Inspire Singapore Study: Confirmation of Therapy Performance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 4
- 主要终点
- Inspiratory Overlap
研究概览
简要总结
Prospective, multicenter, open-label study designed to confirm device performance of Inspire system in Singapore.
详细描述
Patients who meet study eligibility criteria will be implanted with an Inspire system and followed for 6 months post-therapy-activation. Study subjects will undergo in-lab sleep studies to confirm inspiratory overlap (1st PSG, after therapy activation), titrate the therapy (2nd PSG, at 3 months post-activation) and confirm therapy performance (3rd PSG, at 6 months post-activation). Symptoms and quality of life (assessed by ESS and FOSQ), therapy adherence, and adverse events will also be collected and reported.
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
- •Main Inclusion Criteria:
- •Diagnosis of moderate to severe OSA (AHI 15-65)
- •Failure of, or intolerance to CPAP
排除标准
- •Central + mixed apneas > 25% of total AHI
- •Presence of complete concentric collapse (CCC)
- •Compromised neurological control of the upper airway.
- •Other eligibility criteria may apply.
研究组 & 干预措施
Hypoglossal nerve stimulation
干预措施: Inspire System (Device)
结局指标
主要结局
Inspiratory Overlap
时间窗: 0-3 months post-therapy activation
Percentage (%) of inspiratory overlap as measured by polysomnography (PSG)
次要结局
- Therapy Effectiveness(6 months post-therapy activation)
- Symptom Reduction(6 months post-therapy activation)