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Trial registered on ANZCTR


Registration number
ACTRN12620001272987
Ethics application status
Approved
Date submitted
21/10/2020
Date registered
25/11/2020
Date last updated
5/08/2022
Date data sharing statement initially provided
25/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Does sleep medication affect next day performance in athletes
Scientific title
The impact of sleep medication on the physiological response to exercise in well-trained
athletes.
Secondary ID [1] 302574 0
Nil known
Universal Trial Number (UTN)
U1111-1259-8937
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep 319454 0
Condition category
Condition code
Neurological 317424 317424 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The proposed study will employ a repeated measures design in which participants will complete a control condition and two experimental conditions in a randomised and
counterbalanced order. Participants will attend the laboratory on four occasions (1
exercise familiarisation session and three experimental sessions), each separated by 7 days. On each occasion, participants will complete one of three conditions:
• Placebo tablet
• Temazepam (10 mg) oral form, provided once, 30 minutes before bed
• Zolpidem Tartrate (10 mg) oral form, provided once, 30 minutes before bed

These are standard, recommended doses for these medications.

A whole mouth check will be conducted following consumption of the placebo, Temazepam and Zolpidem Tartrate in each participant
Intervention code [1] 318864 0
Treatment: Drugs
Comparator / control treatment
A placebo tablet will be provided to participants 30 minutes before bedtime.

The placebo will consist of a microcellulose capsule.
Control group
Placebo

Outcomes
Primary outcome [1] 325460 0
Overnight sleep:
Sleep will be recorded using polysomnography equipment (Grael; Compumedics, Melbourne, VIC, Australia) with a standard montage of electrodes. Electrodes will be applied in the 60 min prior to lights out and include three electroencephalograms (C4-M1, F4-M1, O2-M1), two electrooculograms (left/right outer canthus), and a submental electromyogram. All sleep records will be blinded and manually scored in 30-s epochs by the same technician according to established criteria.
Timepoint [1] 325460 0
Measured overnight, throughout the night measured immediately after consuming the intervention or placebo
Secondary outcome [1] 388045 0
Next day cognitive performance:
Sustained attention will be assessed using the psychomotor vigilance task (PVT-192; Ambulatory Monitoring Inc., New York, NY, USA). The PVT is a hand-held device with an upper surface that contains a four-digit LED display and two push-button response keys. Participants will attend to the LED display for the duration of the test (10 min) and press the appropriate response key with the thumb of their dominant hand as quickly as possible after the appearance of a visual stimulus (presented at a variable interval of 2–10 s).
Timepoint [1] 388045 0
30 minutes after waking
Secondary outcome [2] 388047 0
Self perceived sleep quantity and quality:
Sleep quality will be assessed using a 7-point scale, where 1 = “extremely poor”, 2 = “very poor”, 3 = “poor”, 4 = “average”, 5 = “good”, 6 = “very good”, and 7 = “extremely good”. Participants will be verbally asked “how much sleep do you think you got?” and “how long did it take you to fall asleep?”.
Timepoint [2] 388047 0
30 minutes after waking
Secondary outcome [3] 388048 0
Next day exercise performance:
Participants will complete a 10min time trial on a cycle ergometer (WattBike, UK). Instructions will be to performance as much work (measured in Watts) as possible in 10 minutes.
Timepoint [3] 388048 0
40 minutes after waking

Eligibility
Key inclusion criteria
Participants must be non-smoking males between the ages of 18-35 years, be free of any medical conditions that are likely to impact sleep, not be taking medication that is likely to disrupt sleep, and must meet the criteria of a well-trained athlete (i.e., train 3-7 times per week for at least 60 min for the last 3-5 years).
Minimum age
18 Years
Maximum age
35 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded if they have unusual sleep/wake patterns, work irregular
hours, experienced a previous adverse reaction to any sleep medication, suffer from lung disease, liver damage, glaucoma, epilepsy, depression, psychosis, schizophrenia, low blood pressure, any blood disorder, or myasthenia gravis, or if they have a history of drug or alcohol dependence. Participants who currently use sleep medication will be excluded from the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be sealed from all members of the research team, with the exception of one person. This information will be concealed in a sealed opaque envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This is a repeated measures trial in which participants will complete all three conditions. Participants will be randomly assigned to an order in which they will complete the conditions. The order will be pulled out of a hat for each participant.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Assuming an effect size (d) of 0.60 and alpha of .05, 18 participants will be required to have 80% power to detect differences between the control condition and one of the sleep
medication conditions [Paul MA, Gray G, Kenny G, Pigeau RA (2003). Impact of
melatonin, zaleplon, zopiclone and temazepam on psychomotor performance. Aviat. Space Environ. Med, 74, 12631270].

All data will be analysed with a general linear mixed model using the R package lme4 (R Core Team). A random intercept for ‘subjects’ will be included to account for intraindividual dependencies and interindividual heterogeneity. All models will be estimated using restricted maximum likelihood. Data points with a value that are greater than 2 standard deviations from the mean will be removed.. p-values will be obtained using Type II Wald F tests with Kenward-Roger degrees of freedom as implemented in the R package. Results will be reported as mean estimates and 95% confidence intervals.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
18
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 307006 0
University
Name [1] 307006 0
Australian Catholic University
Country [1] 307006 0
Australia
Primary sponsor type
University
Name
Australian Catholic University
Address
Australian Catholic University
McAuley at Banyo
1100 Nudgee Road
Banyo, QLD, 4014
Country
Australia
Secondary sponsor category [1] 307584 0
University
Name [1] 307584 0
Central Queensland University
Address [1] 307584 0
44 Greenhill Road, Wayville SA 5034
Country [1] 307584 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307138 0
Central Queensland University Human Ethics Commitee
Ethics committee address [1] 307138 0
Ethics committee country [1] 307138 0
Australia
Date submitted for ethics approval [1] 307138 0
19/05/2021
Approval date [1] 307138 0
16/07/2021
Ethics approval number [1] 307138 0
Ethics committee name [2] 307376 0
Australian Catholic University Human Research Ethics Commitee
Ethics committee address [2] 307376 0
Ethics committee country [2] 307376 0
Australia
Date submitted for ethics approval [2] 307376 0
02/08/2022
Approval date [2] 307376 0
Ethics approval number [2] 307376 0

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

Contacts
Principal investigator
Name 106166 0
A/Prof Charli Sargent
Address 106166 0
CQUniversity Adelaide
44 Greenhill Road, Wayville SA 5034
Country 106166 0
Australia
Phone 106166 0
+61 8 8378 4523
Fax 106166 0
Email 106166 0
charli.sargent@cqu.edu.au
Contact person for public queries
Name 106167 0
Shona Halson
Address 106167 0
Australian Catholic University
1100 Nudgee Road, Banyo
QLD 4014
Country 106167 0
Australia
Phone 106167 0
+61422224491
Fax 106167 0
Email 106167 0
shona.halson@acu.edu.au
Contact person for scientific queries
Name 106168 0
Shona Halson
Address 106168 0
Australian Catholic University
1100 Nudgee Road, Banyo
QLD 4014
Country 106168 0
Australia
Phone 106168 0
+61422224491
Fax 106168 0
Email 106168 0
shona.halson@acu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.