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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Date data sharing statement initially provided
Date results information initially provided
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of noradrenergic and antimuscarinic agents on obstructive sleep apnoea (OSA) and upper airway muscle activity during sleep
Scientific title
Effects of noradrenergic and antimuscarinic agents on obstructive sleep apnoea (OSA) severity and upper airway muscle activity during sleep in OSA
Secondary ID [1] 292657 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive sleep apnoea 304395 0
Condition category
Condition code
Respiratory 303725 303725 0 0
Sleep apnoea

Study type
Description of intervention(s) / exposure
Reboxetine 4mg + Hyoscine 20mg taken orally just prior to sleep (single dose), 1 week washout. The study intervention for this acute, single night, in-laboratory, sleep study (polysomnography) to be performed at NeuRA will be administered by the researchers to ensure a adherence.
Intervention code [1] 298892 0
Treatment: Drugs
Comparator / control treatment
Placebo (sugar pill), taken orally (participants will act as their own controls in a cross-over design)
Control group

Primary outcome [1] 303094 0
Sleep apnoea severity using the apnoea/hypopnoea index from the overnight polysomnogram
Timepoint [1] 303094 0
Single acute overnight sleep studies (placebo vs. drug)
Secondary outcome [1] 337865 0
Pharyngeal muscle activity during sleep using intramuscular electromyography (EMG).
Timepoint [1] 337865 0
Single acute overnight sleep studies (placebo vs. drug)
Secondary outcome [2] 337866 0
Sleep efficiency from the overnight polysomnogram
Timepoint [2] 337866 0
Single acute overnight sleep studies (placebo vs. drug)
Secondary outcome [3] 337869 0
Minute ventilation measured using a nasal mask and pneumotachograph.
Timepoint [3] 337869 0
Single acute overnight sleep studies (placebo vs. drug)
Secondary outcome [4] 337870 0
Hypoxemia from the overnight polysomnogram measured using oximetry
Timepoint [4] 337870 0
Single acute overnight sleep studies (placebo vs. drug)

Key inclusion criteria
Otherwise healthy men and women with obstructive sleep apnoea aged 18-65 years
Minimum age
18 Years
Maximum age
65 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
-Women lactating, pregnant or of childbearing potential who are not willing to avoid becoming pregnant during the study.
-Patients with any other medical condition which may interfere in the evaluation of the study.
-Patients with a previous history of addiction to alcohol or drugs.
-Patients taking medications known to affect sleep or muscle activity.

Study design
Purpose of the study
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
Other design features
Phase 2
Type of endpoint(s)
Statistical methods / analysis
A paired t-test will be used to compare the apnoea/hypopnoea index (AHI) on drug versus placebo. A sample size of n=12 will allow us to detect a 9 event/h difference in the AHI with >80% power (SD=10).

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 297291 0
Government body
Name [1] 297291 0
NeuroSleep (NHMRC Centre of Research Excellence 1060992)
Address [1] 297291 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [1] 297291 0
Primary sponsor type
Neuroscience Research Australia (NeuRA)
Neuroscience Research Australia (NeuRA)
Barker Street,
Randwick, NSW, 2031
Secondary sponsor category [1] 296261 0
Name [1] 296261 0
Address [1] 296261 0
Country [1] 296261 0

Ethics approval
Ethics application status
Ethics committee name [1] 298401 0
South Eastern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 298401 0
Room G71 East Wing
Edmund Blacket Building
Prince of Wales Hospital
Cnr High and Avoca Streets
Ethics committee country [1] 298401 0
Date submitted for ethics approval [1] 298401 0
Approval date [1] 298401 0
Ethics approval number [1] 298401 0
15/234 (HREC/15/POWH/449)

Brief summary
This study aims to determine if a combined noradrenergic/antimuscarinic intervention changes sleep apnoea severity compared to placebo and the effects on pharyngeal muscle activity and other key sleep parameters.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 76966 0
A/Prof Danny Eckert
Address 76966 0
Neuroscience Research Australia (NeuRA)
PO Box 1165
Randwick, NSW, 2031
Country 76966 0
Phone 76966 0
+61 2 9399 1814
Fax 76966 0
Email 76966 0
Contact person for public queries
Name 76967 0
Ms Carolin Tran
Address 76967 0
Neuroscience Research Australia (NeuRA)
PO Box 1165
Randwick, NSW, 2031
Country 76967 0
Phone 76967 0
+61 2 9399 1886
Fax 76967 0
Email 76967 0
Contact person for scientific queries
Name 76968 0
A/Prof Danny Eckert
Address 76968 0
Neuroscience Research Australia (NeuRA)
PO Box 1165
Randwick, NSW, 2031
Country 76968 0
Phone 76968 0
+61 2 9399 1814
Fax 76968 0
Email 76968 0

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
What data in particular will be shared?
Individual sleep and physiological data will only be made available if participant identity can be assured to remain anonymous in accordance with ethical approval at the commencement of this study.
When will data be available (start and end dates)?
After publication (No end date determined).
Available to whom?
Anyone who has access to the publication.
Available for what types of analyses?
Any purpose.
How or where can data be obtained?
Individual data will be provided within the publication.
What supporting documents are/will be available?
Ethical approval
How or where can supporting documents be obtained?
Type [1] 2103 0
Ethical approval
Citation [1] 2103 0
Link [1] 2103 0
Email [1] 2103 0
Other [1] 2103 0
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary