A Double-Blind Randomized Physiological Study Examining the Effects of Eszopiclone on the Arousal Threshold and Obstructive Sleep Apnea Severity
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Apnea Hypopnea Index
研究概览
简要总结
The purpose of this study is to find out whether taking eszopiclone (Lunesta) changes the breathing effort required to briefly wake people with obstructive sleep apnea from sleep (respiratory arousal threshold). We would like to see if taking eszopiclone can reduce the severity of obstructive sleep apnea in some people (those that have a low respiratory arousal threshold; i.e. wake up easily to respiratory stimuli).
详细描述
Obstructive sleep apnea is an exceedingly common disease with major neurocognitive and cardiovascular consequences. The current primary treatment e.g. Continuous positive airway pressure (CPAP) is effective but poorly tolerated by many patients particularly those with mild-moderate disease. Secondary treatments such as oral appliances to advance the mandible or surgical procedures to enlarge the airway are commonly appealing to the patient. However, these approaches have only modest success in reducing apnea frequency to an acceptable level. Thus, finding tolerable and effective therapy for sleep apnea remains an important objective.
The causes of sleep apnea vary between patients. Targeted therapy according to the underlying causes of sleep apnea in individual patients is likely to be most effective. However, current therapeutic options for sleep apnea are quite limited. The purpose of this physiological research study is to determine if taking eszopiclone (Lunesta)changes the breathing effort required to briefly wake people with obstructive sleep apnea from sleep (the arousal threshold) and if administration of the sedative medication eszopiclone (Lunesta) to certain sleep apnea patients (those with a low arousal threshold ie wake up easily) would be beneficial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-64 years old
- •Untreated obstructive sleep apnea
排除标准
- •Nadir SaO2 <70% on a baseline PSG
- •Medications known to affect either sleep, breathing or muscle activity
- •Major co-morbidities apart from sleep apnea
- •Allergy to lidocaine, oxymetazoline HCl, or eszopiclone
- •Women who are pregnant
研究组 & 干预措施
Eszopiclone
Eszopiclone 3mg prior to sleep (1 night)
干预措施: Eszopiclone (Drug)
Sugar Pill
Sugar Pill (placebo) prior to sleep (1 night)
干预措施: Placebo (Drug)
结局指标
主要结局
Apnea Hypopnea Index
时间窗: 8 hour In-Laboratory Polysomnogram (PSG)
number of respiratory events per hour of sleep Respiratory events last for at least 10 seconds and are associated with a decrease in blood oxygenation or a cortical arosual from sleep. AHI values are typically categorized as 5-15/hr = mild; 15-30/hr = moderate; and \> 30/h = severe
次要结局
- Arousal Threshold(8 hour In-Laboratory Polysomnogram (PSG))
- Nadir Overnight Oxygen Saturation(8 hour In-Laboratory Polysomnogram (PSG))
- Sleep Duration(8 hour In-Laboratory Polysomnogram (PSG))
研究者
Atul Malhotra, MD
Associate Professor
Brigham and Women's Hospital
