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Trial registered on ANZCTR


Registration number
ACTRN12618001181291
Ethics application status
Approved
Date submitted
10/07/2018
Date registered
17/07/2018
Date last updated
15/05/2019
Date data sharing statement initially provided
14/12/2018
Date results information initially provided
15/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of AD047 and AD282 on obstructive sleep apnoea (OSA)
Scientific title
The effects of AD047 and AD282 on obstructive sleep apnoea (OSA)
Secondary ID [1] 295454 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive sleep apnoea 308708 0
Condition category
Condition code
Respiratory 307647 307647 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: AD047 - (single dose [one night], combination therapy [80mg+5mg], oral capsule, immediately prior to sleep, 1-week washout between arms)
Arm 2: AD282 - (single dose [one night], combination therapy [80mg+2mg], oral capsule, immediately prior to sleep, 1-week washout between arms)

Adherence: medication to be administered by an investigator for these 3 single-night (arms 1 and 2 and placebo) in-lab studies to ensure 100% adherence.
Intervention code [1] 301762 0
Treatment: Drugs
Comparator / control treatment
Placebo (sugar pill) - (single dose [one night], oral capsule, immediately prior to sleep, 1-week washout between arms)
Control group
Active

Outcomes
Primary outcome [1] 306633 0
Sleep apnoea severity using the apnoea/hypopnoea index from the overnight polysomnogram
Timepoint [1] 306633 0
Single acute overnight sleep studies (placebo vs. drug)
Secondary outcome [1] 349081 0
Sleep efficiency from the overnight polysomnogram
Timepoint [1] 349081 0
Single acute overnight sleep studies (placebo vs. drug)
Secondary outcome [2] 349082 0
Minute ventilation measured using a nasal mask and pneumotachograph.
Timepoint [2] 349082 0
Single acute overnight sleep studies (placebo vs. drug)
Secondary outcome [3] 349083 0
Hypoxemia from the overnight polysomnogram measured using oximetry
Timepoint [3] 349083 0
Single acute overnight sleep studies (placebo vs. drug)
Secondary outcome [4] 349084 0
Driving simulator performance using the AusEd driving simulator
Timepoint [4] 349084 0
Single acute overnight sleep studies (placebo vs. drug). Driving simulator performance to be measured in the morning after each night study.
Secondary outcome [5] 349085 0
Sleepiness questionnaires (Karolinska and Epworth Sleepiness Scales)
Timepoint [5] 349085 0
Single acute overnight sleep studies (placebo vs. drug)
Secondary outcome [6] 349086 0
Pharyngeal pressure swings using an epiglottic pressure sensor to calculate arousal threshold and upper airway resistance.
Timepoint [6] 349086 0
Single acute overnight sleep studies (placebo vs. drug)
Secondary outcome [7] 349087 0
Awake upper airway collapsibility testing using the upper airway collapsibility index (AUCI)
Timepoint [7] 349087 0
Single acute overnight sleep studies (placebo vs. drug). AUCI to be measured on one occasion prior to sleep
Secondary outcome [8] 349088 0
Arousal index from the overnight polysomnogram
Timepoint [8] 349088 0
Single acute overnight sleep studies (placebo vs. drug)

Eligibility
Key inclusion criteria
Otherwise healthy men and women with obstructive sleep apnoea aged 18 years or older.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria:
• Any chronic medical condition other than well controlled hypertension, hyperlipidemia, diabetes.
• Any medication known to influence breathing, sleep/arousal or muscle physiology.
• Claustrophobia.
• Inability to sleep supine.
• Known allergy to study medications
• Benign prostatic hyperplasia or urinary retention
• Individuals with underlying cardiac disease, such as arrhythmias.
• Individuals taking psychiatric medications, such as tricyclic antidepressants, or any of the studied medications for medical care.
• History of moderate or severe hepatic or renal impairment.
• History of seizures.
• For women: Pregnancy.

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 1 / Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 300044 0
Commercial sector/Industry
Name [1] 300044 0
Apnimed
Address [1] 300044 0
Apnimed, Inc.
19 Ware St. Apt. 3
Cambridge, MA 02138
USA
Country [1] 300044 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Apnimed
Address
Apnimed, Inc.
19 Ware St. Apt. 3
Cambridge, MA 02138
USA
Country
United States of America
Secondary sponsor category [1] 299436 0
None
Name [1] 299436 0
Address [1] 299436 0
Country [1] 299436 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300891 0
The University of New South Wales Research Ethics Committee A [EC00397]
Ethics committee address [1] 300891 0
UNSW Research Ethics & Compliance Support
The University of New South Wales
Sydney NSW 2052 Australia
Ethics committee country [1] 300891 0
Australia
Date submitted for ethics approval [1] 300891 0
Approval date [1] 300891 0
08/06/2018
Ethics approval number [1] 300891 0
HC180255

Summary
Brief summary
The primary goal of this study is to determine the effects of two drug combinations (known as AD047 and AD282) on sleep apnoea severity (the apnoea/hypopnoea index) compared to a placebo (sugar pill). Other measures of sleep apnoea severity, upper airway function, breathing and symptoms will also be assessed as secondary outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85178 0
Prof Danny Eckert
Address 85178 0
Neuroscience Research Australia (NeuRA)
PO Box 1165
Randwick, NSW, 2031
Country 85178 0
Australia
Phone 85178 0
+61293991814
Fax 85178 0
Email 85178 0
d.eckert@neura.edu.au
Contact person for public queries
Name 85179 0
Prof Danny Eckert
Address 85179 0
Neuroscience Research Australia (NeuRA)
PO Box 1165
Randwick, NSW, 2031
Country 85179 0
Australia
Phone 85179 0
+61293991814
Fax 85179 0
Email 85179 0
d.eckert@neura.edu.au
Contact person for scientific queries
Name 85180 0
Prof Danny Eckert
Address 85180 0
Neuroscience Research Australia (NeuRA)
PO Box 1165
Randwick, NSW, 2031
Country 85180 0
Australia
Phone 85180 0
+61293991814
Fax 85180 0
Email 85180 0
d.eckert@neura.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
This will only be done if participant identity can be assured to remain anonymous in accordance with ethical approval.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary