Local Neostigmine for Treatment of Snoring During Drug-Induced Sleep Endoscopy
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Change in decibel sound after injection of neostigmine
研究概览
简要总结
The study team is seeking a novel treatment for snoring involving local application of a nerve stimulant medication, neostigmine. In this study, neostigmine will be injected into 5 sites of the soft palate during a standard procedure, drug-induced sleep endoscopy, to evaluate the effect on snoring.
详细描述
Snoring is a major problem, affecting 40 million Americans. The disease affects patient and partner sleep quality as well as daytime function. Snoring treatment is limited by device compliance (mouth appliance, positive airway pressure) and insurance does not regularly pay for these devices. Surgical treatment for snoring has mixed results. As a result, there is an important need to develop new treatments for snoring.
The study team is seeking a novel treatment for snoring involving local application of a nerve stimulant medication, neostigmine. In this study, neostigmine will be injected into 5 sites of the soft palate during a standard procedure, drug-induced sleep endoscopy, to evaluate the effect on snoring. If successful, development of a topical (non-injectable) version of this drug will be considered, so that the patient can apply him/herself before bedtime.
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
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
- •Snoring or mild obstructive sleep apnea
- •English-speaking
- •Greater than 18 years old
- •Able to give informed consent
排除标准
- •On active anti-coagulation medication
- •Pregnant women
- •Hypersensitivity to neostigmine
- •Peritonitis or mechanical obstruction of the intestinal or urinary tract
- •Coronary artery disease
- •Cardiac arrhythmia
- •Recent acute coronary syndrome
- •Myasthenia gravis
研究组 & 干预措施
Drug-induced sleep endoscopy (DISE) with Neostigmine
Artificial sleep will be induced by intravenous administration of propofol with micro boluses until clinical sleep is achieved with spontaneous respiration and observed apneas under monitored anesthesia care. Endoscopy will be performed with visualization on a monitor and recording on a digital recorder. After the patient demonstrates snoring and obstruction collapse, the patient will receive the study medication (neostigmine methylsulfate 1mg/mL) into the soft palate.
干预措施: Neostigmine Methylsulfate (Drug)
结局指标
主要结局
Change in decibel sound after injection of neostigmine
时间窗: The DISE will occur up to 30 days after the pre-op visit and study enrollment
The data will come from the drug-induced sleep endoscopy (DISE) audio and video recordings. Prior to the neostigmine injection, a snoring microphone will be placed over the right clavicle. Following administration of neostigmine, the patient will be observed for an additional 4 minutes to examine sound emanating from the soft palate. Total run time, instantaneous decibel levels, LAeq (average decibel level over time), and the maximum decibel level will be recorded.
Change in soft palate motion after injection of neostigmine
时间窗: The DISE will occur up to 30 days after the pre-op visit and study enrollment
The data will come from the drug-induced sleep endoscopy (DISE) audio and video recordings. Following administration of neostigmine, the patient will be observed for an additional 4 minutes to examine vibration emanating from the soft palate.
次要结局
未报告次要终点
研究者
Raj Dedhia
Asstant Professor
Emory University