Facial-Flex as a Treatment for Snoring
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Snore Index
研究概览
简要总结
The study will test the hypothesis that training with the Facial-Flex exercise device for six weeks will improve snoring in patients with primary snoring or very mild sleep apnea.
详细描述
Subjects will be studied before and after 6 weeks of Facial-Flex training using portable monitoring. There will be 8 patient visits and 2 additional trips to the sleep center to return the portable sleep monitor.
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
- 是
入选标准
- •Patients with a history of loud snoring but no observed breathing pauses by bed partner (or only very mild obstructive sleep apnea on a previous sleep study within the prior year) will be enrolled.
- •Very mild sleep apnea is defined here as an apnea-hypopnea index (AHI) < 10/hour).
- •This assumes that the AHI is computed using hypopnea defined as a 30% drop in the flow signal associated with a 4% or greater arterial oxygen desaturation.
排除标准
- •Prior upper airway surgery
- •Daytime sleepiness (Epworth sleepiness scale >12/24), (obesity BMI > 35 kg/M2)
- •Significant arterial oxygen desaturation defined as 5 minutes or more with an arterial oxygen desaturation less than 88%
- •Severe insomnia with less than 4 hours of sleep per night
- •Uncontrolled psychiatric disorder
- •Any disorder causing facial weakness
- •Pregnancy
- •Temporal mandibular joint problems.
结局指标
主要结局
Snore Index
时间窗: baseline and after 6 weeks of facial muscle training
The snore index is the number of snores per hour of monitoring. The pre-treatment and post-treatment (6 weeks) values will be compared. A snore is a vibratory noise usually noted during inspiration and associated with vibration of the uvula and palate. The snore sensor in this study is the nasal pressure cannula connected to a sensitive pressure transducer. Snoring is detected as a fine (high frequency) oscillation superimposed on the nasal pressure waveform. The device \[Sleep Scout (ClevMed, Cleveland Ohio)\] has an automated scoring detection algorithm to identify breaths with snoring. Each breath with vibration is counted as a snore. As the algorithm is automated and the same snore threshold was used for both baseline and 6 week sleep studies, this prevents technologist bias in detecting snores (breaths with vibration).
次要结局
- Apnea-Hypopnea Index (AHI)(baseline and after 6 weeks of facial muscle training)