Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Neurostimulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- LivaNova
- 入组人数
- 107
- 试验地点
- 30
- 主要终点
- Rate of all serious adverse device/procedure related events from time of implant through month 7
研究概览
简要总结
Multi-center, open-label, prospective, randomized clinical trial of the aura6000(R) System for the reduction of apnea and hypopneas in adult patients with moderate to severe obstructive sleep apnea who have failed or are unwilling to use positive airway pressure treatment.
详细描述
All qualifying subjects will be implanted. Subjects will be randomized 2:1 in favor of Stimulation therapy (Active Group). Randomization will occur following implant and prior to the Month 1 visit.
The Active group will start Stimulation therapy at Month 1. The Control group may continue with their current sleep apnea treatment until Month 7, and will receive Stimulation therapy beginning at Month 7 +1Day. (All subjects are excluded from use of PAP or surgical treatments after enrollment through Month 13)
Safety and efficacy will be evaluated at Month 7, and again at Month 13.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
PSG results are masked from the Investigator and Outcomes Assessor.
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Abbreviated: Additional criteria may apply:
- •Inclusion Criteria:
- •Diagnosis of moderate to severe OSA
- •Declines to use or does not tolerate PAP therapy
排除标准
- •Respiratory, cardiac, renal disease or other co-morbid conditions
- •BMI > 35 kg/m2
- •Specific PSG criteria outlined in the protocol
研究组 & 干预措施
Active
HGN therapy activation at Month 1 - compared at Month 7 to Control group, continued stimulation through Month 13
干预措施: Hypoglossal Nerve Stimulation (Device)
Control
HGN therapy NOT activated at Month 1 - compared at Month 7 to Active group, stimulation will start at Month 7 + 1 Day and continue through Month 13
干预措施: Hypoglossal Nerve Stimulation (Device)
结局指标
主要结局
Rate of all serious adverse device/procedure related events from time of implant through month 7
时间窗: Month 1 through Month 7
The primary safety endpoint is a descriptive evaluation of all reported serious adverse device/procedure related events (SADEs) through M7 for both groups. Relationship to procedure, device and study will be adjudicated by a Clinical Events Committee (CEC).
Rate of response to therapy when compared to no therapy for 6 months
时间窗: Month 1 through Month 7
The primary efficacy endpoint is to demonstrate that the AHI responder rate of subjects with the device stimulation activated (Active Group) is statistically significantly higher than the AHI responder rate of subjects with the device stimulation not activated (Control Group) at M7.
次要结局
- Change in EQ-5D (Efficacy)(Baseline through Month 7)
- Change in PROMIS SDI/SRI (Efficacy)(Baseline through Month 7)
- Decrease in Oxygen Desaturation Index (Efficacy)(Baseline through Month 7)
- Change in Functional Outcomes of Sleep Questionnaire (Efficacy(Baseline through Month 7)
- Change in Epworth Sleepiness Scale (Efficacy)(Baseline through Month 7)
- Change in SF-36 (Efficacy)(Baseline through Month 7)
- Change in CGI-S/CGI-I (Efficacy)(Baseline through Month 7)
- Descriptive analysis of all reported Adverse Events (Safety)(Consent through Month 7)