临床试验/NCT01186926

NCT01186926已完成2 期

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

Apnex Medical, Inc.0 个研究点目标入组 40 人开始时间: 2009年3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: 40
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 HGNS System for stimulating the hypoglossal nerve to help maintain an open airway 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

Adverse event profile interoperatively, perioperatively, and long term post implant

时间窗: 1, 3, 6, 12, 24, and 36 months post implant

次要结局

Mean change in functional outcomes measured with the Functional Outcomes of Sleep Questionnaire (FOSQ) compared to baseline(6 months post-implant)

研究者

发起方

Apnex Medical, Inc.

申办方类型

Industry

责任方

Sponsor

相似试验

已完成

2 期

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

NCT01211444Apnex Medical, Inc.20

已完成

不适用

Evaluation of the Clinical Performance of Apneal®, a Medical Device on Smartphone, for Sleep Apnea-hypopnea Syndrome Diagnosis.Sleep Apnea Syndromes

NCT06474143Institut National de la Santé Et de la Recherche Médicale, France491

已完成

不适用

Validation of the ApneaLink Sleep Screener for Obstructive Sleep Apnea (OSA)Obstructive Sleep Apnea

NCT00354614ResMed81

Unknown

4 期

A Prospective Safety and Effectiveness Study of a New High Repetition Rate Excimer Laser Using LASIK for the Correction of Ammetropia and PresbyopiaHyperopiaPresbyopiaMyopia

NCT02112968Technolas Perfect Vision GmbH97

Unknown

4 期

A Prospective Safety and Effectiveness Study of the 500 Hz Technolas Perfect Vision Excimer Laser in Asian Eyes Using LASIKMyopiaHyperopiaPresbyopia

NCT01977807Technolas Perfect Vision GmbH100