Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001427167
Ethics application status
Approved
Date submitted
24/09/2019
Date registered
15/10/2019
Date last updated
27/10/2021
Date data sharing statement initially provided
15/10/2019
Date results provided
27/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of a novel drug combination on sleep quality in people with sleep apnoea.
Scientific title
The effects of combination therapy (AD173) on sleep efficiency and the respiratory arousal threshold in people with sleep apnoea
Secondary ID [1] 299066 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive sleep apnoea 314092 0
Condition category
Condition code
Respiratory 312471 312471 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Randomised, placebo-controlled, cross-over study (~1 week wash-out between visits):
Arm 1: single dose of AD036 drug combination (2 oral capsules) immediately prior to sleep (single overnight study)
Arm 2: single dose of AD173 drug combination (2 oral capsules) immediately prior to sleep (single overnight study)
Interventions will be administered by a study investigator on each visit just prior to sleep for these acute sleep studies to ensure adherence.
Intervention code [1] 315333 0
Treatment: Drugs
Comparator / control treatment
AD173 vs. AD036 (control arm)
Control group
Active

Outcomes
Primary outcome [1] 321111 0
Difference in sleep efficiency (% total sleep time) between AD036 vs. AD173 measured via polysomnography during each overnight sleep study
Timepoint [1] 321111 0
Each overnight sleep study (2 single night sleep studies, one on each arm, approximately 1 week wash out between studies)
Secondary outcome [1] 374028 0
Difference in respiratory arousal threshold (negative epiglottic pressure in cmH2O just prior to arousal) between AD036 vs. AD173 measured via polysomnography during each overnight sleep study
Timepoint [1] 374028 0
Each overnight sleep study (2 single night sleep studies, one on each arm, approximately 1 week wash out between studies)
Secondary outcome [2] 374029 0
Difference in apnoea/hypopnoea index (number of events/h sleep) between AD036 vs. AD173 measured via polysomnography during each overnight sleep study
Timepoint [2] 374029 0
Each overnight sleep study (2 single night sleep studies, one on each arm, approximately 1 week wash out between studies)
Secondary outcome [3] 374030 0
Difference in Karolinska Sleepiness Scale (KSS) questionnaire between AD036 vs. AD173 measured after awakening after each sleep study
Timepoint [3] 374030 0
After each overnight sleep study (2 single night sleep studies, one on each arm, approximately 1 week wash out between studies)
Secondary outcome [4] 374031 0
Difference in AusEd driving simulator task performance (objective alertness) between AD036 vs. AD173 measured after awakening after each sleep study
Timepoint [4] 374031 0
After each overnight sleep study (2 single night sleep studies, one on each arm, approximately 1 week wash out between studies)
Secondary outcome [5] 375099 0
Difference in arousal index (number of events/h sleep) between AD036 vs. AD173 measured via polysomnography during each overnight sleep study
Timepoint [5] 375099 0
Each overnight sleep study (2 single night sleep studies, one on each arm, approximately 1 week wash out between studies)
Secondary outcome [6] 375100 0
Difference in nadir oxygen saturation (%) between AD036 vs. AD173 measured via polysomnography during each overnight sleep study
Timepoint [6] 375100 0
Each overnight sleep study (2 single night sleep studies, one on each arm, approximately 1 week wash out between studies)

