Feasibility of Non-invasive Electrical Nerve Stimulation of the Upper Airway in Patients With Obstructive Sleep Apnoea
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Tolerability of non-invasive electrical stimulation of the upper airway during sleep
研究概览
简要总结
Project Breathe 1 is a short-duration (5 month) pilot investigation to assess the safety and tolerability of non-invasive electrical stimulation in adults with obstructive sleep apnoea. The investigation is an unblinded, uncontrolled, single arm design.
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
盲法说明
Assessors scoring the drug induced sleep endoscopy VOTE videos will be blinded to the treatment provided.
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Obstructive sleep apnoea diagnosis with an AHI of 15-50 events/hour recorded in the baseline polysomnography (PSG)
- •BMI < 32 kg/m²
- •Age > 18 years old
- •Able to read, write, and speak Dutch with acceptable visual and auditory acuity
- •Able and willing to provide informed consent
排除标准
- •Presence of a cardiac pacemaker or implantable cardiac defibrillator or ventriculoperitoneal shunt
- •Central (non-obstructive) AHI episodes >5 events/hour recorded in the baseline PSG
- •Inability to sleep supine
- •Pregnancy
- •Inability to undergo DISE
- •Inability or unwillingness to shave under and around their chin and neck if appropriate
- •Known inability to complete PSG with a total sleep time of > 4 hours
- •The use of other neurostimulatory devices
- •A diagnosis of periodic leg movement disorder
- •Awake resting arterial oxygen saturation <93% (suggesting possible hypoventilation)
- •Unstable, untreated coronary or peripheral artery disease
- •Severe arterial hypertension defined as a resting blood pressure (BP) of >180/110mmHg
- •Currently employed as a professional driver
- •Any previous sleep-related driving accident
- •A past or current condition that in the opinion of the investigator contraindicates enrolment (e.g. chronic substance abuse, severe psychiatric disorders)
研究组 & 干预措施
Non-invasive electrical stimulation of the upper airway
Participants will have bilateral non-invasive electrical stimulation of the submandibular region while undergoing a polysomnography assessment and during drug induced sleep endoscopy.
干预措施: Non-invasive electrical stimulation (Device)
结局指标
主要结局
Tolerability of non-invasive electrical stimulation of the upper airway during sleep
时间窗: Night 1
The proportion of participants who are able to tolerate 80% of their maximum awake tolerated dose during sleep.
次要结局
- Arousals(Night 1)
- Subjective awareness of stimulation during sleep(Night 1)