Effect of Eszopiclone on Adherence to Continuous Positive Airway Pressure (CPAP) and Severity of Insomnia in Patients With Comorbidity Between Insomnia and Obstructive Sleep Apnea (COMISA)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Short-term CPAP adherence (use > 4 hours per night through Resmed program)
研究概览
简要总结
The comorbidity between obstructive sleep apnea (OSA) and insomnia (COMISA) is common, and associated with poorer sleep quality. CPAP adherence among COMISA patients is worst than among those with OSA only. The investigators will compare the effect of Eszopiclone 3mg or placebo for 14 days on adherence to CPAP after 30 days and after 6 months.
详细描述
The comorbidity between OSA and insomnia (COMISA) is common. COMISA leads to additive impairment of quality of sleep and quality of life compared to patients with insomnia or OSA alone. Patients with COMISA demonstrate worse adherence to CPAP compared to patients with isolated OSA. The best therapeutic approach for patients with COMISA is still unclear. Hypnotics have not been tested among patients with COMISA and indication for CPAP.
The investigators will compare the effect of Eszopiclone 3mg or placebo for 14 days on adherence to CPAP after 30 days and after 6 months. In addition, the investigators will assess the effect eszopiclone on insomnia severity, quality of life, anxiety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
盲法说明
double-blind
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinical diagnosis of Insomnia;
- •Moderate or severe OSA (AHI ≥ 15 events/h), diagnosed by polysomnography.
排除标准
- •Craniofacial anatomical abnormalities or severe otorhinolaryngological disorders that potentially impair CPAP use;
- •Use of hypnotics for more than 7 days in the last 2 months;
- •Renal dysfunction (serum creatinine >2mg/dL);
- •Severe liver or cardiac dysfunction;
- •Alcoholism;
- •Previous CPAP or mandibular advancement device for OSA treatment in the last 12 months.
研究组 & 干预措施
Placebo
Placebo at bed time for 14 days
干预措施: Placebo (Drug)
Eszopiclone
Eszopiclone 3mg at bed time for 14 days
干预措施: Eszopiclone 3 mg (Drug)
结局指标
主要结局
Short-term CPAP adherence (use > 4 hours per night through Resmed program)
时间窗: 4 weeks
Compare the effect of Eszopiclone 3mg or placebo for 14 days on one-month CPAP adherence (use \> 4 hours per night through Resmed program) after 4 weeks days. Adherence to CPAP will be assess by the average number of hours of use (\>=4h). The investigators will use Resmed's program for this analysis.
次要结局
- Long-term CPAP adherence (use > 4 hours per night through Resmed program) Compare sleep quality, insomnia and anxiety(6 months)
研究者
Pedro Rodrigues Genta
Principal Investigador
University of Sao Paulo General Hospital