Adherence to Electrical Glossal In Situ Stimulation for Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Mean Number of Days Device Was Used
研究概览
简要总结
The purpose of this research is to assess how well people with mild obstructive sleep apnea (OSA) adhere to the eXciteOSA device and specifically examine whether adherence of the device is different with low versus high electrical stimulation. In addition, this research study will assess how well the device affects mild sleep apnea and if it improves sleepiness and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than 18 years
- •Ability to consent
- •Home sleep apnea test demonstrating mild obstructive sleep apnea.
- •Smartphone or tablet
排除标准
- •Current pacemaker, defibrillator, or neuro-stimulation device
- •No prior oropharyngeal surgery for sleep apnea
- •No implants, metal prostheses, dental braces, or soft tissue/bony ulcerations in the oral cavity
- •No prior use of mandibular advancement device (MAD) or continuous positive airway pressure (CPAP)
- •Heart failure (New York Heart Association Class 3 or 4; or ejection fraction < 45%)
- •Active coronary disease defined as an intervention (e.g., angioplasty, coronary artery bypass surgery) in the prior 6 months
- •Uncontrolled hypertension (BP > 160/100)
- •Clinician diagnosis of any chronic lung disease except asthma
- •Chronic fatigue syndrome or fibromyalgia
- •Self-reported current illicit drug use in the past 30 days
- •Self-reported use of marijuana or opiates in the past 30 days
- •Use of supplemental oxygen
- •Self-reported use of prescribed or over the counter sleeping medications in the past 30 days
- •Current pregnancy or intention of becoming pregnant
- •Oropharyngeal abnormalities (class 2 or class 3 malocclusion)
- •Periodic breathing (Cheyne Stoke respiration)
- •Central sleep apnea (central apnea index (CAI) > 5/h)
- •Investigator discretion
研究组 & 干预措施
Low intensity application of eXciteOSA
Participants will receive the eXciteOSA device intervention at low intensity application for 20 minutes per day for 6 consecutive weeks.
干预措施: eXciteOSA (Device)
High intensity application of eXciteOSA
Participants will receive the eXciteOSA device intervention at high intensity application for 20 minutes per day for 6 consecutive weeks.
干预措施: eXciteOSA (Device)
结局指标
主要结局
Mean Number of Days Device Was Used
时间窗: Up to 6 weeks
Adherence level will be reported as the mean number of days the eXciteOSA device was used.
次要结局
- Quality of Life as Measured by EuroQol Score(Up to 6 weeks)
- Number of Participants Accepting Long Term Treatment(6 weeks)
- Work Productivity and Activity Impairment (WPAI) Questionnaire Scores(Up to 6 weeks)
- Snoring Visual Analog Scores(Up to 6 weeks)
- Epworth Sleepiness Scale (ESS) Scores(Up to 6 weeks)
- Mean Respiratory Event Index (REI)(Up to 6 weeks)
- Pittsburgh Sleep Quality Index (PSQI)(Up to 6 weeks)
- Short Form-20 (SF-20) Scores(Up to 6 weeks)
研究者
Naresh Punjabi
Professor of Clinical
University of Miami