Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000257763
Ethics application status
Approved
Date submitted
19/02/2013
Date registered
5/03/2013
Date last updated
5/03/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
A novel sleep extension and optimisation program to decrease daytime sleepiness and improve athletic performance in a group of elite athletes
Scientific title
A sleep extension and optimisation program to decrease daytime sleepiness and improve athletic performance in a group of elite athletes: a non-randomised controlled trial
Secondary ID [1] 281986 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Excessive daytime sleepiness in elite athletes 288415 0
Condition category
Condition code
Other 288766 288766 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention period will be 6 weeks in duration and will consist of:
(1) Ongoing monitoring of progress regarding sleep extension with weekly feedback.
A sleep diary, actigraphy device and mobile phone application will be used to accurately estimate total sleep duration for the entire 6 week period of the intervention.
Feedback will be provided to participants once per week regarding their progress in improving their sleep via SMS messages sent to their personal mobile phones.
(2) Mid-program information feedback and education session.
A mid-program information session will provide a progress report to participants, reinforce sleep health related education and give another opportunity for sleep-related questions to be answered.
This education session will be conducted by a sleep physician (principle investigator) as a group session and will take approximately one hour.
(3) Optional individual telephone consultation.
All intervention group participants will be invited to take part in an individual telephone consultation with the same sleep physician within one to two days of the mid-program education session for any further questions to be answered.
Intervention code [1] 286555 0
Lifestyle
Comparator / control treatment
The control group will receive an initial education session of approximately 1 hour duration from a specialist sleep physcian (principle investigator).
This session will cover the benefits of increased sleep duration and quality, as well as how to achieve these improvements. Both intervention and control group players will be present for this education session. No further intervention will be carried out in the control group.
Control group
Active

Outcomes
Primary outcome [1] 288902 0
Epworth Sleepiness Scale [ESS] score (change from baseline).
Timepoint [1] 288902 0
Baseline and 6 weeks from baseline
Secondary outcome [1] 301287 0
Pittsburgh Sleep Quality lndex [PSQI] score (change from baseline)
Timepoint [1] 301287 0
Baseline and 6 weeks from baseline
Secondary outcome [2] 301288 0
Morningness-Eveningness Questionnaire [MEQ] score (change from baseline)
Timepoint [2] 301288 0
Baseline and 6 weeks from baseline
Secondary outcome [3] 301289 0
Profile of Mood States [POMS] score (change from baseline)
Timepoint [3] 301289 0
Baseline and 6 weeks from baseline
Secondary outcome [4] 301290 0
Perceived Stress Scale [PSS] score (change from baseline)
Timepoint [4] 301290 0
Baseline and 6 weeks from baseline
Secondary outcome [5] 301291 0
Training Stress Score [TSS] score (change from baseline)
Timepoint [5] 301291 0
Baseline and 6 weeks from baseline
Secondary outcome [6] 301292 0
Total sleep time (as measured by actigraphy, sleep diary and sleep app) (change from baseline).
Timepoint [6] 301292 0
Baseline and 6 weeks from baseline
Secondary outcome [7] 301293 0
Psychomotor Vigilance Test [PVT] (change from baseline).
Timepoint [7] 301293 0
Baseline and 6 weeks from baseline
Secondary outcome [8] 301294 0
Reaction time, as assessed by football club (change from baseline).
Timepoint [8] 301294 0
Baseline and 6 weeks from baseline
Secondary outcome [9] 301295 0
Recovery, as assessed by football club (change from baseline).
Timepoint [9] 301295 0
Baseline and 6 weeks from baseline
Secondary outcome [10] 301296 0
Kicking accuracy, as assessed by football club (change from baseline).
Timepoint [10] 301296 0
Baseline and 6 weeks from baseline
Secondary outcome [11] 301297 0
Handball accuracy, as assessed by football club (change from baseline).
Timepoint [11] 301297 0
Baseline and 6 weeks from baseline
Secondary outcome [12] 301298 0
Decision making ability, as assessed by football club (change from baseline).
Timepoint [12] 301298 0
Baseline and 6 weeks from baseline

Eligibility
Key inclusion criteria
This study has different inclusion/exclusion for the two study arms:
Intervention group inclusion criteria –
- Years 1-5 at football club OR
- Year 6+ at football club and had Epworth Sleepiness Scale score > 15 in 2012 study

Control group inclusion criteria -
- Year 6+ at football club
Minimum age
No limit
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Intervention group exclusion criteria:
- Year 6+ at football club with Epworth Sleepiness Scale score less than or equal to 15

Control group exclusion criteria:
- Years 1-5 at football club
- ESS > 15 in 2012 study

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
7/02/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
26
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 286764 0
Commercial sector/Industry
Name [1] 286764 0
Adelaide Football Club
Country [1] 286764 0
Australia
Funding source category [2] 286765 0
University
Name [2] 286765 0
Flinders Partners PTY LTD
Country [2] 286765 0
Australia
Primary sponsor type
Hospital
Name
Adelaide Institute for Sleep Health
Address
Repatriation General Hospital
Daws Rd, Daw Park
South Australia 5041
Country
Australia
Secondary sponsor category [1] 285545 0
University
Name [1] 285545 0
Flinders University
Address [1] 285545 0
Sturt Rd, Bedford Park SA 5042
Country [1] 285545 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288830 0
Southern Adelaide Clinical Human Research Ethics Committee (SAC HREC)
Ethics committee address [1] 288830 0
Ethics committee country [1] 288830 0
Australia
Date submitted for ethics approval [1] 288830 0
Approval date [1] 288830 0
07/02/2013
Ethics approval number [1] 288830 0
068.13

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37978 0
A/Prof Nick Antic
Address 37978 0
Adelaide Institute for Sleep Health
Repatriation General Hospital
202-16 Daws Rd Daw Park SA 5041
Country 37978 0
Australia
Phone 37978 0
+61 08 82752850
Fax 37978 0
Email 37978 0
[email protected]
Contact person for public queries
Name 37979 0
Nick Antic
Address 37979 0
Adelaide Institute for Sleep Health
Repatriation General Hospital
202-16 Daws Rd Daw Park SA 5041
Country 37979 0
Australia
Phone 37979 0
+61 08 82752850
Fax 37979 0
Email 37979 0
[email protected]
Contact person for scientific queries
Name 37980 0
Nick Antic
Address 37980 0
Adelaide Institute for Sleep Health
Repatriation General Hospital
202-16 Daws Rd Daw Park SA 5041
Country 37980 0
Australia
Phone 37980 0
+61 08 82752850
Fax 37980 0
Email 37980 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.