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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1日最近更新:
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适应症
干预措施

试验速览

阶段
2 期
状态
已完成
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研究组 & 干预措施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

  • •Eligibility Criteria
  • •Previously diagnosed with moderate to severe obstructive sleep apnea.
  • •Subject has failed or does not tolerate CPAP treatment.
  • •Age between 21 and 70 years.
  • •Body mass index (BMI) less than or equal to 40

排除标准

  • 未提供

研究组 & 干预措施

HGNS Treatment

Experimental

干预措施: HGNS Treatment (Device)

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

申办方类型
Industry
责任方
Sponsor

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