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Trial registered on ANZCTR


Registration number
ACTRN12614000881639
Ethics application status
Approved
Date submitted
17/06/2014
Date registered
19/08/2014
Date last updated
19/08/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial to assess the effect of Zopiclone on the uptake of and adherence to Continuous Positive Airway Pressure (CPAP) therapy
Scientific title
A randomised, double-blind, placebo controlled, multi-arm, parallel-group study to assess and compare the efficacy of a 1 week versus 4 week treatment with zopiclone 7.5 mg in the initiation of and compliance with controlled positive airway pressure (CPAP) treatment in patients with mild to moderately severe obstructive sleep apnoea (OSA).
Secondary ID [1] 284815 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive sleep apnea 292197 0
Condition category
Condition code
Respiratory 292535 292535 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A trial to assess and compare the efficacy of 28 days treatment vs 7 days treatment vs placebo of oral zopiclone 7.5mg once daily at bedtime in establishing CPAP therapy in patients with obstructive sleep apnea. Trreatment commences the first night after the sleep study. Treatment compliance is assessed by checking the blister pack for number of capsules used.
Intervention code [1] 289607 0
Treatment: Drugs
Comparator / control treatment
Placebo - Vitamin C tablet
Control group
Placebo

Outcomes
Primary outcome [1] 292397 0
The primary objective of the study is to determine if a short course of a mild sedative (zopiclone 7.5mg) at the onset of treatment improves long-term compliance with CPAP therapy as assessed by hours per night of use and numbers of nights per week at 12 months post treatment initiation. This is assessed by down-loading the data card in the CPAP device.
Timepoint [1] 292397 0
12 months post treatment initiation
Secondary outcome [1] 308863 0
Compliance with CPAP therapy as assessed by hours per night of use and numbers of nights per week at 6 months post treatment initiation. This is assessed by downloading the data card in the CPAP device.
Timepoint [1] 308863 0
6 months post treatment initiation
Secondary outcome [2] 308864 0
To determine if there is any advantage obtained with a 4 week treatment rather than a 1 week treatment in establishing therapy. Hours of use per night, and nights per week of use will be compared between the 2 groups.
Timepoint [2] 308864 0
12 months post treatment initiation
Secondary outcome [3] 308865 0
To try to identify the main reasons behind the decision to discontinue CPAP treatment in those who cease using it. This will be assessed by means of strauctured interviews.
Timepoint [3] 308865 0
12 months post treatment initiation

Eligibility
Key inclusion criteria
1. All patients must have a diagnosis of obstructive sleep apnoea with an AHI greater than or equal to 5 and < 50 (mild to moderately severe sleep apnoea)
2. All patients must be CPAP naive
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Any patient with a diagnosis of severe obstructive sleep apnoea with an AHI greater than or equal to 50
2. Any patient previously treated with CPAP
3. Any patient chronically taking a hypnotic/sleeping pill
4. Any patient with known hypersensitivity to zopiclone
5. Pregnant or breast-feeding women
6. Any patient with a diagnosis of myasthenia gravis
7. Any patient with coeliac disease
8. Any patient with severe hepatic insufficiency
9. Any patient with respiratory failure (obesity hypoventiliation syndrome)
10. Any patient with more than moderate/social alcohol intake
11. Any patient diagnosed with clinical depression

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)
Participants who have been found to have mild to moderately severe OSA will be allocated to one of three treatment arms in a 1:1:1 ratio. Participants will be allocated sequential study numbers, and randomly assigned following simple randomization procedures (computerized random numbers) to 1 of the 3 treatment arms. Allocation is by way of numbered containers. The unblinded pharmacist holds the unblinding codes, all other research staff, and the subject are blinded.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerized random number 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
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/09/2014
Actual
Date of last participant enrolment
Anticipated
31/07/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment outside Australia
Country [1] 6154 0
New Zealand
State/province [1] 6154 0

Funding & Sponsors
Funding source category [1] 289428 0
Charities/Societies/Foundations
Name [1] 289428 0
The Percy and Mary Asser Trust
Country [1] 289428 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Sleep & Breathing (NZ) Ltd
Address
PO Box 109-409
Newmarket
Auckland 1149
Country
New Zealand
Secondary sponsor category [1] 288115 0
None
Name [1] 288115 0
Address [1] 288115 0
Country [1] 288115 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291185 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 291185 0
Ministry of Health
No 1 The Terrace
PO Box 5013
Wellington 6011
Ethics committee country [1] 291185 0
New Zealand
Date submitted for ethics approval [1] 291185 0
25/06/2014
Approval date [1] 291185 0
16/07/2014
Ethics approval number [1] 291185 0

Summary
Brief summary
Obstructive sleep apnoea (OSA) is a common sleep-related disorder which leads to frequent partial or complete airway obstruction during sleep. The resulting sleep fragmentation causes daytime symptoms of sleepiness, fatigue, headache and cognitive dysfunction. In addition OSA is associated with an increased incidence of arterial wall stiffness, hypertension, cardiovascular disease, stroke, diabetes, work-related and motor vehicle accidents. Nasal continuous positive airway pressure (CPAP) devices provide an internal “splint” effect for the upper airway, and are thought to be the best treatment for moderate to severe OSA when used. However, compliance with CPAP therapy remains low with average adherence rates ranging rom 30% to 60%. Multiple international studies have shown that compliance shows an initial drop off in the first week of treatment, and patients who are non-adherent in this early period remain non-compliant hereafter. This is often related to the insomnia that many patients experience when first using CPAP. Our hypothesis is that treating this initial insomnia will result in increased long-term compliance with the therapy, and that this benefit will be seen with just one week of sedative treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 49262 0
Dr Andrew George Veale
Address 49262 0
Sleep & Breathing (NZ) Ltd
Level 3, Building B
Ascot Office Park
93-95 Ascot Avenue
Greenlane
Auckland 1051
Country 49262 0
New Zealand
Phone 49262 0
+64 9 6385255
Fax 49262 0
+64 9 386022
Email 49262 0
[email protected]
Contact person for public queries
Name 49263 0
Carol Veale
Address 49263 0
Sleep & Breathing (NZ) Ltd
PO Box 109-409
Newmarket
Auckland 1149
Country 49263 0
New Zealand
Phone 49263 0
+64 9 6385255
Fax 49263 0
+64 9 6386022
Email 49263 0
[email protected]
Contact person for scientific queries
Name 49264 0
Andrew George Veale
Address 49264 0
Sleep & Breathing (NZ) Ltd
Level 3, Building B
Ascot Office Park
93-95 Ascot Avenue
Greenlane
Auckland 1051
Country 49264 0
New Zealand
Phone 49264 0
+64 9 6385255
Fax 49264 0
+64 9 6386022
Email 49264 0
[email protected]

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