ACTRN12614000881639尚未招募4 期
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).
Sleep & Breathing (NZ) Ltd0 个研究点目标入组 300 人开始时间: 2014年8月19日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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