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
- 1
- 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.
研究组 & 干预措施
Facial-Flex
The facial flex (FF) exerciser manufactured by Facial Concepts, Inc is an FDA approved Class I medical device for treatment of facial muscle laxity. Facial muscles tend to weaken with age. The combination of deteriorating elastic tissue and facial muscle weakness causes the face to sag. Facial flex consists of two plastic tipped curved lower bars which slide across each other. An external dynamic resistance is provided by elastic bands.
干预措施: Facial-Flex (Device)
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)