A Prospective, Self-controlled, First-night Order Cross-over and Evaluator-blind Pivotal Study to Evaluate the Efficacy and Safety of the iNAP® Sleep Therapy System in Adults With Obstructive Sleep Apnea (OSA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- iNAP®-treated response rate over the apnea-hypopnea index (AHI)*
研究概览
简要总结
A Prospective, Self-controlled, First-night Order Cross-over and Evaluator-blind Pivotal Study to Evaluate the Efficacy and Safety of iNAP® Sleep Therapy System in Adults with Obstructive Sleep Apnea (OSA)
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, the investigators are conducting a prospective, self-controlled, first-night order cross-over and evaluator-blind pivotal study to evaluate the efficacy and safety of iNAP® Sleep Therapy System (iNAP®), a tongue and soft palate retaining intraoral device, in adults with OSA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients able to read and sign on the informed consent form and able to comply with study requirements.
- •Body mass index (BMI) <33 kg/m2
- •AHI between 15~55
- •Pass a device feasibility test
排除标准
- •Obstructed nasal passages
- •Hypoxemia (SpO2 <80%)
- •Primary insomnia or other suspected sleep disorder other than OSA
- •Muscle diseases, e.g. CSA
- •Patients with potential complications of sleep apnea that, in the opinion of the Investigator, may affect the study interpretation or the health or safety of the patients
研究组 & 干预措施
Treated
iNAP® Sleep Therapy System Treatment Intervention
干预措施: iNAP® Sleep Therapy System (Device)
Baseline/Control
Self-controlled, pre-treatment baseline condition
结局指标
主要结局
iNAP®-treated response rate over the apnea-hypopnea index (AHI)*
时间窗: first treatment night
\*AHI is the number of apnea/hypopnea events divided by total sleep time (TST), i.e., the number of hours of sleep. The reduction rate of AHI is calculated by dividing the AHI reduction on the Tx PSG Study when compared to the Baseline PSG Study with individual baseline AHI. An AHI reduction rate of 50% is considered responsive, namely, responder. Therefore, an overall ratio of responder to the primary endpoint cohort is the response rate.
次要结局
- Negative pressure maintenance time (hr)(first treatment night)
- Change of Oxygen Desaturation Index (ODI)** from the Baseline PSG Study compared to the Tx PSG Study(first treatment night)
- Clinical Global Impression of Change (CGI-C)(first treatment night)