The Effect of the DryMouth Shield on Snoring
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Frequency of snoring
研究概览
简要总结
To measure the effect of the DryMouth Shield on snoring.
详细描述
The primary outcome of this study is to aid in the final design of the DryMouth Shield and to assess the effect of the DryMouth Shield on snoring frequency. To accomplish this we will compare the frequency of snores during 1) overnight polysomnography without using the DryMouth Shield and 2) overnight polysomnography using the DryMouth Shield. Secondary outcomes of the study will include: 1) compare the difference in the volume of snores without and with the use of the DryMouth Shield; 2) estimate the changes in apnea hypopnea index without and with the use of the DryMouth Shield; 3) describe symptoms of dry mouth without and with the use of the DryMouth Shield 4) describe symptoms of bruxism without and with the use of the dry mouth shield and 5) gather patient feedback about the user experience with the dry mouth shield.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •reports of snoring that disturbed a bed partner or housemate and
- •an objective measure of snoring such as a previous home sleep study, lab based polysomnography, or smart phone application with a snoring index of at least 20%
排除标准
- •Patient's with a body mass index of greater than 35 kilogram/meter squared.
- •A history of chronic lung disease with permanently impaired lung function testing.
- •A history of cardiovascular disease including but not limited to coronary artery disease or cerebrovascular disease.
- •Current smokers.
- •Patient's with a comorbid sleep disorder including but not limited to severe sleep apnea with an apnea hypopnea index of 30 events per hour, nocturnal hypoxia necessitating oxygen, current positive airway pressure use or restless legs syndrome
- •Poor nasal patency in the judgment of the investigator
- •Use of narcotics, benzodiazepines or other respiratory suppressing medication
- •Females who are pregnant.
研究组 & 干预措施
Snoring cohort.
Subjects will undergo two nights of polysomnography. The first night will be a baseline recording. The next night subjects will use the DryMouth Shield during the polysomnography.
干预措施: DryMouth Shield (Device)
结局指标
主要结局
Frequency of snoring
时间窗: One night
The percentage of number of snores during the sleep period relative to the total number of breaths during the same sleep period. A snore is defined as a breath during sleep accompanied by a vibratory noise louder than 40db
次要结局
- Volume of snoring(One night)
研究者
Thomas Stern, MD
Medical Director
VMS Medical Products, Inc