Is Adaptive Servo-Ventilation Therapeutically More Effective Than Continuous Positive Airway Pressure In Treating Complex Sleep Apnea Syndrome?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ResMed
- 入组人数
- 66
- 试验地点
- 12
- 主要终点
- Apnea-hypopnea Index (AHI) Per Polysomnography (PSG) at the End of Treatment Period
研究概览
简要总结
The purpose of this study is to determine whether adaptive servo-ventilation (ASV) or continuous positive airway pressure (CPAP) is better at treating complex sleep apnea over time.
详细描述
Between 3 and 19% of patients with clinical and polysomnographic features of obstructive sleep apnea syndrome (OSA) develop a high-frequency of central apneas and/or disruptive Cheyne-Stokes respiratory syndrome after application of continuous positive airway pressure (CPAP), a pattern called the complex sleep apnea syndrome (CompSAS). The trial seeks to determine the efficacy of the ASV vs. CPAP modes for the treatment of CompSAS over time. Baseline clinical and laboratory data will be collected, patients will be randomized to one of the two treatments. Overall study participation is approximately 3 months.
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
- Double (Participant, Outcomes Assessor)
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
- •Diagnosis of complex sleep apnea syndrome (CompSAS)
- •Naive to PAP therapy
- •Requires CPAP ≤15 cm H2O
排除标准
- •Requires supplemental oxygen or with a baseline SaO2 <90%
- •Requires CPAP > 15 cm H2O
- •Primary diagnosis of moderate to severe chronic obstructive pulmonary disease, neuromuscular disease, chronic hyperventilation, stroke, cognitive impairment, such that could impair ability to answer subjective questions (study questionnaires) or unstable heart failure
- •Any contraindication for nasal or oro-nasal positive airway pressure, such as claustrophobia, severe nasal obstruction, or impaired mental status
结局指标
主要结局
Apnea-hypopnea Index (AHI) Per Polysomnography (PSG) at the End of Treatment Period
时间窗: 3 months
AHI refers to the number of apneas and hypopneas that occurred per hour of sleep
次要结局
- Quality of Life Measured by the Sleep Apnea Quality of Life Index (SAQLI)(3 months)