Eligibility
Key inclusion criteria
Otherwise healthy men and women with obstructive sleep apnoea
-Adults between 18 to 64 years of age, inclusive
- BMI between 18.5 and 40.0 kg/m2, inclusive
Minimum age
18 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. History of narcolepsy.
2. Clinically significant craniofacial malformation.
3. Clinically significant cardiac disease (e.g., rhythm disturbances, coronary artery disease or cardiac failure) or hypertension requiring more than 2 medications for control.
4. Clinically significant neurological disorder, including epilepsy/convulsions.
5. History of schizophrenia, schizoaffective disorder or bipolar disorder according to Diagnostic and Statistical Manual of Mental Disorders-V (DSM V) or International Classification of Disease tenth edition criteria.
6. History of attempted suicide or suicidal ideation within 1 year prior to screening, or current suicidal ideation.
7. History of clinically significant constipation, gastric retention, or urinary retention, benign prostatic hyperplasia.
8. History of moderate or severe hepatic or renal impairment.
9. History of drug abuse or substance use disorder as defined in DSM-V within 12 months.
10. A significant acute illness or infection requiring medical treatment in the past 30 days.
11. Clinically significant cognitive dysfunction.
12. Untreated narrow angle glaucoma.
13. Women who are pregnant or nursing.
14. Known allergy to any of the study medications.
15. Any medication known to influence breathing, sleep/arousal or muscle physiology.
16. Clausrophobia.
17. Use of medications from the list of disallowed concomitant medications.
18. Treatment with strong cytochrome P450 3A4 (CYP3A4) inhibitors, strong cytochrome P450 2D6 (CYP2D6) inhibitors, or monoamine oxidase inhibitors (MAOI) within 14 days of the start of study.
19. Use of another investigational agent within 30 days or 5 half-lives, whichever is longer, prior to dosing.

Other Exclusions
20. <5 hours typical sleep duration.
21. Night- or shift-work sleep schedule.
22. Employment as a commercial driver or operator of heavy or hazardous equipment.
23. Smoking more than 10 cigarettes or 2 cigars per day.
24. Unwilling to use contraception during the study (if relevant).
25. Unwilling to avoid alcohol on the days of the study.
26. Unwilling to limit caffeinated beverage intake (e.g., coffee, cola, tea) to 400 mg/day or less of caffeine, not to be used within 3 hours of bedtime on study days.
27. Any condition that in the investigator’s opinion would present an unreasonable risk to the participant, or which would interfere with their participation in the study or confound study interpretation.
28. Participant considered by the investigator, for any reason, an unsuitable candidate to receive the study medications or unable or unlikely to understand or comply with the study design.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Completed
Date of first participant enrolment
Anticipated
21/10/2019
Actual
6/11/2019
Date of last participant enrolment
Anticipated
Actual
11/06/2020
Date of last data collection
Anticipated
Actual
18/06/2020
Sample size
Target
12
Accrual to date
Final
13
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 303601 0
Commercial sector/Industry
Name [1] 303601 0
Apnimed Australia Pty Ltd.
Country [1] 303601 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Sturt Rd, Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 304033 0
None
Name [1] 304033 0
Address [1] 304033 0
Country [1] 304033 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304130 0
Southern Adelaide Clinical Research Ethics Committee
Ethics committee address [1] 304130 0
Ethics committee country [1] 304130 0
Australia
Date submitted for ethics approval [1] 304130 0
Approval date [1] 304130 0
13/09/2019
Ethics approval number [1] 304130 0
89.19

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

Contacts
Principal investigator
Name 95914 0
Prof Danny Eckert
Address 95914 0
Adelaide Institute for Sleep Health, Flinders University,
Level 2, Mark Oliphant Building
5 Laffer Drive, Bedford Park SA 5042
Country 95914 0
Australia
Phone 95914 0
+61 8 74219780
Fax 95914 0
Email 95914 0
[email protected]
Contact person for public queries
Name 95915 0
Carolin Tran
Address 95915 0
Adelaide Institute for Sleep Health, Flinders University,
Level 2, Mark Oliphant Building
5 Laffer Drive, Bedford Park SA 5042
Country 95915 0
Australia
Phone 95915 0
+61 8 7421 9873
Fax 95915 0
Email 95915 0
[email protected]
Contact person for scientific queries
Name 95916 0
Jayne Carberry
Address 95916 0
Adelaide Institute for Sleep Health, Flinders University,
Level 2, Mark Oliphant Building
5 Laffer Drive, Bedford Park SA 5042
Country 95916 0
Australia
Phone 95916 0
+61 8 82015196
Fax 95916 0
Email 95916 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?
De-identified individual participant data for the key study outcomes will be provided in the publication.
When will data be available (start and end dates)?
After the study is complete and the findings are published. No end date.
Available to whom?
Everyone with access to the journal publication.
Available for what types of analyses?
Any purpose.
How or where can data be obtained?
Via the journal publication.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5021Ethical approval    378214-(Uploaded-15-11-2019-16-34-04)-Study-related document.pdf



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.