Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001106729
Ethics application status
Approved
Date submitted
1/10/2013
Date registered
3/10/2013
Date last updated
8/06/2022
Date data sharing statement initially provided
8/06/2022
Date results information initially provided
8/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of zopiclone on obstructive sleep apnoea
Scientific title
The effects of zopiclone on obstructive sleep apnoea severity and symptoms of daytime sleepiness and measures of alertness
Secondary ID [1] 283054 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
ZOPOSA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive sleep apnoea 289894 0
Condition category
Condition code
Respiratory 290258 290258 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Zopiclone (7.5mg) once a day immediately before going to bed, for 30 days. Taken orally.
Adherence will be monitored via drug tablet return
Intervention code [1] 287775 0
Treatment: Drugs
Comparator / control treatment
Placebo, once a day immediately before going to bed, for 30 days. Taken orally.
Control group
Placebo

Outcomes
Primary outcome [1] 290278 0
To determine if zopiclone reduces the apnoea/hypopnoea index (AHI) via overnight polysomnographyin in sleep apnoea patients with low to moderate arousal thresholds
Timepoint [1] 290278 0
1 month
Secondary outcome [1] 304240 0
Symptoms of sleepiness as measured by standardized questionnaires (KSS, ESS, Leeds and FOSQ)
Timepoint [1] 304240 0
In the morning after Night 1 of the study intervention (KSS and Leeds)
In the evening before the study intervention at 1 month (KSS, ESS and FOSQ) and
The following morning after the study intervention at 1 month (KSS and Leeds)
Secondary outcome [2] 304241 0
AusEd driving simulator performance
Timepoint [2] 304241 0
Night 1 in the morning after the study intervention and 1 month in the morning after the study intervention
Secondary outcome [3] 304959 0
Other standard measures of sleep apnoea severity as determined during the polysomnogram (e.g. sleep efficiency, arousal index, event duration, nadir SaO2 and AHI on night 1)
Timepoint [3] 304959 0
Night 1 and 1 month, both after the study intervention

Eligibility
Key inclusion criteria
Men and women with obstructive sleep apnoea (OSA)
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-People without OSA or who are currently on continuous positive airway pressure therapy for OSA
-People with high arousal thresholds (average nadir epiglottic pressure just prior to arousal <-25cmH2O) as determined by overnight polysomnogram (sleep study) during a screening visit.
-Known allergy or previous adverse reaction zopiclone
-Pregnant or nursing mothers

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
Parallel
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/10/2013
Actual
9/10/2013
Date of last participant enrolment
Anticipated
Actual
2/02/2016
Date of last data collection
Anticipated
Actual
15/04/2016
Sample size
Target
30
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 7407 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 287818 0
Government body
Name [1] 287818 0
NHMRC
Country [1] 287818 0
Australia
Primary sponsor type
Other
Name
Woolcock Institute of Medical Research
Address
Woolcock Institute of Medical Research
University of Sydney
431 Glebe point road
Glebe, NSW 2037
Country
Australia
Secondary sponsor category [1] 286547 0
Other
Name [1] 286547 0
Neuroscience Research Australia
Address [1] 286547 0
Barker Street
Randwick
NSW 2031
Country [1] 286547 0
Australia
Secondary sponsor category [2] 286548 0
Hospital
Name [2] 286548 0
Prince of Wales Hospital
Address [2] 286548 0
High Street
Randwick, NSW, 2031
Country [2] 286548 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289766 0
South Eastern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 289766 0
Room G71 East Wing
Edmund Blacket Building
Prince of Wales Hospital
Cnr High and Avoca Streets
RANDWICK, NSW 2031
Ethics committee country [1] 289766 0
Australia
Date submitted for ethics approval [1] 289766 0
Approval date [1] 289766 0
29/01/2013
Ethics approval number [1] 289766 0
12/183 (HREC/12/POWH/394)

Summary
Brief summary
The purpose of this study is to examine the effects of nightly administration of a standard dose of a common sleeping pill (sedative) zopiclone, over one month, on sleep apnoea severity, symptoms of daytime sleepiness, and measures of alertness in sleep apnoea patients
Trial website
Trial related presentations / publications
Carter SG, Carberry JC, Cho G, Fisher LP, Rollo CP, Stevens D, D'Rozario AL, McKenzie DK, Grunstein RR, Eckert DJ. Effects of 1-month of zopiclone on OSA severity & symptoms: A randomised controlled trial. Eur Resp J 2018: In Press: Accepted 23 May.
Public notes

Contacts
Principal investigator
Name 42310 0
Dr Danny Eckert
Address 42310 0
Neuroscience Research Australia Barker Street Randwick, NSW 2031
Country 42310 0
Australia
Phone 42310 0
+61 2 9399 1814
Fax 42310 0
Email 42310 0
d.eckert@neura.edu.au
Contact person for public queries
Name 42311 0
Dr Danny Eckert
Address 42311 0
Neuroscience Research Australia Barker Street Randwick, NSW 2031
Country 42311 0
Australia
Phone 42311 0
+61 2 9399 1814
Fax 42311 0
Email 42311 0
d.eckert@neura.edu.au
Contact person for scientific queries
Name 42312 0
Dr Danny Eckert
Address 42312 0
Neuroscience Research Australia Barker Street Randwick, NSW 2031
Country 42312 0
Australia
Phone 42312 0
+61 2 9399 1814
Fax 42312 0
Email 42312 0
d.eckert@neura.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Carter SG, Carberry JC, Cho G, Fisher LP, Rollo CP... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffect of 1 month of zopiclone on obstructive sleep apnoea severity and symptoms: A randomised controlled trial.2018https://dx.doi.org/10.1183/13993003.00149-2018
EmbasePolysomnography with an epiglottic pressure catheter does not alter obstructive sleep apnea severity or sleep efficiency.2019https://dx.doi.org/10.1111/jsr.12773
Dimensions AI0558 DRONABINOL REDUCES AHI AND DAYTIME SLEEPINESS IN PATIENTS WITH MODERATE TO SEVERE OBSTRUCTIVE SLEEP APNEA SYNDROME2017https://doi.org/10.1093/sleepj/zsx050.557
Dimensions AI0555 A STUDY OF THE IMPACT AND MANAGEMENT OF OBSTRUCTIVE SLEEP APNEA IN THE POSTMENOPAUSAL WOMEN2017https://doi.org/10.1093/sleepj/zsx050.554
N.B. These documents automatically identified may not have been verified by the study sponsor.