Effect of Upper Airway Stimulation: A Randomized Controlled Crossover Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in AHI from Baseline to Visit 1 and Visit 2
研究概览
简要总结
Upper Airway Stimulation is a new therapy, which is available for patients with obstructive sleep apnea, who are non-compliant to the standard treatment continuous positive airway pressure (CPAP) therapy. This study is a prospective, multi-center, double-blinded, randomized crossover study conducted under a common protocol. The study visits include baseline with an in-laboratory polysomnography (PSG) after six months of therapy usage, followed by visits and in-lab PSGs at 1 and 2-weeks where the Therapy stimulation will be changed at each, according to randomization. The objective of this randomized controlled crossover study is to assess treatment effect of Inspire UAS in patients at different time points with two different therapy settings. This study will provide additional clinical evidence of Inspire UAS for treatment of moderate to severe OSA using a randomized controlled crossover trial design.
详细描述
Obstructive Sleep Apnea (OSA) is characterized by recurrent episodes of airflow obstruction in the upper airway that results in oxygen desaturations and arousal from sleep. The most common symptom of OSA is excessive daytime sleepiness. Recent studies have also shown clear association of OSA with the development of obesity, hypertension diabetes mellitus, and congestive heart failure. Approximately 13% men and 6% women have moderate to severe OSA (apnea hypopnea index, AHI ≥ 15) in the US.
The efficacy of therapies for OSA, and in particular, continuous positive airway pressure (CPAP) has been limited due to patient intolerance, poor patient selection, or limited response to the therapy.
The Inspire Upper Airway Stimulation (UAS) system is intended to prevent upper airway obstruction by stimulating the hypoglossal nerve synchronous with respiration [7].
The Inspire system is comprised of the following components:
- Inspire Upper Airway Stimulator (Implantable Pulse Generator (IPG))
- Inspire Stimulation Lead
- Inspire Sensing Lead
- External programmers used with the system are:
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Neither the subject nor the investigator or Outcomes Assessor (double-blinded) will know the outcome of the randomization until after the subject has fulfilled and completed all study requirements at the end of the visit 3.
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
- •Otherwise healthy subjects that are at least 18 years old and:
- •Have been implanted and using the Inspire Therapy for at least six months
- •Willing and capable to undergo three in-lab PSGs in a one-month timeframe
- •Willing and capable of having reduced Inspire stimulation for one week
- •Willing and capable of providing informed consent
排除标准
- •Subjects who meet any of the following criteria will be excluded from this clinical investigation:
- •Unwilling to complete three in-lab PSGs within a 1-month timeframe
- •Any other reason the investigator deems subject is unfit for participation in the study
结局指标
主要结局
Change in AHI from Baseline to Visit 1 and Visit 2
时间窗: Baseline through Visit 1 (1 week) and Visit 2 (2 weeks)
Apnea Hypopnea Index (AHI) is a measure of OSA severity. The AHI in this study will be determined by the AHI score at Visit 1 and Visit 2 compared with the baseline score.
Change in ESS from Baseline to Visit 1 and Visit 2
时间窗: Baseline through Visit 1 (1 week) and Visit 2 (2 weeks)
The Epworth Sleepiness Scale (ESS) is a validated instruction that rates a subject's daytime sleepiness. The ESS efficacy endpoint will be determined by the ESS score at Visit 1 and Visit 2 as compared to baseline.
次要结局
- Therapy Adherence(Baseline through Visit 1 (1 week) and Visit 2 (2 weeks))
- Change in ODI from Baseline to Visit 1 and Visit 2(Baseline through Visit 1 (1 week) and Visit 2 (2 weeks))
- Change in Clinical Global Impression (CGI-I) from Baseline to Visit 1 and Visit 2(Baseline through Visit 1 (1 week) and Visit 2 (2 weeks))
- Change in FOSQ from Baseline to Visit 1 and Visit 2(Baseline through Visit 1 (1 week) and Visit 2 (2 weeks))
- Change in Snoring Intensity from Baseline to Visit 1 and Visit 2(Baseline through Visit 1 (1 week) and Visit 2 (2 weeks))