A randomised controlled trial to assess the effect of Zopiclone on the uptake of and adherence to Continuous Positive Airway Pressure (CPAP) therapy
- Conditions
- Obstructive sleep apneaRespiratory - Sleep apnoea
- Registration Number
- ACTRN12614000881639
- Lead Sponsor
- Sleep & Breathing (NZ) Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 300
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
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
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.[12 months post treatment initiation]
- Secondary Outcome Measures
Name Time Method 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.[6 months post treatment initiation];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.[12 months post treatment initiation];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.[12 months post treatment initiation]