NCT03264963已完成不适用
Upper Airway Training for Treatment of Snoring Using Smartphone Application
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 主要终点
- Snoring Intensity
研究概览
简要总结
The objective of this study is to reduce the incidence or intensity of snoring in a patient population of known simple snorers without sleep apnea using smartphone based application which allows participants to play voice controlled games using various articulations resulting in tongue base movements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fluent in English.
- •Age is between 20 and
- •BMI less than 32
- •Less than 5% variance in weight since sleep study.
- •Snoring without health risk related to sleep apnea and not currently receiving treatment.
- •Mild OSA or negative HSAT or PSG within past year with AHI 0-14
- •Has refused oral appliances, CPAP, weight loss, surgery or positional therapy.
- •Owns an iPhone 4 or newer and is comfortable downloading and using apps.
- •Complaint of habitual snoring 3 or more nights per week
- •Rated by polysomnograph technologist as moderate or loud snoring.
排除标准
- •Non-fluent in English.
- •Persistent rhinitis diagnosis or nasal obstruction.
- •Greater than 5% variance in weight since sleep study.
- •Diagnosis of moderate to severe sleep apnea or any other sleep disorder (insomnia, RLS)
- •Insufficient sleep, defined as getting fewer than 6 hours of sleep on an average night based on self report.
- •Spouse/partner is also a habitual snorer.
- •Lacking ability to consent for themselves.
- •Heavy drinker (self reported average more than 2 drinks per day).
- •Regular narcotics (greater than 3 times/week)
- •Epworth sleepiness scale score > 11 or one near miss accident in the past 6 months.
- •Medical conditions as follows: symptomatic cardiopulmonary disease, chronic renal insufficiency, poorly controlled mental illness.
研究组 & 干预措施
Control
Active Comparator
干预措施: Control (Other)
Intervention
Experimental
干预措施: Smart phone game play (Other)
结局指标
主要结局
Snoring Intensity
时间窗: 12 weeks
Snoring sounds \>60 db
Snoring Rate
时间窗: 12 weeks
Snoring sounds/hour of sleep
次要结局
- Sleepiness(12 weeks)
- Sleep Quality(12 weeks)
- Bed Partner Sleep Quality(12 weeks)
研究者
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