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:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 115
- 试验地点
- 36
- 主要终点
- Change in Apnea Hypopnea Index (AHI4%)
研究概览
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
- •Palatine tonsil size 3+ or 4+ by the Brodsky Classification
- •Fixed upper airway obstructions (tumor, polyps, nasal obstruction)
- •Congenital malformations in the airway
- •Hypoglossal nerve palsy (bilateral limited tongue movement, or unilateral unintended tongue deviation during protrusion)
- •Existing swallowing difficulty as measured by a score of ≥3 on the EAT-10 questionnaire
- •Others deemed sufficient to impair the ability of the Genio® System to treat OSA in the judgment of the investigator
- •Significant comorbidities that contraindicate surgery or general anesthesia:
- •Revised Cardiac Risk Index Class III or IV
- •Persistent uncontrolled hypertension (defined as systolic pressure 160 mm Hg or a diastolic pressure of 120 mm Hg) despite medications
- •Coagulopathy or required anticoagulant medications (such as warfarin, clopidogrel (Plavix) or similar; prophylactic aspirin not exclusionary) that cannot be safely stopped in the perioperative period
- •Degenerative neurological disorder (i.e., Parkinson's disease, Alzheimer's disease)
- •Acute illness or infection
- •Diagnosed psychiatric disease (e.g., psychotic illness, uncontrolled major depression or acute anxiety attacks) that prevents participant compliance with the requirements of the investigational study testing
- •Substance or alcohol abuse history within the previous 3 years. Alcohol and substance abuse are defined as follows:
- •i. Alcohol: no days with less than 3 or 4 standard drinks for women and men, respectively
- •ii. Substance: the use of any substance in an amount unapproved by the investigator or considered illegal. The drugs most commonly abused include cocaine, marijuana, heroin (or substitution treatment), prescription drugs (especially painkillers), methamphetamines, and various other illegal substances.
- •h) Life expectancy less than the primary endpoint study period (12 months post-surgery)
- •i) Any other chronic medical illness or condition that contraindicates a surgical procedure or general anesthesia in the judgment of the investigator.
- •Prior surgery or treatments that could compromise the effectiveness of the Genio System:
- •Airway cancer surgery or radiation
- •Mandible or maxilla surgery in the previous 5 years (not counting dental treatments)
- •Other upper airway surgery to remove obstructions related to OSA in the previous 3 months (e.g., uvulopalatopharyngoplasty (UPPP), tonsillectomy, nasal airway surgery)
- •Prior hypoglossal nerve stimulation device implantation
- •Has an Active Implantable Medical Device (AIMD) even if the device can be temporarily turned off.
- •Participation in another clinical study with an active treatment arm that could confound the results of the DREAM study.
- •Plan to become pregnant, currently pregnant, or breastfeeding during the study period.
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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