Intensive Versus Standard Follow up to Improve Continuous Positive Airway Pressure Compliance: The Greek Experience
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,836
- 主要终点
- Effect of intensive intervention on CPAP adherence
研究概览
简要总结
The purpose of this study was to compare the effects on sleepiness, quality of life, depression, hospitalization and deaths rate, of intensive vs standard interventions, on CPAP adherence, 2 years after CPAP initiation.
详细描述
There is limited data concerning long-term randomized clinical trials proving the long-term efficacy of intensive use, follow programs on improving CPAP use. Therefore the investigators aimed to compare the effects on sleepiness, quality of life, depression, hospitalization and deaths rate, of intensive vs standard interventions, on CPAP adherence, 2 years after CPAP initiation.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •newly diagnosed obstructive sleep apnea syndrome by polysomnography according to standard criteria,
- •with moderate to severe sleep apnea,
- •no history of previously CPAP therapy and
- •with an above-elementary school education.
排除标准
- •refusal to participate,
- •refusal to CPAP therapy,
- •previous CPAP treatment,
- •central sleep apnoea syndrome,
- •Cheyne-stokes breathing pattern,
- •obesity hypoventilation syndrome,
- •restrictive ventilator syndromes,
- •congestive heart failure,
- •history of life-threatening arrhythmias,
- •cardiomyopathy,
- •long term oxygen therapy,
- •family or personal history of mental illness,
- •with drug or alcohol abuse,
- •severe cognitive impairment,
- •concurrent oncologic diseases and
- •history of narcolepsy.
结局指标
主要结局
Effect of intensive intervention on CPAP adherence
时间窗: 24 months
次要结局
- Effect of intensive intervention on quality of life(24 months)
- Effect of intensive intervention on sleepiness.(24 months)
- Effect of intensive intervention on mood.(24 months)
研究者
Izolde Bouloukaki
Consultant family physician, Sleep Medicine subspecialty
University of Crete