The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12617000988358
Ethics application status
Approved
Date submitted
1/07/2017
Date registered
10/07/2017
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
The physiological effects of high dose zopiclone in people with obstructive sleep apnoea
Scientific title
The physiological effects of high dose zopiclone in people with obstructive sleep apnoea


Secondary ID [1] 292323 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Zop2x
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnoea 303876 0
Condition category
Condition code
Respiratory 303231 303231 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
High dose zopiclone (15mg), each participant to receive zopiclone once, immediately before bed. Zopiclone to be taken orally in front of the investigator for this acute in-laboratory study.

1 week washout between visits.
Intervention code [1] 298505 0
Treatment: Drugs
Comparator / control treatment
Placebo (sugar pill), taken orally in front of the investigator (participants will act as their own controls in a cross-over design)
Control group
Placebo

Outcomes
Primary outcome [1] 302616 0
Change in sleep apnoea severity as measured by the apnoea hypopnoea index (AHI)
Timepoint [1] 302616 0
Acute overnight studies on zopiclone vs. placebo
Secondary outcome [1] 336524 0
Genioglossus muscle activity during sleep (determined using fine wire electrodes)
Timepoint [1] 336524 0
Acute overnight studies on zopiclone vs. placebo
Secondary outcome [2] 336525 0
Respiratory arousal threshold (negative pharyngeal pressure immediately prior to arousal from sleep, using an epiglottic pressure catheter inserted via the nostril)
Timepoint [2] 336525 0
Acute overnight studies on zopiclone vs. placebo
Secondary outcome [3] 336528 0
Standard polysomnography variables (e.g. nadir SaO2, sleep efficiency, arousal index and sleep duration)
Timepoint [3] 336528 0
Acute overnight studies on zopiclone vs. placebo

Eligibility
Key inclusion criteria
Otherwise healthy, men and women with obstructive sleep apnoea

Patients who have a low respiratory arousal threshold (between zero and -15cmH2O epiglottic pressure just prior to arousal) as estimated from their baseline sleep study.
Minimum age
18 Years
Maximum age
64 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with confirmed overnight blood oxygen saturation nadir (SaO2) less than 70% from baseline sleep study
Patients with a high arousal threshold (less than -25cmH2O epiglottic pressure prior to arousal)

Patients taking medications known to affect sleep or muscle activity

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

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)
Sealed opaque envelopes
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)
Safety/efficacy
Statistical methods / analysis
A sample size of n=30 will allow us to detect a 6 event/h sleep difference in the AHI with ~90% power (SD=9.8) with a two-tailed paired t-test (alpha=0.05)

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
Recruitment hospital [1] 8468 0
Prince of Wales Hospital - Randwick
Recruitment postcode(s) [1] 16552 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 296869 0
Government body
Name [1] 296869 0
National Health and Medical Research Council (NHMRC) CRE and Fellowship fundings
Address [1] 296869 0
National Health and Medical Research Council (NHMRC)
GPO Box 1421
Canberra
ACT, 2601
Country [1] 296869 0
Australia
Primary sponsor type
Other
Name
Neuroscience Research Australia
Address
Margarete Ainsworth Building,
Barker street,
Randwick
NSW 2031
Country
Australia
Secondary sponsor category [1] 295873 0
None
Name [1] 295873 0
Address [1] 295873 0
Country [1] 295873 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298096 0
South Eastern Sydney Local Health District HumanResearch Ethics Committee
Ethics committee address [1] 298096 0
HREC
Room G71 East wing
Edmund Blacket Building
Prince of Wales Hospital
RAndwick
NSW 2031
Ethics committee country [1] 298096 0
Australia
Date submitted for ethics approval [1] 298096 0
Approval date [1] 298096 0
20/06/2017
Ethics approval number [1] 298096 0
16/355 (HREC/16/POWH/710)

Summary
Brief summary
The purpose of this physiology study is to determine the effects of high dose zopiclone (15mg) on obstructive sleep apnoea severity, upper airway muscle activity, the respiratory arousal threshold and breathing parameters during sleep.
Trial website
Nil
Trial related presentations / publications
Nil
Public notes

Contacts
Principal investigator
Name 75974 0
A/Prof Danny Eckert
Address 75974 0
Neuroscience Research Australia
Barker Street
Randwick
NSW 2031
Country 75974 0
Australia
Phone 75974 0
+61 2 9399 1814
Fax 75974 0
Email 75974 0
d.eckert@neura.edu.au
Contact person for public queries
Name 75975 0
A/Prof Danny Eckert
Address 75975 0
Neuroscience Research Australia
Barker Street
Randwick
NSW 2031
Country 75975 0
Australia
Phone 75975 0
+61 2 9399 1814
Fax 75975 0
Email 75975 0
d.eckert@neura.edu.au
Contact person for scientific queries
Name 75976 0
A/Prof Danny Eckert
Address 75976 0
Neuroscience Research Australia
Barker Street
Randwick
NSW 2031
Country 75976 0
Australia
Phone 75976 0
+61 2 9399 1814
Fax 75976 0
Email 75976 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] 2100 0
Ethical approval
Citation [1] 2100 0
Link [1] 2100 0
Email [1] 2100 0
Other [1] 2100 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