A Prospective, Randomized, Crossover Study of the NightBalance Sleep Position Trainer (SPT) Compared to Automatic Adjusting Positive Airway Pressure (APAP) for the Treatment of Positional Obstructive Sleep Apnea (POSA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 117
- 试验地点
- 22
- 主要终点
- Adherence (minutes of device use per night)
研究概览
简要总结
This study is a prospective, multi-center, randomized crossover of the NightBalance SPT compared to APAP for the treatment of Positional Obstructive Sleep Apnea (POSA).
详细描述
This study is a prospective, multi-center, randomized crossover of the NightBalance SPT compared to APAP for the treatment of POSA.
The Primary Objective of the study is to demonstrate non-inferiority of treatment with the SPT as compared to APAP.
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)
盲法说明
The technician scoring the polysomnograms will be unaware of previous PSG results from the patient to the best of their ability (ie: will not look back in their records for the purpose of reviewing their previous PSGs prior to scoring).
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is between the ages of 20 and
- •Diagnosis of POSA meeting all the following criteria per in-lab control PSG (performed within 3 months of screening):
- •Total AHI >15, or AHI >10 and <15 with ESS >10
- •Supine AHI at least twice the non-supine AHI
- •Non-supine AHI <10 (<5 in mild patients)
- •Supine time >40% and <60%
- •Subject understands the study protocol and is willing and able to comply with study requirements and sign informed consent.
排除标准
- •Prior surgery to treat OSA (such as UPPP), or prior or current therapy or treatment for OSA, with the exception of PAP being used for split night PSG only.
- •A female of child-bearing potential that is pregnant or intends to become pregnant.
- •Any unstable or severe medical condition of any organ system including congestive heart failure, COPD, renal failure, neuromuscular disease, or at the discretion of the site Principal Investigator (PI).
- •Taking medication that may affect sleep, sleepiness, or alertness including hypnotics, sedatives, alerting agents, stimulants, opiates, sedating antidepressants, and anticonvulsants.
- •Oxygen use.
- •The presence of any other sleep disorder (central sleep apnea (CSA >5), periodic limb movement disorder (PLMAI >15), clinical diagnosis of insomnia or narcolepsy).
- •Excessive alcohol consumption (>21 drinks/week).
- •The use of any illegal drug(s).
- •Night or rotating shift work.
- •Severe claustrophobia.
- •Shoulder, neck, or back complaints that restrict sleeping position.
- •Subject requires use of more than 2 pillows under the head while sleeping or sleeps in a bed/chair with raised upper body position.
结局指标
主要结局
Adherence (minutes of device use per night)
时间窗: 6 week
Non-inferiority of SPT vs. APAP (calculated by number of minutes of objective device use per night)
Apnea-Hypopnea Index (AHI, events/hr)
时间窗: 6 week
Non-inferiority of SPT vs. APAP (measured by events/hr during in lab polysomnography)
次要结局
- Total Sleep Time (minutes)(6 week)
- Sleep Efficiency (%)(6 week)
- Epworth Sleepiness Scale (ESS)(6 week)
- Patient Satisfaction (Comfort, Satisfaction) assessed by Visual Analog Scale (VAS)(6 week)
- Functional Outcomes of Sleep Questionnaire (FOSQ)(6 week)
- SF-36(6 week)
- Oxygen Desaturation Index (3%)(6 week)
- Adverse Events(6 weeks)
- Sleep Onset Latency (minutes)(6 week)
- Arousal Index(6 week)
- Sleep Stages (%)(6 week)
- Sleep Position (%)(6 week)
- Mean Disease Alleviation (MDA) (%)(6 weeks)