NCT01772017终止不适用
A Multi Center, Open Label Study to Evaluate a Tongue Advancement Retainer Device in the Treatment of Subjects With Obstructive Sleep Apnea and Snoring (OPEN Trial)
Sleepy, Inc6 个研究点 分布在 2 个国家目标入组 15 人开始时间: 2012年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 15
- 试验地点
- 6
- 主要终点
- Primary Safety Endpoint - The safety of the device will be measured through recorded observations of adverse events.
研究概览
简要总结
To evaluate the safety and efficacy of the Tongue Advancement Retainer Device in treating subjects with Obstructive Sleep Apnea (OSA) and snoring.
详细描述
The Tongue Advancement Retainer Device is a device that was developed to treat subjects with OSA and snoring. The purpose of this study is to evaluate initial safety and effectiveness of this device in treating one or both conditions.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Aged 18-65
- •AHI greater than or equal to 10 but less than or equal to 60 (<10 AHI <60/hr)
- •Complete set of lower anterior incisors with no evidence of periodontal disease or mobility and the ability to floss between teeth
- •Additionally subjects will in the screening phase must:
- •Tolerate the device when being fitted
- •Used the device for >4 hours on at least two consecutive nights during the screening period.
- •Be able to reliably demonstrate proper installation of the device after fitting.
- •Be willing to trial the device for a 4 week period
排除标准
- •• Central sleep apnea events >10% of the total events
- •Evidence of Cheyne stokes breathing
- •Currently on treatment for OSA or OSA treatment discontinued less than 3 months prior.
- •Currently on regular treatment with prescription hypnosedatives or prescription stimulants
- •Very severe OSA, defined as AHI>60/hour and/or minimum oxygen saturation <75%
- •Need for immediate initiation of treatment as assessed by physician (e.g. Excessive sleepiness posing driving risk)
- •Previous surgery to treat OSA (other than nasal surgery)
- •Evidence of periodontal disease or tooth mobility
- •Severe nasal obstruction or enlarged tonsils based on clinical assessment
- •Unstable cardiovascular disease (untreated hypertension acceptable).
- •Inability to tolerate oral device due to oral condition or claustrophobia as determined by the study investigator
- •Pregnant/Breast Feeding
- •Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as co-existent other sleep disorder, psychiatric disease, history of non compliance to medical regimens, or unwillingness to comply with study requirements.
结局指标
主要结局
Primary Safety Endpoint - The safety of the device will be measured through recorded observations of adverse events.
时间窗: Approximately 6 weeks
Safety endpoint will be measured throughout the duration of the study.
次要结局
- Primary Efficacy Endpoint - Change in the overall Apnea Hypopnea Index (AHI) from the PSG at baseline and end of treatment phase.(Approximately 6 weeks)
研究者
研究点 (6)
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