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: 2015年4月15日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方: Apnex Medical, Inc.
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

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

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: 否

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

发起方

Apnex Medical, Inc.

申办方类型

Industry

责任方

Sponsor

研究点 (7)

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