A Post-market Clinical Follow up of the Genio® System for the Treatment of Obstructive Sleep Apnea in Adults.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 110
- 试验地点
- 19
- 主要终点
- Incidence of device-related Serious Adverse Events (SADEs)
研究概览
简要总结
The primary objective of this study is to confirm the safety and clinical effectiveness of the Genio® system in moderate to severe Obstructive Sleep Apnea (OSA) adult patients over a period of 5 years post-surgery.
详细描述
This study is a multicenter, prospective single arm PMCF. Following activation of the Genio® system between 6 to 10 weeks post-surgery, patients will be followed at 3 months, 6 months, 9 months, 12 months and then every year for a total period of 5 years after surgery. Phone calls follow-up will be performed at Month 18, Month 30, Month 42 and Month 54.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body Mass Index (BMI) < 35 kg/m2
- •AHI between 15 to 65 events/hour documented by the closest PSG performed at the time of the patient ICF signature and within maximum 12 months of screening and fulfilling the required technical criteria or during the screening phase.
- •Has either not tolerated, has failed or refused Positive Airway Pressure (PAP) or Mandibular Advancement Device (MAD) treatments.
排除标准
- •Inadequately treated sleep disorders other than OSA that would confound functional sleep assessment;
- •Taking medication that in the opinion of the Investigator may alter consciousness, the pattern of respiration, or sleep architecture;
- •Major anatomical or functional abnormalities that would impair the ability of the Genio® system to treat OSA;
- •Inadequately treated psychiatric disease that prevent patient compliance with the requirements of the investigational study testing;
- •Life expectancy < 12 months;
- •Participation in another clinical study (excluding registries) during the study period (3 years).
研究组 & 干预措施
Genio® system therapy
Following activation of the Genio® system at 8 weeks post-surgery, patients will be followed at 12 weeks, 6 months, 9 months, 12 months and then every year for a total period of 5 years after surgery.
干预措施: Genio® system therapy (Device)
结局指标
主要结局
Incidence of device-related Serious Adverse Events (SADEs)
时间窗: 12 months post-surgery
Incidence of device-related Serious Adverse Events (SADEs)
Change in Apnea-Hypopnea Index from baseline
时间窗: 12 months post-surgery
Change in Apnea-Hypopnea Index (AHI) from baseline as measured by sleep lab
Change in the quality of life measured by the Functional Outcomes of Sleep Questionnaire
时间窗: 12 months post-surgery
Change in the quality of life measured by the Functional Outcomes of Sleep Questionnaire (FOSQ)
次要结局
未报告次要终点