The Use of Heliox in Obstructive Sleep Apnea Syndrome.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Lowest Oxygen Saturation (L SO2)
研究概览
简要总结
The goals of the project is to evaluate the effects of Heliox therapy on obstructive sleep apnea syndrome (OSAS).
详细描述
Obstructive sleep apnea syndrome (OSAS) is a common condition affecting up to 2-4 % of the general population. The pathophysiologic consequences of OSA include: excessive daytime sleepiness leading to increased car and work related accidents; and increased incidence of hypertension (HTN), stroke and possibly coronary artery events. In addition, patients with severe and untreated obstructive sleep apnea (OSA) have increased mortality compared to patients with treated severe OSA.The main stay of treatment of OSAS is the application of continuous positive airway pressure (CPAP) during sleep. The main problem with CPAP therapy is compliance. Heliox, a mixture of oxygen and helium has been used for many years in the treatment of upper airway obstruction. In this study, the investigators will evaluate the effectiveness of Heliox in the treatment of OSAS. Adult subjects with the diagnosis of obstructive sleep apnea syndrome who are referred for repeat sleep study for CPAP titration will be evaluated.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 18 or older with obstructive sleep apnea syndrome (OSAS) presenting for CPAP titration.
排除标准
- •Professional singers.
- •Television or Radio hosts.
- •Disk Jockeys.
- •Subjects requiring oxygen therapy.
- •Subjects younger than 18 year old.
- •Pregnant women.
- •Patients with chronic obstructive pulmonary disease (COPD) with forced expiratory volume 1 (FEV1) less than 50%.
- •History of anatomic upper airway obstruction.
- •Uncontrolled asthma.
研究组 & 干预措施
Heliox
Heliox which is a mix of oxygen and helium gase will be administered through a face mask during part of the sleep study.
干预措施: Heliox (Drug)
结局指标
主要结局
Lowest Oxygen Saturation (L SO2)
时间窗: Baseline and in 6-8 hours.
Assessment of L SO2 at baseline ( without heliox) and after 6-8 hours of sleep with heliox.
Apnea Hypopnea Index
时间窗: Baseline and in 6-8 hours. The reported data are at baseline ( without heliox) and after 6-8 hours of sleep with heliox.
Assessment of Apnea/Hypopnea Index (AHI) at baseline ( without heliox) and after 6-8 hours of sleep with heliox.
Apnea Index (AI)
时间窗: Baseline and in 6-8 hours. The reported data are at baseline ( without heliox) and after 6-8 hours of sleep with heliox.
Assessment of Apnea Index (AI) at baseline ( without heliox) and after 6-8 hours of sleep with heliox.
Mean Oxygen Saturation (M SO2)
时间窗: Baseline and in 6-8 hours.
Assessment of M SO2 at baseline ( without heliox) and after 6-8 hours of sleep with heliox.
次要结局
未报告次要终点
研究者
Michel Chalhoub
Principal Investigator
Northwell Health