A randomised controlled trial to assess the effect of Zopiclone on the uptake of and adherence to Continuous Positive Airway Pressure (CPAP) therapy

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).

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000881639

Enrollment

300

Registered

2014-08-19

Start date

2014-09-29

Completion date

2015-07-31

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

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

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

Outcome results