Effect of Atomoxetine and Oxybutynin on Phenotype Traits and OSA Severity
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 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. Until recently, the search for medicines to activate pharyngeal muscles in sleeping humans has been discouraging. However, exciting new animal research has shown that drugs with noradrenergic and antimuscarinic effects can restore pharyngeal muscle activity to waking levels. In this protocol the investigators will test the effect of atomoxetine (a norepinephrine reuptake inhibitor) and oxybutynin (an antimuscarinic drug) administered together 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
- 未提供
排除标准
- •Any medical condition other than well controlled hypertension.
- •Any medication known to influence breathing, sleep/arousal or muscle physiology.
- •Claustrophobia.
- •Inability to sleep supine.
- •Allergy to lidocaine, Oxymetazoline HCl, atomoxetine/oxybutynin.
- •Individuals with underlying cardiac disease, such as arrhythmias.
- •Individuals taking psychiatric medications, such as atomoxetine, 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 2 hours before bedtime
干预措施: Placebo, 2 tablets (Drug)
Combination product of Atomoxetine and Oxybutynin
Combination product of Atomoxetine 80 mg and Oxybutynin 5 mg 2 hours before sleep
干预措施: Combination product of Atomoxetine and Oxybutynin (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 Atomoxetine and Oxybutynin will reduce AHI more effectively in subjects with moderate sleep apnea, mildly obese (BMI\<32), Vpassive \> 50% of Veupnea (ventilation during eupneic ventilatory drive), low muscle compensation (Vactive - Vpassive \<1 L/min)
次要结局
- Genioglossus Muscle Responsiveness to Increased Ventilatory Drive (Esophageal Pressure Swings)(1 night)
研究者
David Andrew Wellman
Assistant Professor of Medicine - Harvard Medical School
Brigham and Women's Hospital