High Flow Nasal Cannula as a Treatment for Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 主要终点
- Apnea Hypopnea Index (AHI)
研究概览
简要总结
A single center, prospective study to assess the efficacy of high flow nasal cannula (HFNC) in improving obstructive sleep apnea (OSA) parameters in patients with reduced tolerance to continuous positive airway pressure (CPAP) treatment.
详细描述
A single center, prospective study. The study would include 30 patients diagnosed within the past 2 years with moderate to severe OSA (AHI>=15) at the Rabin Medical Center (RMC) sleep lab, and who are intolerant to CPAP treatment. Following signing an informed consent form, these patients would undergo polysomnography (PSG) while treated with HFNC. The HFNC PSG outcome measures will be compared to the baseline PSG done within the past 2 years and to an additional PSG while connected to a CPAP device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years
- •Confirmed diagnosis of obstructive sleep apnea, diagnosed at RMC sleep lab in the past 2 years
- •Apnea Hypopnea Index (AHI)≥15
- •Patient has difficulties to adjust or comply with CPAP treatment
- •Signed Informed Consent Form
排除标准
- •Patients who need bilevel positive airway pressure (BIPAP)
- •Known carbon dioxide (CO2) retainers
- •Weight change>10% compared to time of OSA diagnosis
- •Clinically unstable patients
- •Pregnant women or special populations (e.g. children or patients unable to give informed consent)
结局指标
主要结局
Apnea Hypopnea Index (AHI)
时间窗: During at least 2 hours of sleep time
Comparison of HFNC AHI to baseline AHI and to CPAP AHI
次要结局
- Minimal SO2%(During at least 2 hours of sleep time)
- Percent of hypoxemia time(During at least 2 hours of sleep time)
- Sleep efficiency(During at least 2 hours of sleep time)
- Adverse events reported while using HFNC(During at least 2 hours of sleep time)
- Total sleep time(During at least 2 hours of sleep time)
研究者
Mordechai Kremer
Head of Pulmonary Institute
Rabin Medical Center