    
Email  karunadatta@gmail.com  
 
Source of Monetary or Material Support  
Armed Forces Medical College Pune 411040 
 
Primary Sponsor  
Name  Armed Forces Medical College 
Address  Armed Forces Medical College Wanowrie Road, Pune 411040 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
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 
Karuna Datta  Armed Forces Medical College  Department of Sports Medicine, Armed Forces Medical College Pune 411040
Pune
MAHARASHTRA 		 9560118881

karunadatta@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Armed Forces Medical College Pune  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Sleep problems of poor sleep quality, sleep quantity or sleep onset latency,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cognitive and behavioural therapy, yoga nidra, apart from sleep education, sleep hygiene principles and self sleep monitoring using sleep diary  Apart from the methodology followed in the comparator group, these would also undergo behavioural modifications, cognitive restructuring and use of yoga nidra throughout the assessment period.  
Comparator Agent  Sleep education, self sleep monitoring using sleep diary and sleep hygiene principles  Sleep education would be taught.sleep hygiene principles would be taught and self sleep monitoring would be done using sleep diary. This would be done throughout the assessment period 
 
Inclusion Criteria  
Age From  14.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  Sportspersons following usual sleep wake and training schedule would be included. 
 
ExclusionCriteria 
Details  Sportsperson in the competition phase or trial phase for the competitions would be excluded.  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Performance in their sports and sleep diary parameters- time in bed, total sleep time, sleep onset latency, wake after sleep onset and sleep quality. PSG/Actigraphy parameters in case volunteer  Baseline,04 weeks of intervention 
 
Secondary Outcome  
Outcome  TimePoints 
Performance in their sports and sleep diary parameters- time in bed, total sleep time, sleep onset latency, wake after sleep onset and sleep quality  03 months of intervention- follow up 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   15/06/2017 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  

Introduction: Good sleep quality and better performance go hand in hand. It was initially felt that recovery is affected by reduced sleep quantity. Recent studies show that improvement of sleep latency, sleep quality and quantity do play an important role in improving performance as such. Often in competitive sports the sportsperson has change in living conditions, change in training schedules, and changes in optimum time required for performance due to shift in time for his event causing anxiety or an increased arousal which affects sleep quality and quantity both. Deterioration of sleep quality due to extraneous or internal factors has an individual susceptibility and can worsen his performance despite the best of training and support mechanisms. For better performance individually susceptible individuals should be trained to be able to preserve sleep to ensure best performance. Individualised sleep prescriptions (strictly non- pharmacological) is the way forward to solve this situation. The study is proposed to study the prevalence of sleep problems in young sportsperson and the role of individualized sleep prescriptions in improving performance.

Objectives:

To study the prevalence of sleep problems in sportsperson

To study the role of individualized sleep prescriptions in improving performance

 Methodology: 
  1. Identify the young sportsperson with individual susceptibility to sleep problems (method/ instrument used – school sleep habit survey form and two weeks sleep diary). The forms would be given to 12 – 18 years age and the data would be collected on an anonymous basis. This makes the reporting of the sleep problem better. Sleep diary would be used for sportsperson > 18 years of age. The sleep diary will be filled for two weeks.
  2.  Conduct an awareness talk which would make the sportsperson not only become aware about the sleep problem but also will motivate him to report and improve it. This also helps in enrolling sportsperson who are having sleep problems.
  3.  Use non pharmacological approach to improve sleep of the individually susceptible sportsperson. 
Cases with complaints of poor sleep quality, quantity or sleep latency after baseline assessment of sleep diary for two weeks would be randomised into two groups. All would be given basics of sleep awareness and education and told about sleep hygiene principles. Group I comparator group would be asked to write sleep diary and use it for self sleep monitoring understanding the various physiological factors which affect their sleep. Progressive muscular relaxation would be taught. Group II would be also give behavioural intervention, cognitive restructuring and other techniques like yoga nidra apart from progressive muscular relaxation.
Assessment would be done at four weeks of intervention and compared with baseline. Sleep diary parameters along with their performance at both time points would be recorded. Data thus obtained would be statistically analysed.

 Further Reading:

1. Reilly T, Edwards B. Altered sleep–wake cycles and physical performance in athletes. Physiol Behav. 2007;90(2–3):274–284.

2.  Robson-Ansley PJ, Gleeson M, Ansley L. Fatigue management in the preparation of Olympic athletes. J Sports Sci. 2009;27(13):1409–1420.

3. Samuels C. Sleep, recovery, and performance: the new frontier in high-performance athletics. Neurol Clin. 2008;26(1):169–180.

4. Leeder J, Glaister M, Pizzoferro K, et al. Sleep duration and quality in elite athletes measured using wristwatch actigraphy. J Sports Sci. 2012;30(6):541–545.

5. Erlacher D, Ehrlenspiel F, Adegbesan OA, et al. Sleep habits in German athletes before important competitions or games. J Sports Sci. 2011;29(8):859–866. 

6. Shapiro CM, Bortz R, Mitchell D, et al. Slow-wave sleep: a recovery period after exercise. Science. 1981;214(4526):1253–1254.

7. Dijk DJ. Slow-wave sleep deficiency and enhancement: implications for insomnia and its management. World J Biol Psychiatry. 2010

8. Mah CD, Mah KE, Kezirian EJ, et al. The effects of sleep extension on the athletic performance of collegiate basketball players. Sleep. 2011;34(7):943–950. 

9. Mah C (eds) Extended sleep and the effects on mood and athletic performance in collegiate swimmers. Annual Meeting of the Associated Professional Sleep Societies; 9 Jun 2008; Baltimore (MD).


 
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