NCT07303452招募中不适用
A Multi-center Proof-of-concept Study to Assess the Safety and Effectiveness of the Restera™ Serene™ System When Stimulating the Hypoglossal Nerve Alone or the Hypoglossal Nerve Plus the Ansa Cervicalis Nerve for the Treatment of Obstructive Sleep Apnoea in Adult Participants.
Restera, Inc.1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年12月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Safety of the Restera Serene System
研究概览
简要总结
The purpose of this multi-center proof-of-concept safety and efficacy study is to collect chronic sleep-related data following percutaneous placement of electrode arrays near the hypoglossal nerve and the ansa cervicalis in adults with obstructive sleep apnea.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Body Mass Index (BMI) ≤ 32 kg/m2
- •AHI between 15-65 events/hour
- •Participants who have either not tolerated, have failed or refused positive airway pressure (PAP)
排除标准
- •Pregnancy or breast-feeding
- •Significant upper airway anatomic abnormalities
- •Significant positionally-dependent OSA
- •Participants taking medications that may alter body weight
结局指标
主要结局
Safety of the Restera Serene System
时间窗: 6 months
Incidence of device and/or procedure-related serious adverse events
Effectiveness of the Restera Serene System
时间窗: 6 months
Change from baseline in the Apnea-Hypopnea Index
次要结局
- Long-term Safety of the Restera Serene System(36 months)
- Long-term Effectiveness of the Restera Serene System(36 months)
研究者
研究点 (1)
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