SleepFlexTM Treatment of Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Number of Participants With Freedom From SleepFlex-related Serious Adverse Events
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of the SleepFlex program for treatment of mild to moderate OSA
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 21 years and older
- •Mild to moderate OSA, defined as AHI >10 - 30 events/hour, documented by polysomnogram or home sleep apnea test within 180 days prior to study enrollment
- •Central or mixed disordered breathing events (≤25% of total number of events)
- •Unable to tolerate or decline positive airway pressure therapy
- •Body mass index ≤32 kg/m2
- •Able to protrude tongue ≥20 mm beyond maxillary incisors
- •Absence of markedly enlarged tonsils, defined as 3+ or 4+ according to the Brodsky classification
- •No uncontrolled sleep disorder other than OSA such as narcolepsy, chronic insomnia, restless legs syndrome, or REM behavior disorder
- •Absence of excessive daytime sleepiness, defined by Epworth Sleepiness Scale score >10
- •No uncontrolled nasal obstruction
- •Absence of moderate to severe mandibular insufficiency
- •No previous surgery involving the oral cavity or pharynx other than tonsillectomy
- •No previous radiation therapy to the head and neck
- •No known neurologic, cardiac (other than hypertension controlled with a single medication), pulmonary, renal, hepatic, or psychiatric disorders
- •No psychiatric diagnoses other than treated depression or mild anxiety
- •Stable medication regimen for ≥1 month
- •No acute illness or infection
- •Ownership of personal smartphone with iOS or Android operating system
- •No known hypersensitivity to any material of the SleepFlex devices
排除标准
- •Unwilling or unable to provide informed written consent in English
- •Pregnancy, breastfeeding, or plans to become pregnant
- •Smoker (tobacco or recreational drugs) in the past month
- •Alcohol consumption, averaged over the previous month, greater than 2 alcoholic beverages per day
- •Significant vision or hearing problems
- •Unwilling or incapable of returning for all follow-up visits and conduct sleep studies at home, including the evaluation procedures and filling out questionnaires
- •Any other reason the investigator determines as being unfit for study participation
结局指标
主要结局
Number of Participants With Freedom From SleepFlex-related Serious Adverse Events
时间窗: 12 weeks
Number of participants with absence of serious adverse events related to the SleepFlex system.
Change in the Apnea-hypopnea Index (AHI)
时间窗: 12 weeks
Change in the apnea-hypopnea index (AHI) on post-treatment vs. pre-treatment home sleep apnea test. Apneas are defined by \>=80% reduction in airflow for \>= 10 seconds in the presence of respiratory effort. Hypopneas are defined by \>=50% reduction in airflow with oxygen desaturation of \>=3% in the presence of respiratory effort. The Apnea-hypopnea index (AHI) is the sum of the apneas and hypopneas divided by the hours of recording time. AHI values are typically categorized as 5-15/hr = mild; 15-30/hr = moderate; and \>= 30/h = severe.
次要结局
- Number of Participants With Development of Side Effects: Mouth, Throat, or Neck Pain; Dysphagia(12 weeks)