Evaluation of an Early Management Strategy for Obstructive Sleep Apnea: A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 2
- 主要终点
- Positive airway pressure adherence
研究概览
简要总结
The primary objective of this study is to evaluate the effect of more timely care for obstructive sleep apnea (OSA) on adherence to positive airway pressure (PAP) therapy at three months after treatment initiation. The secondary objectives are to determine if earlier care improves the treatment effect of PAP on patient reported sleepiness, quality of life and patient satisfaction. We will also evaluate the impact of shorter wait times on patient engagement in therapy by assessing initial acceptance of PAP therapy, patient activation and self-efficacy with respect to OSA treatment.
The study hypothesis is that the early management strategy will be superior to usual care with respect to the primary outcome of PAP adherence at three months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HSAT ODI >= events/hr and ESS 10 - 15 OR
- •HSAT ODI 15 - 30 and ESS 15 or lower
排除标准
- •Severe nocturnal hypoxemia on HSAT (mean oxygen saturation by pulse oximetry (SpO2) ≤ 85%)
- •Severe hypersomnolence (Epworth Sleepiness Scale score ≥ 16)
- •Employed in safety-critical occupation
- •Recent motor vehicle collision reported on screening questionnaire (within one year)
- •Severe hypertension requiring ≥ three antihypertensive medications
- •Recent admission to hospital due to unstable cardiopulmonary disease (within 30 days)
- •Upcoming major surgery (within six months)
- •Prior history of OSA treatment
- •Significant co-morbid sleep disorder that would interfere with PAP acclimatization and adherence (e.g., severe insomnia, restless leg syndrome)
研究组 & 干预措施
Early Management
Scheduled for sleep physician appointment within 1 month of home sleep apnea test/triage
干预措施: Early Management (Other)
Usual Care
Scheduled for sleep physician appointment approximately 6 months after home sleep apnea test/triage
结局指标
主要结局
Positive airway pressure adherence
时间窗: 3 months after treatment initiation
Mean number of hours of positive airway pressure use per night in the four weeks prior to three month follow-up
次要结局
- Self-efficacy: Self-Efficacy Measure for Sleep Apnea score(3 months after treatment initiation)
- Adherent to positive airway pressure(3 months after treatment initiation)
- General health-related quality of life: Change in EuroQoL-5D-3L(3 months after treatment initiation)
- Patient satisfaction: Visit-Specific Satisfaction Instrument total score(3 months after treatment initiation)
- Positive airway pressure therapy initiation(1 week after sleep physician visit)
- Disease-specific health-related quality of life: Change in Sleep Apnea Quality of Life Index(3 months after treatment initiation)
- Sleepiness(3 months after treatment initiation)
- Patient activation level(3 months after treatment initiation)
- Patient activation(3 months after treatment initiation)