Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000876796
Ethics application status
Approved
Date submitted
23/05/2022
Date registered
21/06/2022
Date last updated
12/06/2024
Date data sharing statement initially provided
21/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Get active for sleep apnoea: what is the impact of high-intensity interval training?
Scientific title
Assessing the impact of high-intensity interval training on the pathophysiology causing obstructive sleep apnoea
Secondary ID [1] 307086 0
None
Universal Trial Number (UTN)
Trial acronym
GASP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnoea 326279 0
Obesity 326280 0
Condition category
Condition code
Respiratory 323588 323588 0 0
Sleep apnoea
Diet and Nutrition 323589 323589 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The GASP study will investigate a high intensity interval training intervention on the pathophysiology of obstructive sleep apnoea (OSA).

Participants will complete a 12- week program consisting of:

1) 2 non-consecutive supervised exercise sessions per week and;
2) a total of 90 minutes of walking at a comfortable pace per week in their own time.

The 2 non-consecutive supervised exercise sessions will be in person at a training facility and will be conducted and supervised by a study team member in groups of 1 - 8 participants. Each session will begin with the participant doing a 5-minute warm up on a cycle ergometer. The participant will then do 4 repetitions on the cycle ergometer of 3-minutes at >80% HRmax and then resting for 3 minutes. The total time of the exercise session will be ~30 minutes. To ensure the target HR zone is achieved and maintained study staff will monitor adherence using heart rate telemetry. The speed of the cycle ergometer will be adjusted to ensure the target heart rate is achieved and maintained. The target heart rate zones will be calculated for each participant based on the results of their pre-intervention fitness tests.

In addition to attending group training sessions, participants will walk for 90 minutes each week at home in their own time. The 90 minutes may be divided up into durations of their own choosing (i.e., 3 x 30 min sessions per week, 2 x 45 min sessions per week) so long as it totals 90 minutes each week. Each walking session will be done at a comfortable pace (the participant can still hold a conversation).

Participants will be given a Fitbit Charge 5 device to measure sleep and activity. They will wear the Fitbit device for 1 week prior to beginning the intervention, for the 12- weeks of the intervention and for 1 week after the intervention ends for a total of 14 weeks. The Fitbit device will also be used to monitor adherence to the at home walking sessions.

Participants will receive a progress/ motivational text message 1 time per week for the 12- week intervention.

Patient's sleep (i.e. OSA severity) and physiological traits will be assessed via two overnight sleep studies before and after the intervention in order to assess how exercise impacts OSA and its underlying physiology. Patients cardiorespiratory fitness will also be assessed pre and post intervention.
Intervention code [1] 323572 0
Lifestyle
Intervention code [2] 323659 0
Treatment: Other
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331358 0
Upper airway muscle response/compensation derived from overnight polysomnography.
Timepoint [1] 331358 0
This outcome will be assessed in each participant within 14 days pre- Intervention and within 14 days post- intervention completion.
Primary outcome [2] 331359 0
OSA severity as assessed using the Apnoea/Hypopnea index from overnight polysomnography.
Timepoint [2] 331359 0
This outcome will be assessed in each participant within 14 days pre- Intervention and within 14 days post- intervention completion.
Secondary outcome [1] 409601 0
Whole body composition as measured using a bioelectric impedance analyser.
Timepoint [1] 409601 0
This outcome will be assessed in each participant within 14 days pre- Intervention and within 14 days post- intervention completion.
Secondary outcome [2] 409602 0
Cardiorespiratory fitness as measured using the submaximal Astrand test.
Timepoint [2] 409602 0
This outcome will be assessed in each participant within 14 days pre- Intervention and within 14 days post- intervention completion.
Secondary outcome [3] 410701 0
Upper airway collapsibility as derived from overnight polysomnography.
Timepoint [3] 410701 0
This outcome will be assessed in each participant within 14 days pre- Intervention and within 14 days post- intervention completion.
Secondary outcome [4] 410702 0
Respiratory arousal threshold as derived from overnight polysomnography.
Timepoint [4] 410702 0
This outcome will be assessed in each participant within 14 days pre- Intervention and within 14 days post- intervention completion.
Secondary outcome [5] 410703 0
Loop gain as derived from overnight polysomnography.
Timepoint [5] 410703 0
This outcome will be assessed in each participant within 14 days pre- Intervention and within 14 days post- intervention completion.


Eligibility
Key inclusion criteria
-Moderate/severe OSA (10 =>AHI <= 50 events/hr)
-Overweight (25 >= BMI <= 35 kg/m2)
-Engaged in less than or equal to 5 sessions of high intensity training within in the past 6 months
-Physical activity levels have remained below the following in the past three months
-<150 minutes of moderate-intensity activity or walking in a typical week; and
-<75 minutes of vigorous-intensity activity in a typical week
-At stable medication doses (for greater than 3 months)
-Diagnosed with OSA and not currently using OSA treatment or are willing to abstain from using OSA treatment for the duration of the study.
-Epworth Sleepiness Scale (ESS) greater than 16 at screening
-Not actively trying to lose weight
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-Known or suspected significant cardiovascular, pulmonary, or metabolic disease
-Uncontrolled hypertension (>159/99 mm Hg)
-Patients with safety concerns (drowsy driving within the past 2 years)
-Receiving medication that could affect ventilation (i.e., morphine derivatives, benzodiazepines, theophylline) or muscle control.
-Previous surgical treatment for OSA and/or obesity
-Women who are pregnant or currently trying to become pregnant
-Inability to exercise due to orthopaedic or musculoskeletal problems
-Score below 2 on the STOP Bang Questionnaire
-Allergy to any of the local anaesthetics used to insert the genioglossus intramuscular electrodes (e.g. Lidocaine, Lidocaine–Prilocaine). The local anaesthetic is used to reduce the the potential pain or discomfort caused by the insertion of the intramuscular electrodes during the polysomnography which is part of the assessment of study outcomes.

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
Recruiting
Date of first participant enrolment
Anticipated
30/06/2022
Actual
27/07/2022
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
30/06/2026
Actual
Sample size
Target
24
Accrual to date
3
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 311520 0
Other
Name [1] 311520 0
Monash Lung Sleep Allergy & Immunology Institute
Country [1] 311520 0
Australia
Funding source category [2] 311525 0
University
Name [2] 311525 0
Monash University
Country [2] 311525 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Department of Physiology and School of Psychological Sciences Faculty of Medicine, Nursing and Health Sciences Monash University
264 Ferntree Gully Road
Notting Hill, VIC 3168, Australia
Country
Australia
Secondary sponsor category [1] 312910 0
None
Name [1] 312910 0
Address [1] 312910 0
Country [1] 312910 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310876 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 310876 0
Ethics committee country [1] 310876 0
Australia
Date submitted for ethics approval [1] 310876 0
25/01/2022
Approval date [1] 310876 0
24/02/2022
Ethics approval number [1] 310876 0
31718

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

Contacts
Principal investigator
Name 119190 0
A/Prof Bradley Edwards
Address 119190 0
Sleep and Circadian Medicine Laboratory Department of Physiology, School of Psychological Sciences and Turner Institute for Brain and Mental Health
Faculty of Medicine, Nursing and Health Sciences Monash University
264 Ferntree Gully Road
Notting Hill, VIC 3168, Australia
Country 119190 0
Australia
Phone 119190 0
+61 402 476 225
Fax 119190 0
Email 119190 0
[email protected]
Contact person for public queries
Name 119191 0
Caroline Beatty
Address 119191 0
Sleep and Circadian Medicine Laboratory Department of Physiology, School of Psychological Sciences and Turner Institute for Brain and Mental Health
Faculty of Medicine, Nursing and Health Sciences Monash University
264 Ferntree Gully Road
Notting Hill, VIC 3168, Australia
Country 119191 0
Australia
Phone 119191 0
+61399054043
Fax 119191 0
Email 119191 0
[email protected]
Contact person for scientific queries
Name 119192 0
Caroline Beatty
Address 119192 0
Sleep and Circadian Medicine Laboratory Department of Physiology, School of Psychological Sciences and Turner Institute for Brain and Mental Health
Faculty of Medicine, Nursing and Health Sciences Monash University
264 Ferntree Gully Road
Notting Hill, VIC 3168, Australia
Country 119192 0
Australia
Phone 119192 0
+61399054043
Fax 119192 0
Email 119192 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The measures of the OSA physiology, cardiorespiratory fitness, anthropometric measures and OSA severity pre and post intervention.
When will data be available (start and end dates)?
Start: Following completion of the study (approximately June 2023)
End: No end date.
Available to whom?
Data from this research project may be uploaded to a public repository and/or used in future research projects. If the data is uploaded to a public repository and/or used in future research projects, it will be provided in such a way that the participant cannot be identified. The results of this research project will also be published and presented in a variety of forums. In any publication and/or presentation, information will be provided in such a way that the participant cannot be identified.
Available for what types of analyses?
Any purpose.
How or where can data be obtained?
Data from this research project may be uploaded to a public repository or obtained by emailing the principal investigator ([email protected]).


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.