Sleep Apnea Treatment With Expiratory Resistance(Provent™)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Change in AHI
研究概览
简要总结
Continuous positive airway pressure (CPAP) continues to be the primary therapy prescribed for the treatment of obstructive sleep apnea (OSA). Although effective, adherence to CPAP is suboptimal in many patients, making alternative therapies desirable. Recently, a novel device (Provent™) has been developed for the treatment of snoring and OSA. The purpose of the current study is to examine how well the Provent™ device treats OSA with particular attention to the how the it may treat sleep apnea and who may most likely benefit from the use of this treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consenting adults over the age of 18
- •Diagnosed obstructive sleep apnea (defined as an RDI > 5 events per hour & ≥ 90% of disordered breathing events classified as obstructive)
排除标准
- •Total sleep time from previous sleep study < 4 hours (240 minutes)
- •Severe bilateral nasal obstruction (apparent mouth breathing at rest)
- •Documented history of lung diseases, as defined below:
- •Daytime hypercapnia (PaCO2 > 45 mmHg)
- •Baseline SaO2 ≤ 92%
- •Chronic lung disease except mild intermittent or mild persistent asthma
- •Cor pulmonale
- •Documented clinical cardiovascular disease, as defined below:
- •Myocardial infarction in past 3 months
- •Revascularization procedure in past 3 months
- •Implanted cardiac pacemaker or ICD
- •Unstable arrhythmias
- •Congestive heart failure with ejection fraction < 40%
- •Uncontrolled hypertension (BP > 190/110)
- •History of end stage renal disease (on dialysis)
- •History of end stage liver disease, such as:
- •History of recurrent gastrointestinal bleeding
- •Transjugular intrahepatic portosystemic shunt (TIPS) ;
- •Sleep disorders other than obstructive sleep apnea, such as:
- •Narcolepsy
- •Restless leg syndrome
- •Periodic limb movements causing an arousal index of > 5 per hour
- •Transportation industry worker (commercial truck or bus drivers, airline pilots)
- •Known pregnancy (by self report)
- •Known coagulopathy or anticoagulant use (e.g. coumadin) other than aspirin.
- •Allergy to lidocaine
结局指标
主要结局
Change in AHI
时间窗: Comparisons were made between the 2 nights
The primary outcome was the change in the apnea hypopnea index (AHI). Sleep apnea events are defined as apneas and hypopneas.The AHI is a measure of sleep apnea severity. An AHI \> 5 event/h is considered abnormal. AHI values are typically categorized as 5-15 events/hr = mild; 15-30 events/hr = moderate; and \> 30 events/hr = severe. For this study we compared the change in AHI from the baseline sleep study (No Provent) compared to the treatment night sleep study (on Provent).
次要结局
未报告次要终点
研究者
Susheel Patil
Assistant Professor of Medicine
Johns Hopkins University