Single Center Proof-of-Concept Study to Determine the Flow Changes And/or AHI Reduction When Stimulating Two Targets (neural And/or Muscular) for the Treatment of Obstructive Sleep Apnea in Adult Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Impacts on acute airway opening
研究概览
简要总结
This Proof-of-Concept study will collect acute and sub-acute flow and/or AHI data following the placement of lead arrays under direct vision. The acute placement and data collection will be collected following the completion of the pre-scheduled neck dissection surgery. The sub-acute data will be collected in a sleep lab during a polysomnography (PSG). Both data collections will be done when stimulating (using an external pulse generator) the hypoglossal nerve or Genioglossus muscle (GG) and a second neural target (Ansa Cervicalis - AC) or the strap muscles (sternohyoid and sternothyroid) with a set of Off-the-Shelf (OTS) electrode arrays.
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 patient 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) < 38 kg/m
- •Subject must be eligible for neck dissection surgery.
- •Written informed consent obtained from the patient 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
- •Patients 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.
- •Significant tongue weakness.
- •Aerodigestive tract tumor or reconstructive surgery performed at the same time as neck dissection.
- •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 placement and effectiveness of the electrode array systems:
- •Airway cancer surgery or radiation, or
- •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.
- •Concomitant oral or pharyngeal surgery.
研究组 & 干预措施
Target stimulation
Stimulation of a combination of targets: Hypoglossal nerve (HGN) and Ansa Cervicalis (AC), Genioglossus (GG) and AC, HGN and strap muscles, or GG and strap muscles, during an acute and sub-acute phase.
干预措施: Target Stimulation (HGN, AC, GG, Strap muscles) (Device)
结局指标
主要结局
Impacts on acute airway opening
时间窗: Day 0 to 3
Demonstration of acute airway opening as visually observed under nasoendoscopy when stimulating the HGN or GG and a second target (neural or direct muscle stimulation).
Impacts on airflow during a acute assessment
时间窗: Day 0 to 3
Acute increase in airflow when stimulating the HGN or GG and a second target (neural or direct muscle stimulation), measured by changes in amplitude (mA) during target stimulation.
次要结局
- Impacts on airway opening during a sub-acute assessment(Day 0 to 3)