Prospective, Randomized, Double-Blind, Placebo-Controlled Trial Assessing the Effect of Eszoplicone on Initial Continuous Positive Airway Pressure (CPAP) Compliance
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- Short term CPAP Compliance
研究概览
简要总结
The purpose of this study is to assess the efficacy of Eszopiclone in improving short and intermediate-term compliance with continuous positive airway pressure (CPAP) in patients newly diagnosed with obstructive sleep apnea (OSA).
详细描述
CPAP is the treatment of choice for patients with OSA. However, patients are frequently intolerant of this therapy initially. After continued use, tolerance is achieved. However, this initial discomfort or intolerance frequently leads to a patient-initiated discontinuation of therapy. It has been shown that CPAP use at 1 month predicts use at 6 months and 1 year. Patients who initially struggle with or are intolerant of CPAP frequently abandon therapy and are unlikely to use it long term. To prevent this, sleep physicians often prescribe short courses of sedatives to help improve initial tolerance and promote better compliance with therapy. However, the effectiveness of this practice has not been validated in a clinical trial. Compliance, in reference to this study is the willingness of the patients to follow the prescribed course of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients
- •Newly diagnosed with OSA who are prescribed CPAP therapy
排除标准
- •Patients < 18 years old
- •Patients over 65 years
- •Pregnant women
- •Patients with chronic liver disease
- •Patients who abuse alcohol
- •Patients taking narcotics or using sedative-hypnotic agents such as Ambien, Klonopin or Benadryl
研究组 & 干预措施
OSA CPAP
干预措施: Eszopiclone (Drug)
Placebo
干预措施: Placebo control (Drug)
结局指标
主要结局
Short term CPAP Compliance
时间窗: 3 months
Intermediate CPAP Compliance
时间窗: 1 year
次要结局
- Quality of Life Issue - Prostate Symptoms for men(1 month, 3 months, 6 months, 9 months, 12 months)
- Quality of Life Issue - Erectile Dysfunction for men(1 month, 3 months, 6 months, 9 months, 12 months)
- Quality of Life Issue - Sleepiness(1 month, 3 months, 6 months, 9 months, 12 months)
- Quality of Life Issue - Fatigue(1 month, 3 months, 6 months, 9 months, 12 months)
- Quality of Life Issue - Subjective Sleep Quality(1 month, 3 months, 6 months, 9 months, 12 months)