Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001269527p
Ethics application status
Not yet submitted
Date submitted
25/09/2024
Date registered
18/10/2024
Date last updated
18/10/2024
Date data sharing statement initially provided
18/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The relationship between sleep architecture and body temperature, and the influence of exercise
Scientific title
The relationship between sleep architecture and body temperature, and the influence of exercise in healthy males adults.
Secondary ID [1] 312962 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep conditions 335136 0
Condition category
Condition code
Physical Medicine / Rehabilitation 331635 331635 0 0
Other physical medicine / rehabilitation
Neurological 331973 331973 0 0
Studies of the normal brain and nervous system
Metabolic and Endocrine 331974 331974 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The participants will be required to complete three interventions in a randomised order. There will be a minimum of 7 day washout between each trial.

1. Control: no exercise-induced changes in core temperature and remain seated in a neutral (22C) environment.
2. Exercise-induced hyperthermia: aerobic exercise on a stationary exercise bike in hot, humid environment (33 degrees Celsius, 60% relative humidity) until core temperature increases by 1.5 degrees Celsius. The exercise duration will dependent upon the core temperature rate of rise, however is anticipated to be 60-80min duration.
3. Passive hyperthermia: Seated in a hot, humid environment (33degrees Celsius, 60% relative humidity) until core temperature increases by 1.5 degrees Celsius. It is likely the passive heating will be 80-120minutes.

All interventions will be in a climate-controlled chamber within an exercise laboratory and will be delivered and supervised by accredited exercise scientists (AES). Heart rate, core and skin temperatures, and perceptual ratings of exertion and thermal stress will be monitored every 5miniutes throughout the interventions.
Intervention code [1] 329497 0
Lifestyle
Comparator / control treatment
1. Control: no exercise-induced changes in core temperature and remain seated in a neutral (22C) environment. Participants will be required to remain seated for 80-120minutes.
Control group
Active

Outcomes
Primary outcome [1] 339366 0
Total Sleep Time
Timepoint [1] 339366 0
Sleep data will be recorded every minute during the evening's sleep after each intervention (3 times total) - approximately 6-8hours duration.
Secondary outcome [1] 439684 0
Core Temperature
Timepoint [1] 439684 0
Data will be collected every 5 min throughout the evening after each intervention (3 interventions total), Each data collection will range from approximately 7-10 hours (depending on the sleep duration of the participant). Data will be collected by an ingestible core temperature capsule prior to the interventions and received via Bluetooth to an associated device.
Secondary outcome [2] 439685 0
Sleep Architecture
Timepoint [2] 439685 0
Sleep data will be recorded in 30s epochs after device is manually turned on at bed time. This process will occur after each intervention (3 interventions total) and data collection will range from approximately 7-10 hours (depending on the sleep duration of the participant).

Eligibility
Key inclusion criteria
In order to volunteer in the project, participants must be:
- Male
- 18 years and over
- Free or injury and illness
- No conditions that may be exacerbated by heat or exercise
- No known sleep conditions
Minimum age
18 Years
Maximum age
60 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria includes
- Females
- Known injury or illness
- Known sleep condition
- Shift worker
- Travelled 3+ time zones within the previous week

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)
Sealed opaque envelopes will be used
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
G*Power analysis was completed and determined for a repeated-measures ANOVA (within factors) with 3 interventions and 8 measurements, an effect size of 0.5, error probability of 0.05 and power of 0.8, a sample size of 6 participants is required.

Following assessment for normality with a Shapiro-Wilk test, A repeated measure ANOVA will be completed to determine effects of condition and time. If differences are identified, a post-hoc analysis will be completed using t-tests. A Bonferroni correction will be applied given the multiple variables being assessed.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/12/2024
Actual
Date of last participant enrolment
Anticipated
3/02/2025
Actual
Date of last data collection
Anticipated
7/03/2025
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 317397 0
University
Name [1] 317397 0
Charles Sturt University
Country [1] 317397 0
Australia
Primary sponsor type
University
Name
Charles Sturt University
Address
Country
Australia
Secondary sponsor category [1] 319685 0
Individual
Name [1] 319685 0
Dr Penelope Larsen - Charles Sturt University
Address [1] 319685 0
Country [1] 319685 0
Australia
Other collaborator category [1] 283192 0
Individual
Name [1] 283192 0
Paige Tonkin - Charles Sturt University
Address [1] 283192 0
Country [1] 283192 0
Australia
Other collaborator category [2] 283193 0
Individual
Name [2] 283193 0
Dr Russell Rayner - Charles Sturt University
Address [2] 283193 0
Country [2] 283193 0
Australia
Other collaborator category [3] 283194 0
Individual
Name [3] 283194 0
Tim Miller - Charles Sturt University
Address [3] 283194 0
Country [3] 283194 0
Australia
Other collaborator category [4] 283195 0
University
Name [4] 283195 0
Karina Liles - Charles Sturt University
Address [4] 283195 0
Country [4] 283195 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 316122 0
Charles Sturt University Human Research Ethics Committee
Ethics committee address [1] 316122 0
Ethics committee country [1] 316122 0
Australia
Date submitted for ethics approval [1] 316122 0
11/11/2024
Approval date [1] 316122 0
Ethics approval number [1] 316122 0

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

Contacts
Principal investigator
Name 136862 0
Dr Melissa Skein
Address 136862 0
Charles Sturt University, Panorama Ave, Bathurst, NSW 2795
Country 136862 0
Australia
Phone 136862 0
+61 02 63384430
Fax 136862 0
Email 136862 0
[email protected]
Contact person for public queries
Name 136863 0
Melissa Skein
Address 136863 0
Charles Sturt University, Panorama Ave, Bathurst, NSW 2795
Country 136863 0
Australia
Phone 136863 0
+61 02 63384430
Fax 136863 0
Email 136863 0
[email protected]
Contact person for scientific queries
Name 136864 0
Melissa Skein
Address 136864 0
Charles Sturt University, Panorama Ave, Bathurst, NSW 2795
Country 136864 0
Australia
Phone 136864 0
+61 02 63384430
Fax 136864 0
Email 136864 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
To respect the privacy of the participants, individual data will not be shared publicly.


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.