Investigation of a Novel Sleep Surface for Treatment of Positional Sleep Apnea.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Apnea-hypopnea Index (AHI)- Intention to Treat Analysis
研究概览
简要总结
Body position during sleep influences the severity of obstructive sleep apnea (OSA). The AHI is the number of times per hour of sleep that the airway temporarily collapses at the level of the tongue or soft palate. In a significant number of individuals with OSA, the severity of the condition as measured by the apnea-hypopnea index (AHI), increases in the supine (back) position and lowers in the lateral (side) position. This is called positional OSA.
The primary objective of this study is to determine whether sleeping with a novel sleep surface (Wave sleep surface) that is used on top of a regular bed reduces the AHI in those with positional OSA.
详细描述
The primary objective of this study is to determine whether sleeping with the novel device (Wave sleep surface) reduces the AHI in those with supine position-related OSA, also known as positional OSA. A secondary aim is to determine the effects of the sleep surface on subjective and objective measures of sleep in patients with positional OSA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (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
- •We will recruit subjects who are:
- •18 years of age and above
- •Willing and able to give informed consent
- •Prior sleep study done based on previous clinical evaluation by the subject's treating physician in the course of usual clinical care and performed no more than 12 months prior to enrollment that meets the following:
- •overall AHI 5-30 events/hr
- •at least 20 minutes of recorded sleep in the supine and nonsupine postures
- •positional OSA defined as > 50% reduction in the AHI between the supine and nonsupine postures and AHI < 5hr in the nonsupine position
- •central apneas < 50% of the total number of apneas and hypopneas
- •Patients who meet the above criteria who have been prescribed CPAP therapy but are non-compliant will be enrolled in the study. CPAP noncompliance will be defined as average nightly use < 4hrs/night based on a download of the CPAP machine, or self- acknowledged discontinuation of CPAP use.
排除标准
- •Incapable of giving informed consent
- •Under the age of 18
- •Known inability to sleep in the lateral position
- •Active titration of medication
- •Excessive alcohol consumption
- •Excessive alcohol use is defined as:
- •More than 3 glasses of wine a day
- •More than 3 beers a day
- •More than 60 mL of hard liquor a day
- •Room air oxyhemoglobin saturation < 88%
- •Use of home oxygen
- •Compliant with OSA therapy
- •Presence of severe daytime sleepiness defined as an Epworth sleepiness scale score > 16 or a prior history of falling asleep while driving
- •Unstable medical problem such as uncontrolled hypertension.
- •Body Mass Index (BMI) > 45 kg/m2
研究组 & 干预措施
Wave Surface, Then Non Wave Surface
Subjects sleep first for a whole night in the sleep laboratory with the Wave sleep surface. They then return to the sleep laboratory and sleep without the Wave sleep surface.
干预措施: Wave sleep surface (Other)
Non Wave Surface, Then Wave Surface
Subjects sleep first for a whole night in the sleep laboratory without the Wave sleep surface. They then return to the sleep laboratory and sleep with the Wave sleep surface.
干预措施: Wave sleep surface (Other)
结局指标
主要结局
Apnea-hypopnea Index (AHI)- Intention to Treat Analysis
时间窗: measured during each of the two sleep study sessions (Study Visits 2 and 3)
AHI, or the apnea-hypopnea index, is a numerical measure that accounts for the number of pauses in your breathing per hour of sleep. These breathing disturbances are typically associated with either a brief arousal or awakening from sleep or a 4 percent drop in the blood oxygen levels, called a desaturation. It is used to assess the severity of an individual's sleep apnea. This is measured in each study participant when sleeping with the Wave Sleep Surface and sleeping without the Wave Sleep Surface.
次要结局
- Objective Sleep Quality(measured during each of the two sleep study sessions (Study Visits 2 and 3))
- Sleep Efficiency(measured during each of the two sleep study sessions (Study Visits 2 and 3))
研究者
Ulysses Magalang MD
Professor of Medicine
Ohio State University