ACTRN12615000028505已完成1 期
A prospective, single arm, single centre pilot trial to establish the safety and efficacy of the Oventus device to treat mild to moderate obstructive sleep apnoea and snoring.
Oventus Pty Ltd0 个研究点目标入组 30 人开始时间: 2015年1月19日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Age equal to or greater than 18, mild to moderate AHI (between 5-30), eligible to receive a mandibular advancement device, grade 2-3 snoring, intact top row of teeth, able top provide written consent and adhere to protocol requirements.
排除标准
- •Pregnant or lactating females, participating in another clinical trial, periodontal disease, exaggerated gag reflex, medication usage that could influence respiration or sleep, obstructive sleep apnoea with uncontrolled or untreated cardiovascular disease, central sleep apnoea events greater than 5 per hour.
研究者
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