Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000364673
Ethics application status
Approved
Date submitted
1/04/2014
Date registered
7/04/2014
Date last updated
10/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of zopiclone on the respiratory arousal threshold in obstructive sleep apnoea
Scientific title
The effect of zopiclone on the respiratory arousal threshold in obstructive sleep apnoea
Secondary ID [1] 284379 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep apnoea 291546 0
Condition category
Condition code
Respiratory 291927 291927 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Zopiclone (7.5mg), once only immediately before going to bed, taken orally.

1 week washout
Intervention code [1] 289108 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] 291831 0
Respiratory arousal threshold (negative pharyngeal pressure immediately prior to arousal from sleep using an epiglottic pressure catheter inserted via the nostril)
Timepoint [1] 291831 0
Acute overnight studies on zopiclone vs. placebo
Secondary outcome [1] 307639 0
Genioglossus muscle activity during sleep measured using fine-wire intramuscular electromyography
Timepoint [1] 307639 0
Acute overnight studies on zopiclone vs. placebo
Secondary outcome [2] 307640 0
Polysomnographic measures of sleep apnoea severity (e.g. AHI, sleep efficiency, arousal index, event duration, and nadir SaO2)
Timepoint [2] 307640 0
Acute overnight studies on zopiclone vs. placebo

Eligibility
Key inclusion criteria
Men and women with obtructive sleep apnoea
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-Known allergy or previous adverse reaction to zopiclone
-Pregnant or nursing mothers
-Patients with any other medical condition which may interfere in the evaluation of the study
- 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
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
It is estimated that studying 12 participants will allow us to detect a 4cmH2O difference (SD=4.5) in the respiratory arousal threshold between placebo and zopiclone conditions (paired t-test) with >80% power. This calculation is based on a similar effect size for other common sedatives and a between night difference in the SD of the respiratory arousal threshold using similar methodology (e.g. Eckert el al, Clin Sci, 2011 and Eckert et al, Sleep 2014).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/04/2014
Actual
15/04/2014
Date of last participant enrolment
Anticipated
Actual
30/09/2014
Date of last data collection
Anticipated
Actual
30/10/2014
Sample size
Target
12
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 289019 0
University
Name [1] 289019 0
University of New South Wales
Country [1] 289019 0
Australia
Funding source category [2] 289020 0
Government body
Name [2] 289020 0
NHMRC (APP1042493)
Country [2] 289020 0
Australia
Primary sponsor type
Other
Name
Neuroscience Research Australia
Address
Barker Street
Randwick
NSW 2031
Country
Australia
Secondary sponsor category [1] 287695 0
None
Name [1] 287695 0
Address [1] 287695 0
Country [1] 287695 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290825 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 290825 0
UNSW Grants Management Office
Rupert Myers Building, Level 3, South Wing
The University of New South Wales
SYDNEY NSW 2052
Ethics committee country [1] 290825 0
Australia
Date submitted for ethics approval [1] 290825 0
Approval date [1] 290825 0
13/03/2012
Ethics approval number [1] 290825 0
HC12028

Summary
Brief summary
The purpose of this physiology study is to determine the effects of zopiclone (sedative) on the awakening (arousal) response to respiratory stimuli during sleep and on upper airway muscle activity and breathing during sleep.
Trial website
Nil
Trial related presentations / publications
Carter SG, Berger MS, Carberry JC, Bilston LE, Butler JE, Tong BKY, Martins RT, Fisher LP, McKenzie DK, Grunstein RR, Eckert DJ. Zopiclone Increases the Arousal Threshold without Impairing Genioglossus Activity in Obstructive Sleep Apnea. Sleep 2016;39:757–766.
Public notes
Nil

Contacts
Principal investigator
Name 47446 0
Dr Danny Eckert
Address 47446 0
Neuroscience Research Australia
Barker Street
Randwick, NSW 2031
Country 47446 0
Australia
Phone 47446 0
+61 2 9399 1814
Fax 47446 0
Email 47446 0
[email protected]
Contact person for public queries
Name 47447 0
Dr Danny Eckert
Address 47447 0
Neuroscience Research Australia
Barker Street
Randwick, NSW 2031
Country 47447 0
Australia
Phone 47447 0
+61 2 9399 1814
Fax 47447 0
Email 47447 0
[email protected]
Contact person for scientific queries
Name 47448 0
Dr Danny Eckert
Address 47448 0
Neuroscience Research Australia
Barker Street
Randwick, NSW 2031
Country 47448 0
Australia
Phone 47448 0
+61 2 9399 1814
Fax 47448 0
Email 47448 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseZopiclone increases the arousal threshold without impairing genioglossus activity in obstructive sleep apnea.2016https://dx.doi.org/10.5665/sleep.5622
N.B. These documents automatically identified may not have been verified by the study sponsor.