NCT02180815终止不适用
ReVENT Sleep Apnea System, a Minimally Invasive Approach to Treat Obstructive Sleep Apnea: a Prospective Multicenter Post-Market Observational Study
Revent Medical International B.V.14 个研究点 分布在 5 个国家目标入组 50 人开始时间: 2014年9月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 50
- 试验地点
- 14
- 主要终点
- Reduction in Apnea-Hypopnea Index (AHI)
研究概览
简要总结
The purpose of this post-market observational study is to assess the effectiveness and patient perception of benefit of the ReVENT Sleep Apnea System in patients diagnosed with Obstructive Sleep Apnea due to primary tongue base closure. The ReVENT Sleep Apnea System is a minimally invasive surgical approach to treat Obstructive Sleep Apnea. The ReVENT Sleep Apnea System consists of an implanter kit and tongue implants. The implants are permanently implanted in the tongue during a minimally invasive outpatient surgical procedure to prevent tongue base closure during sleep.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patient diagnosed with Obstructive Sleep Apnea due to primary tongue base closure.
- •AHI ≥ 10 and AHI ≤ 40 (at least 90% of apneas and hypopneas must be obstructive).
- •Confirmation of tongue base closure as the primary source of obstruction with Drug Induced Sleep Endoscopy (DISE).
排除标准
- •Patient with prior tongue-base surgery
- •Uvulopalatopharyngoplasty, soft palate surgery, tonsillectomy or minimally invasive RF ablation of the tongue within the last six (6) months.
- •History of mandibular and/or hyoid advancement to treat OSA.
- •Any contraindications as listed in the approved Instructions for Use.
结局指标
主要结局
Reduction in Apnea-Hypopnea Index (AHI)
时间窗: 3, 6 and 12 months
次要结局
- Patient perception of benefit as measured by change in daytime sleepiness and sleep-related quality of life(3, 6 and 12 months)
研究者
研究点 (14)
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