A Prospective, Observational, Post-market Surveillance Study to Evaluate the Long-term Safety and Efficacy of the iNAP® Sleep Therapy System in Adults With Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events in this entire study.
研究概览
简要总结
A Prospective, Observational, Post-market Surveillance Study to Evaluate the Long-term Safety and Efficacy of the iNAP® Lite Sleep Therapy System in Adults with Obstructive Sleep Apnea
详细描述
Obstructive sleep apnea (OSA) impacts sleep quality of patients, which contributes significantly to hypertension, stroke, myocardial infarction and other health problems. Intraoral devices, such as tongue retaining devices, palatal lifting devices and mandibular repositioning devices designed to increase the patency of the airway and to decrease airway obstruction, are used to treat OSA. To this end, we are conducting a prospective, observational, post-market surveillance study to evaluate the long-term safety and efficacy of the iNAP® Lite sleep therapy system (iNAP® Lite), a tongue and soft palate retaining intraoral device, in adults with OSA.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Diagnosed with OSA with AHI>5
排除标准
- •Patients with central sleep apnea (CSA).
- •Patients with have severe respiratory disorders such as pulmonary diseases, pneumothorax, etc.
- •Patients with loose teeth or advanced periodontal disease.
- •Patients with pathologically low blood pressure.
结局指标
主要结局
Number of participants with adverse events in this entire study.
时间窗: through study completion, up to 10 weeks
All safety events will be listed and tabulated for their occurrence rate
次要结局
- iNAP® Lite-treated clinical success rate(a treated polysomnography or polygraphy assessment night)