Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000469415
Ethics application status
Approved
Date submitted
5/04/2016
Date registered
11/04/2016
Date last updated
17/05/2019
Date data sharing statement initially provided
17/05/2019
Date results information initially provided
17/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of noradrenergic and antimuscarinic agents on upper airway muscle activity during sleep
Scientific title
Effects of noradrenergic and antimuscarinic agents on upper airway muscle activity during sleep in healthy adults
Secondary ID [1] 288699 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Upper airway muscle activity asleep 298153 0
Condition category
Condition code
Respiratory 298317 298317 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
Intervention code [1] 294324 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] 297791 0
Genioglossus muscle activity during sleep using intramuscular electromyography (EMG).
Timepoint [1] 297791 0
Single night acute overnight sleep studies (placebo vs. drug)
Secondary outcome [1] 322268 0
Tensor palatini muscle activity during sleep using intramuscular electromyography (EMG).
Timepoint [1] 322268 0
Single night acute overnight sleep studies (placebo vs. drug)
Secondary outcome [2] 322269 0
Sleep efficiency from the overnight polysomnogram
Timepoint [2] 322269 0
Single night acute overnight sleep studies (placebo vs. drug)
Secondary outcome [3] 322270 0
Upper airway resistance using an epiglottic pressure catheter
Timepoint [3] 322270 0
Single night acute overnight sleep studies (placebo vs. drug)
Secondary outcome [4] 322271 0
Minute ventilation measured using a nasal mask and pneumotachograph.
Timepoint [4] 322271 0
Single night acute overnight sleep studies (placebo vs. drug)
Secondary outcome [5] 322678 0
Arousal index from the overnight polysomnogram
Timepoint [5] 322678 0
Single night acute overnight sleep studies (placebo vs. drug)
Secondary outcome [6] 322679 0
Apnoea/hypopnoea index from the overnight polysomnogram
Timepoint [6] 322679 0
Single night acute overnight sleep studies (placebo vs. drug)

Eligibility
Key inclusion criteria
Healthy men and women aged 18-65 years who do not have any known sleep disorders
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/04/2016
Actual
15/04/2016
Date of last participant enrolment
Anticipated
1/10/2016
Actual
25/07/2016
Date of last data collection
Anticipated
Actual
1/08/2016
Sample size
Target
10
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 293215 0
Government body
Name [1] 293215 0
NeuroSleep (NHMRC Centre of Research Excellence 1060992)
Country [1] 293215 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] 292015 0
None
Name [1] 292015 0
Address [1] 292015 0
Country [1] 292015 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294696 0
South Eastern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 294696 0
Room G71 East Wing
Edmund Blacket Building
Prince of Wales Hospital
Cnr High and Avoca Streets
RANDWICK, NSW 2031
Ethics committee country [1] 294696 0
Australia
Date submitted for ethics approval [1] 294696 0
27/08/2015
Approval date [1] 294696 0
30/11/2015
Ethics approval number [1] 294696 0
15/234 (HREC/15/POWH/449)

Summary
Brief summary
To determine if sleep-related reductions in upper airway muscle activity during sleep will be higher after a combined noradrenergic/antimuscarinic intervention compared to placebo.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 64182 0
A/Prof Danny Eckert
Address 64182 0
Neuroscience Research Australia (NeuRA)
PO Box 1165
Randwick, NSW, 2031
Country 64182 0
Australia
Phone 64182 0
+61 2 9399 1814
Fax 64182 0
Email 64182 0
[email protected]
Contact person for public queries
Name 64183 0
Mr Benjamin Tong
Address 64183 0
Neuroscience Research Australia (NeuRA)
PO Box 1165
Randwick, NSW, 2031
Country 64183 0
Australia
Phone 64183 0
+61 2 9399 1886
Fax 64183 0
Email 64183 0
[email protected]
Contact person for scientific queries
Name 64184 0
A/Prof Danny Eckert
Address 64184 0
Neuroscience Research Australia (NeuRA)
PO Box 1165
Randwick, NSW, 2031
Country 64184 0
Australia
Phone 64184 0
+61 2 9399 1814
Fax 64184 0
Email 64184 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 upper airway muscle data during sleep is provided in the publication.
When will data be available (start and end dates)?
Now (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?
These individual data are provided within the publication.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2105Ethical approval    370281-(Uploaded-15-05-2019-12-24-30)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Lim R, Carberry JC, Wellman A, Grunstein R, Eckert... [More Details]
Plain language summaryNo

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseReboxetine and hyoscine butylbromide improve upper airway function during nonrapid eye movement and suppress rapid eye movement sleep in healthy individuals.2019https://dx.doi.org/10.1093/sleep/zsy261
N.B. These documents automatically identified may not have been verified by the study sponsor.