Single Center Proof-of-Concept Study to Determine the Flow Changes When Stimulating Two Neural Targets for the Treatment of Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Assessment of changes in airflow outcomes
研究概览
简要总结
This proof-of-concept study will evaluate the impact of surgically placing and stimulating the hypoglossal nerve and/or a second neural target Ansa Cervicalis, with a set of off-the-shelf 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
- •Age above 18 years not under guardianship, under curatorship or under judicial protection.
- •Body Mass Index (BMI) < 35 kg/m
- •Subject suffers from OSA (15 < AHI < 80) documented by a sleep study performed during the past 36 months.
- •Subject must be eligible for a diagnostic or surgical procedure.
- •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
- •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
- •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,
- •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
结局指标
主要结局
Assessment of changes in airflow outcomes
时间窗: Day 0
Assessment of acute changes in airflow when stimulating the HGN in combination with the AC during a flow limited event (hypopnea or apnea).
Incidence of participants with changes in cross-sectional area airway opening during target stimulation
时间窗: Day 0
Assessment of patients with changes in acute cross-sectional area airway opening measured in cm2 under nasoendoscopy when stimulating two neural targets (the HGN and AC). Video imaging and physician interpretation of nasoendoscopic images will be used to review outcome measures.
次要结局
- Number of participant adverse events observed during the study(Day 30)