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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)
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Scientific title
The effects of AD047 and AD282 on obstructive sleep apnoea (OSA)
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Secondary ID [1]
295454
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Obstructive sleep apnoea
308708
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Condition category
Condition code
Respiratory
307647
307647
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0
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Sleep apnoea
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
301762
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Treatment: Drugs
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Comparator / control treatment
Placebo (sugar pill) - (single dose [one night], oral capsule, immediately prior to sleep, 1-week washout between arms)
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Control group
Active
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Outcomes
Primary outcome [1]
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Sleep apnoea severity using the apnoea/hypopnoea index from the overnight polysomnogram
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Assessment method [1]
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Timepoint [1]
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Single acute overnight sleep studies (placebo vs. drug)
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Secondary outcome [1]
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Sleep efficiency from the overnight polysomnogram
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Assessment method [1]
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Timepoint [1]
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Single acute overnight sleep studies (placebo vs. drug)
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Secondary outcome [2]
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Minute ventilation measured using a nasal mask and pneumotachograph.
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Assessment method [2]
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Timepoint [2]
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Single acute overnight sleep studies (placebo vs. drug)
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Secondary outcome [3]
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Hypoxemia from the overnight polysomnogram measured using oximetry
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Assessment method [3]
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Timepoint [3]
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Single acute overnight sleep studies (placebo vs. drug)
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Secondary outcome [4]
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Driving simulator performance using the AusEd driving simulator
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Assessment method [4]
349084
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Timepoint [4]
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Single acute overnight sleep studies (placebo vs. drug). Driving simulator performance to be measured in the morning after each night study.
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Secondary outcome [5]
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Sleepiness questionnaires (Karolinska and Epworth Sleepiness Scales)
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Assessment method [5]
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Timepoint [5]
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Single acute overnight sleep studies (placebo vs. drug)
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Secondary outcome [6]
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Pharyngeal pressure swings using an epiglottic pressure sensor to calculate arousal threshold and upper airway resistance.
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Assessment method [6]
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Timepoint [6]
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Single acute overnight sleep studies (placebo vs. drug)
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Secondary outcome [7]
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Awake upper airway collapsibility testing using the upper airway collapsibility index (AUCI)
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Assessment method [7]
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Timepoint [7]
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Single acute overnight sleep studies (placebo vs. drug). AUCI to be measured on one occasion prior to sleep
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Secondary outcome [8]
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Arousal index from the overnight polysomnogram
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Assessment method [8]
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Timepoint [8]
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Single acute overnight sleep studies (placebo vs. drug)
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Eligibility
Key inclusion criteria
Otherwise healthy men and women with obstructive sleep apnoea aged 18 years or older.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Crossover
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Other design features
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Phase
Phase 1 / Phase 2
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
23/07/2018
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Actual
13/08/2018
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Date of last participant enrolment
Anticipated
3/06/2019
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Actual
24/01/2019
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Date of last data collection
Anticipated
31/07/2019
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Actual
19/02/2019
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Sample size
Target
10
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Accrual to date
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Final
11
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Recruitment in Australia
Recruitment state(s)
NSW
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Apnimed
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Address [1]
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Apnimed, Inc.
19 Ware St. Apt. 3
Cambridge, MA 02138
USA
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Country [1]
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United States of America
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Primary sponsor type
Commercial sector/Industry
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Name
Apnimed
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Address
Apnimed, Inc.
19 Ware St. Apt. 3
Cambridge, MA 02138
USA
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Country
United States of America
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Secondary sponsor category [1]
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None
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Name [1]
299436
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Address [1]
299436
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Country [1]
299436
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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The University of New South Wales Research Ethics Committee A [EC00397]
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Ethics committee address [1]
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UNSW Research Ethics & Compliance Support
The University of New South Wales
Sydney NSW 2052 Australia
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
300891
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Approval date [1]
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08/06/2018
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Ethics approval number [1]
300891
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HC180255
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Danny Eckert
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Address
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Neuroscience Research Australia (NeuRA)
PO Box 1165
Randwick, NSW, 2031
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Country
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Australia
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Phone
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+61293991814
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Fax
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Query!
Email
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[email protected]
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Contact person for public queries
Name
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Prof Danny Eckert
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Address
85179
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Neuroscience Research Australia (NeuRA)
PO Box 1165
Randwick, NSW, 2031
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Country
85179
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Australia
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Phone
85179
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+61293991814
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Fax
85179
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Query!
Email
85179
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[email protected]
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Contact person for scientific queries
Name
85180
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Prof Danny Eckert
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Address
85180
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Neuroscience Research Australia (NeuRA)
PO Box 1165
Randwick, NSW, 2031
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Country
85180
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Australia
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Phone
85180
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+61293991814
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Fax
85180
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Email
85180
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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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.
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
Current Study Results
No documents have been uploaded by study researchers.
Update to Study Results
Doc. No.
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
4089
Plain language summary
No
The findings of this study show that when the nora...
[
More Details
]
4719
Study results article
Yes
https://pubmed.ncbi.nlm.nih.gov/33734828/ Aishah ...
[
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]
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Different antimuscarinics when combined with atomoxetine have differential effects on obstructive sleep apnea severity.
2021
https://dx.doi.org/10.1152/japplphysiol.01074.2020
N.B. These documents automatically identified may not have been verified by the study sponsor.
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