Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000573459
Ethics application status
Approved
Date submitted
19/05/2025
Date registered
3/06/2025
Date last updated
3/06/2025
Date data sharing statement initially provided
3/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of delta-9-tetrahydrocannbinol (THC) on obstructive sleep apnoea and the mechanisms which cause it.
Scientific title
Effect of delta-9-tetrahydrocannabinol on obstructive sleep apnoea severity and its pathophysiological contributors in adults aged 25-70 years.
Secondary ID [1] 314480 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obstructive sleep apnoea 337520 0
Condition category
Condition code
Respiratory 333887 333887 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oral delta-9-tetrahydrocannabinol (THC) 10mg gel capsule/night, approximately 1 hour prior to bedtime. Taken on a single night at least 1-week prior to, or 1-week following, placebo night. Self-administered under scientist supervision.
Intervention code [1] 331104 0
Treatment: Drugs
Comparator / control treatment
Matched placebo gel-capsule containing medium-chain triglyceride. Taken on a single night at least 1-week prior to, or 1-week following, active treatment night. Self-administered under scientist supervision.
Control group
Placebo

Outcomes
Primary outcome [1] 341526 0
Upper airway collapsibility
Timepoint [1] 341526 0
Outcome will be assessed on the night after taking the active medication and on the night after taking placebo
Primary outcome [2] 341622 0
Upper airway muscle responsiveness
Timepoint [2] 341622 0
Outcome will be assessed on the night after taking the active medication and on the night after taking placebo
Primary outcome [3] 341623 0
Respiratory arousal threshold
Timepoint [3] 341623 0
Outcome will be assessed on the night after taking the active medication and on the night after taking placebo
Secondary outcome [1] 447838 0
Respiratory control stability (this is an additional primary outcome)
Timepoint [1] 447838 0
Outcome will be assessed on the night after taking the active medication and on the night after taking placebo
Secondary outcome [2] 447839 0
Obstructive sleep apnoea severity (Apnoea hypopnoea index)
Timepoint [2] 447839 0
Outcome will be assessed on the night after taking the active medication and on the night after taking placebo
Secondary outcome [3] 447840 0
Hypoxic burden
Timepoint [3] 447840 0
Outcome will be assessed on the night after taking the active medication and on the night after taking placebo
Secondary outcome [4] 447841 0
Self-reported sleep quality
Timepoint [4] 447841 0
Outcome will be assessed on the morning after taking the active medication and on the morning after taking placebo
Secondary outcome [5] 447843 0
Adverse events (such as headache, dry mouth, sleepiness, nausea, dizziness)
Timepoint [5] 447843 0
Assessed at each scheduled visit and scheduled and unscheduled communication from enrolment until 3 days post-completion.
Secondary outcome [6] 448091 0
Mean oxygen saturation;
Timepoint [6] 448091 0
Outcome will be assessed on the night after taking the active medication and on the night after taking placebo
Secondary outcome [7] 448092 0
Nadir oxygen saturation
Timepoint [7] 448092 0
Outcome will be assessed on the night after taking the active medication and on the night after taking placebo
Secondary outcome [8] 448093 0
Time spent with oxygen saturation less than 90%
Timepoint [8] 448093 0
Outcome will be assessed on the night after taking the active medication and on the night after taking placebo
Secondary outcome [9] 448094 0
Arousal index
Timepoint [9] 448094 0
Outcome will be assessed on the night after taking the active medication and on the night after taking placebo
Secondary outcome [10] 448095 0
Sleep efficiency
Timepoint [10] 448095 0
Outcome will be assessed on the night after taking the active medication and on the night after taking placebo
Secondary outcome [11] 448096 0
Sleep onset latency
Timepoint [11] 448096 0
Outcome will be assessed on the night after taking the active medication and on the night after taking placebo
Secondary outcome [12] 448097 0
Psychomotor/cognitive function
Timepoint [12] 448097 0
Outcome will be assessed on the evening prior to taking the active/placebo medication, 30 minutes after taking the active/placebo medication and 10 hours after taking the active/placebo medication
Secondary outcome [13] 448098 0
Psychomotor/cognitive function
Timepoint [13] 448098 0
Outcome will be assessed on the evening prior to taking the active/placebo medication, 30 minutes after taking the active/placebo medication and 10 hours after taking the active/placebo medication
Secondary outcome [14] 448099 0
Psychomotor/cognitive function
Timepoint [14] 448099 0
Outcome will be assessed on the evening prior to taking the active/placebo medication, 30 minutes after taking the active/placebo medication and 10 hours after taking the active/placebo medication
Secondary outcome [15] 448100 0
Psychomotor/cognitive function
Timepoint [15] 448100 0
Outcome will be assessed on the evening prior to taking the active/placebo medication, 30 minutes after taking the active/placebo medication and 10 hours after taking the active/placebo medication
Secondary outcome [16] 448101 0
Self-reported drug effects
Timepoint [16] 448101 0
Outcome will be assessed on the evening 30 minutes after taking the active/placebo medication and 10 hours after taking the active/placebo medication

Eligibility
Key inclusion criteria
Presence of obstructive sleep apnoea (apnoea hypopnoea index (AHI)>10events/hr)
Minimum age
25 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current use of OSA therapy
BMI >35 kg/m2,
History of recent (twice monthly over the previous 2 years) cannabis use
Currently taking medications known to affect OSA endotypes or interact with the study medication
Untreated cardiovascular disease
History of significant psychiatric disorder (DASS depression score>/=11, DASS anxiety score>/=8), past suicide attempt, current suicidal ideation (Q9 of PHQ-9>0)
Pregnant/breastfeeding
Unwilling to abstain from driving for 24 hours after taking the study medication.

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
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised randomisation
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
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/06/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 319020 0
Other Collaborative groups
Name [1] 319020 0
Centre for Sleep Science, University of Western Australia
Country [1] 319020 0
Australia
Funding source category [2] 319022 0
Charities/Societies/Foundations
Name [2] 319022 0
Charlies Foundation for Research
Country [2] 319022 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Centre for Sleep Science, University of Western Australia
Address
Country
Australia
Secondary sponsor category [1] 321484 0
None
Name [1] 321484 0
Address [1] 321484 0
Country [1] 321484 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317629 0
The University of Western Australia Human Research Ethics Committee
Ethics committee address [1] 317629 0
Ethics committee country [1] 317629 0
Australia
Date submitted for ethics approval [1] 317629 0
20/09/2024
Approval date [1] 317629 0
02/04/2025
Ethics approval number [1] 317629 0

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

Contacts
Principal investigator
Name 141622 0
Dr Jen Walsh
Address 141622 0
Centre for Sleep Science, The University of Western Australia. 10-12 Parkway, Crawley. WA 6009
Country 141622 0
Australia
Phone 141622 0
+61 8 6488 4604
Fax 141622 0
Email 141622 0
[email protected]
Contact person for public queries
Name 141623 0
Jen Walsh
Address 141623 0
Centre for Sleep Science, The University of Western Australia. 10-12 Parkway, Crawley. WA 6009
Country 141623 0
Australia
Phone 141623 0
+61 8 6488 4604
Fax 141623 0
Email 141623 0
[email protected]
Contact person for scientific queries
Name 141624 0
Jen Walsh
Address 141624 0
Centre for Sleep Science, The University of Western Australia. 10-12 Parkway, Crawley. WA 6009
Country 141624 0
Australia
Phone 141624 0
+61 8 6488 4604
Fax 141624 0
Email 141624 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


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.