跳至主要内容
临床试验/NCT01211444
NCT01211444已完成2 期

US Prospective Clinical Study of the Apnex Medical Hypoglossal Nerve Stimulation (HGNS) System to Treat Obstructive Sleep Apnea

Apnex Medical, Inc.7 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2010年7月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
20
试验地点
7
主要终点
Mean change in AHI measured with in-lab nighttime polysomnography (PSG) compared to baseline

研究概览

简要总结

The overall goal of the study is to evaluate the safety, efficacy and therapy settings of the Hypoglossal Nerve Stimulation (HGNS) System for stimulating the hypoglossal nerve to help maintain airway opening in subjects with Obstructive Sleep Apnea (OSA).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
21 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Mean change in AHI measured with in-lab nighttime polysomnography (PSG) compared to baseline

时间窗: 6 months post-implant

Mean change in functional outcomes measured with the Functional Outcomes Sleep Questionnaire (FOSQ) compared to baseline

时间窗: 6 months post-implant

The frequency of serious adverse events.

时间窗: 6 months post-implant.

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (7)

Loading locations...

相似试验