A Multicentre, Prospective, Open-label, 2 Groups Study to Assess the Safety and Performance of the Genio™ Bilateral Hypoglossal Nerve Stimulation System for the Treatment of Obstructive Sleep Apnoea in Adult Patients With and Without Complete Concentric Collapse of the Soft Palate
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 42
- 试验地点
- 8
- 主要终点
- Change from baseline to 6 months post implantation in the apnoea-hypopnea index (AHI)
研究概览
简要总结
The objective of this study is to explore the safety and performance of the Genio™ system in adult obstructive sleep apnoea (OSA) patients with and without complete concentric collapse of the soft palate over a period of 4.5 months of treatment (i.e. 6 months post-surgery) measured by the AHI, at rest to determine if there is a difference in performance between the two populations.
详细描述
This is a prospective, open-label, multicentric, 2 groups study to assess the safety and performance of the Genio™ system in adult obstructive sleep apnoea (OSA) patients with and without complete concentric collapse of the soft palate. Participants will be consented, enrolled and eligibility criteria checked. If the participant is eligible, participant will proceed with the Genio™ IS implantation. Six (6) weeks after implantation, the implant will be activated and study visits will be scheduled at Week 7, Month 2, Month 3, Month 4, Month 5 and Month 6.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Man or woman between 21 and 75 years of age
- •Body mass index (BMI) ≤ 32 kg/m2
- •Obstructive apnoea-hypopnea index (AHI) of 15-50 events/hour
- •Participants who have either not tolerated, have failed or refused positive airway pressure (PAP) treatments.
排除标准
- •Unable or incapable of providing informed written consent
- •Unwilling or incapable of returning to all follow-up visits and sleep studies, including evaluation procedures and filling out questionnaires
结局指标
主要结局
Change from baseline to 6 months post implantation in the apnoea-hypopnea index (AHI)
时间窗: Change from baseline to 6 months post implantation in the apnoea-hypopnea index (AHI)
Incidence of serious device-related adverse events recorded during the study
时间窗: 6 months
次要结局
- Change from baseline to 12, 24 and 36 months post implantation in Apnea Hypopnea Index (AHI)(12, 24, 36 months)
- Change from baseline to 6, 12, 24 and 36 months post implantation in Oxygen Desaturation Index (ODI)(6,12, 24, 36 months)