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Trial registered on ANZCTR


Registration number
ACTRN12617001326381
Ethics application status
Approved
Date submitted
12/09/2017
Date registered
15/09/2017
Date last updated
15/05/2019
Date data sharing statement initially provided
15/05/2019
Date results information initially provided
15/05/2019
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
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
ACTRN12616000469415

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

Intervention/exposure
Study type
Interventional
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
Placebo

Outcomes
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)

Eligibility
Key inclusion criteria
Otherwise healthy men and women with obstructive sleep apnoea aged 18-65 years
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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
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
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
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] 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
Australia
Primary sponsor type
Other
Name
Neuroscience Research Australia (NeuRA)
Address
Neuroscience Research Australia (NeuRA)
Barker Street,
Randwick, NSW, 2031
Country
Australia
Secondary sponsor category [1] 296261 0
None
Name [1] 296261 0
Address [1] 296261 0
Country [1] 296261 0

Ethics approval
Ethics application status
Approved
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
RANDWICK, NSW 2031
Ethics committee country [1] 298401 0
Australia
Date submitted for ethics approval [1] 298401 0
27/08/2015
Approval date [1] 298401 0
30/11/2015
Ethics approval number [1] 298401 0
15/234 (HREC/15/POWH/449)

Summary
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

Contacts
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
Australia
Phone 76966 0
+61 2 9399 1814
Fax 76966 0
Email 76966 0
d.eckert@neura.edu.au
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
Australia
Phone 76967 0
+61 2 9399 1886
Fax 76967 0
Email 76967 0
c.tran@neura.edu.au
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
Australia
Phone 76968 0
+61 2 9399 1814
Fax 76968 0
Email 76968 0
d.eckert@neura.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary