Multicenter Proof-of-Concept Study to Investigate the Feasibility and Respiratory Effects of Stimulating Two Functional Targets (Neural and/or Muscular) for the Treatment of Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 8
- 主要终点
- Feasibility of technical delivery in stimulating target nerves or muscles
研究概览
简要总结
This proof-of-concept study is to collect acute and short-term sub-acute (if applicable) changes in respiratory parameters following the percutaneous placement of electrode arrays. Acute placement and data collection will be conducted while performing a Drug Induced Sleep Endoscopy (DISE) where the goal will be to quantify changes in airflow with stimulation. Data will also be collected during a one- or two-night polysomnography (PSG) to investigate airflow and sleep stability responses with and without different levels of stimulation during sleep. Where feasible, OSA severity data will be collected, as measured via the apnea/hypopnea index (AHI) with stimulation versus without stimulation as a secondary objective. Both data collections will be done when stimulating the hypoglossal nerve (HGN) or Genioglossus muscle (GG) and a second functional target (Ansa Cervicalis - AC) or the strap muscles (sternohyoid and sternothyroid) with a set of electrode arrays either in combination or separately.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •A subject must meet all of the following inclusion criteria to be eligible for inclusion in this study:
- •Age above 18 years not under guardianship, under curatorship or under judicial protection.
- •Body Mass Index (BMI) < 35 kg/m
- •OSA (15 < AHI < 80 events/h sleep) documented by a sleep study performed during the past 24 months in the absence of any major weight change or other medical issues.
- •Subject must be eligible for a diagnostic DISE or surgical procedure (acute study measures only).
- •Written informed consent obtained from the subject prior to performing any study specific procedure.
- •Willing and capable to comply with all study requirements, including specific lifestyle considerations, evaluation procedures and questionnaires for the whole duration of the trial.
排除标准
- •Subjects meeting any of the following criteria will be excluded from participation in this study:
- •Major anatomical or functional abnormalities that would impair the ability of the electrode arrays to be positioned.
- •Significant comorbidities that contraindicate surgery or general anesthesia/DISE
- •Significant tongue weakness
- •Any other chronic medical illness or condition that contraindicates a surgical procedure or general anesthesia/DISE in the judgment of the investigator.
- •Prior surgery or treatments that could compromise the placement and effectiveness of the electrode array systems:
- •Airway cancer surgery or radiation,
- •Mandible or maxilla surgery in the previous 3 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.
- •Currently pregnant, or breastfeeding during the study period
研究组 & 干预措施
Target stimulation
Stimulation of the Hypoglossal nerve (HGN) or Genioglossus muscle (GG) and a second functional target (Ansa Cervicalis - AC) or the strap muscles (sternohyoid and sternothyroid).
干预措施: Target stimulation (HGN, AC, GG, Strap muscles) (Device)
结局指标
主要结局
Feasibility of technical delivery in stimulating target nerves or muscles
时间窗: Day 0 to 3
Assessment of the technical ability to simulate the target nerves and/or muscles as observed during nasoendoscopy and ultrasound imaging
Assessment of the required stimulation amplitude
时间窗: Day 0 to 3
Assess the required stimulation amplitude measured in milliamps (mA) to improve airflow during stimulation as assessed by direct visualisation of the amplitude.
Feasibility of participant recruitment and retention
时间窗: Day 0 to 30
Demonstration of participant recruitment and retention rates for a POC target stimulation in OSA participant study, measured by direct participant recruitment numbers and during on study.
次要结局
- Acute increase in airflow measured during target stimulation(Day 0 to 3)
- Assessment of acute airway opening during target stimulation(Day 0 to 3)
- Assessment of sub-acute airflow increase and/or AHI reduction during target stimulation during a sleep study.(Day 0 to 3)