临床试验/NCT03375905

NCT03375905已完成不适用

Pilot Study to Evaluate the Effectiveness and Safety of the aerSleep™ System in an Ethnic Japanese Population Diagnosed With Obstructive Sleep Apnea (OSA)

Sommetrics, Inc.2 个研究点分布在 1 个国家目标入组 8 人开始时间: 2017年12月7日最近更新: 2019年9月19日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Sommetrics, Inc.
入组人数: 8
试验地点: 2
主要终点: proportion of sustained responders

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 aim of this study is to evaluate the effectiveness and safety of cNEP (continuous negative external pressure) for the treatment of obstructive sleep apnea during two weeks of home use in subjects of Japanese ethnicity.

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: 18 Years 至 70 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•both parents ethnically Japanese, or one parent Japanese and the other east-Asian
•PSG (polysomnogram) done within the previous 12 months that shows an AHI of 10-50/hr and <80% of apneas and hypopneas are obstructive
•cNEP collar fits and is well-tolerated
•Key exclusion Criteria:
•abnormalities in neck structure
•sleep disturbance other than obstructive sleep apnea
•serious medical illness
•pregnancy

排除标准

未提供

结局指标

主要结局

proportion of sustained responders

时间窗: two weeks after initiation of treatment

reduction of AHI of \>50% and to \<15/hr from qualifying PSG

次要结局

proportion of initial responders(at PSG 1, one day)
CGI of satisfaction with the cNEP device(after two weeks of treatment)
ODI comparison with qualifying PSG(one day, on three separate study occasions)
AHI comparison with qualifying PSG(one day, on three separate study occasions)
SpO2 <90% comparison with qualifying PSG(one day, on three separate study occasions)
CGI of sleep(three months, and two weeks, respectively)
Treatment-emergent adverse events(two weeks)

研究者

发起方

Sommetrics, Inc.

申办方类型

Industry

责任方

Sponsor

研究点 (2)

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