NCT05881512已完成不适用
Early Feasibility Study of Transcutaneous Upper Airway Stimulation in Obstructive Sleep Apnea
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Somnial Inc
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Apnea Hypopnea Index
研究概览
简要总结
Early feasibility study to estimate the functionality of a novel intervention based on non-invasive transcutaneous electrical stimulation of the hypoglossal nerve to reduce the Apnea Hypopnea Index (AHI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male or female, aged 18 years or older
- •In good general health, as evidenced by medical history and diagnosed with moderate or severe OSA
- •In-lab PSG, within the last 6 months, with an AHI of 15-50/hour. In addition, <25% of the respiratory events on the diagnostic PSG can be attributed to central apneas
- •BMI less than or equal to 32
排除标准
- •No or mild OSA (AHI <15/h) or very severe OSA (AHI >50/hour), exclusively postural sleep apnea, or isolated Rapid-Eye-Movement (REM) sleep associated OSA.
- •Patients who are cachectic (BMI <18.5 kg/m2) or obese (BMI >32 kg/m2).
- •Patients should not have enlarged tonsils (size 3-4) and/or adenoids, nasal polyps, neuromuscular disease, hypoglossal nerve palsy, abnormal pulmonary function tests, severe pulmonary hypertension, valvular heart disease, heart failure (New York Heart Association, NYHA III-IV), recent myocardial infarction, significant cardiac arrhythmias, atrial fibrillation, stroke, opioid usage, uncontrolled hypertension, known allergic reaction to adhesives or latex, active psychiatric disease, co-existing non-respiratory sleep disorder, pregnancy or significant metal implants or cardiac/other pacemakers.
- •Patients with facial hair that affects the correct placement of the electrodes, if they are unwilling to shave.
结局指标
主要结局
Apnea Hypopnea Index
时间窗: Overnight (day 1)
Episodes of apnea and/or hypopnea scored during the course of sleep study
次要结局
- Arterial Oxygen Saturation (SaO2)(Overnight (day 1))
研究者
研究点 (2)
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