NCT03868618
进行中（未招募）
不适用
A Multicenter Study to Assess the Safety and Effectiveness of the Genio Dual-sided Hypoglossal Nerve Stimulation System for the Treatment of Obstructive Sleep Apnea in Adults Subjects
Nyxoah S.A.36 个研究点 分布在 4 个国家目标入组 115 人开始时间: 2020年10月14日最近更新:
概览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Nyxoah S.A.
- 入组人数
- 115
- 试验地点
- 36
- 主要终点
- Change in Apnea Hypopnea Index (AHI4%)
概览
简要总结
A multicenter study to assess the safety and effectiveness of the Genio dual-sided hypoglossal nerve stimulation system for the treatment of obstructive sleep apnea in adults subjects.
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
- 22 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 22 to 75 years (inclusive). Participant cannot be under guardianship, under curatorship or under judicial protection.
- •Body mass index (BMI) ≤ 32 kg/m
- •Cricomental space positive (≥ 0 cm). The cricomental space is the distance between the neck and the bisection of a line from the chin to the cricoid membrane when the head is in a neutral position.
- •Has either not tolerated, has failed or refused positive airway pressure (PAP) treatment
- •Moderate to severe OSA (15≤AHI4≤65 where combined central and mixed AHI \< 25% of the total AHI) based on a screening PSG.
- •Non-supine AHI \> 10 events on the screening PSG or participant has either not tolerated, has failed or refused positional therapy.
- •Written informed consent obtained from the participant prior to performing any study specific procedure.
- •Willing and capable to comply with all study requirements, including specific lifestyle considerations, performing all follow-up visits and sleep studies, evaluation procedures and questionnaires for the whole duration of the trial.
- •Willing to consent to long term follow-up of 5 years post-surgery.
排除标准
- •Inadequately treated sleep disorders other than OSA that would confound functional sleep assessment:
- •Severe chronic insomnia
- •Insufficient sleep syndrome (\<6 hours sleep per night)
- •Restless legs syndrome
- •REM behavior disorder
- •Others deemed sufficient disorders that would confound functional sleep assessment in the judgment of the investigator
- •Night shift worker defined as individual working between the hours of 10:00 pm and 7:00 am at least 3 nights per working week.
- •Taking medications 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:
- •Craniofacial abnormalities narrowing the airway or the implantation site
研究组 & 干预措施
Genio Therapy
Experimental
The Genio™ system is an implantable neurostimulation system comprised of one implanted device
干预措施: Genio™ system (Device)
结局指标
主要结局
Change in Apnea Hypopnea Index (AHI4%)
时间窗: 12 months
percentage of responders at 12 months based on AHI4
Change in Oxyhemoglobin Desaturation Index (ODI4%)
时间窗: 12 months
percentage of responders at 12 months based on ODI4
次要结局
- FOSQ-10(12 months)
- SNORE-25(12 months)
- ESS(12 months)
- ODI4(12 months)
- SaO2 < 90%(12 months)
- AHI4(12 months)
研究者
研究点 (36)
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