Effect of DAW1033D on Obstructive Sleep Apnea and Its Phenotypic Traits
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Apnea Hypopnea Index (AHI, Events/Hour of Sleep)
研究概览
简要总结
Obstructive sleep apnea (OSA) is common and has major health implications but treatment options are limited. OSA patients show a marked reduction in upper airway (UA) dilator muscle activity at sleep onset and this phenomenon leads to increased collapsibility of UA compared to normal subjects. In this protocol the investigators will test the effect of DAW1033D administered before sleep on OSA phenotype traits and OSA severity during sleep.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AHI > 15
排除标准
- •Any medical condition other than well controlled hypertension, diabetes, hyperlipidemia
- •Any medication known to influence breathing, sleep/arousal or muscle physiology.
- •Claustrophobia.
- •Inability to sleep supine.
- •Allergy to lidocaine, Oxymetazoline HCl, DAW1033D.
- •Individuals with underlying cardiac disease, such as arrhythmias.
- •Individuals taking psychiatric medications, or any of the studied medications for medical care.
- •History of seizures
- •For women: Pregnancy.
- •History of panic disorder / hyperventilation syndrome / Attention deficit-hyperactivity disorder (ADHD) / autism
研究组 & 干预措施
Placebo
Placebo capsule 30 minutes before sleep
干预措施: Placebo oral capsule (Drug)
DAW1033D
DAW1033D capsule 30 minutes before sleep
干预措施: DAW1033D oral capsule (Drug)
结局指标
主要结局
Apnea Hypopnea Index (AHI, Events/Hour of Sleep)
时间窗: 1 night
Based on previous studies the investigators anticipate that DAW1033D will reduce AHI more effectively in subjects with moderate sleep apnea, and mild to moderate pharyngeal collapsibility. AHI describes the frequency of obstruction of the upper airway during sleep and is commonly used to describe the presence and severity of obstructive sleep apnea.
次要结局
- Collapsibility of the Upper Airway: VPassive(1 night)
研究者
David Andrew Wellman
Associate professor HMS
Brigham and Women's Hospital