ACTRN12618001499279已完成1 期
The effects of AD098, AD153 and AD639 on obstructive sleep apnoea (OSA) severity in men and women with moderate-to-severe OSA
Apnimed0 个研究点目标入组 11 人开始时间: 2018年9月6日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 11
研究概览
简要总结
There was no significant effect of either drug combinations on reducing OSA severity or improving any of the key physiological causes of OSA. However, duloxetine+oxybutynin did significantly increase the fraction of hypopnoeas to apnoeas compared to placebo (p = 0.02; d = 0.54). In addition, duloxetine+oxybutynin reduced time in REM sleep (p = 0.009; d = 1.03) which was positively associated with a reduction in OSA severity (R2 = 0.62; p = 0.02). In summary - neither drug combination significantly improved OSA severity or modified the key OSA physiological causes of OSA when administered as a single dose to unselected OSA. patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 70 Years(—)
- 性别
- All
入选标准
- •Otherwise healthy men and women with moderate-to-severe obstructive sleep apnoea
排除标准
- •Any chronic medical condition other than controlled hypertension, hyperlipidemia, diabetes.
- •Any medication known to influence breathing, sleep/arousal or muscle physiology.
- •Claustrophobia.
- •Inability to sleep supine.
- •Central apnea index >5 events/h
- •Tonsillar hypertrophy or craniofacial malformation
- •Allergy to lidocaine, oxymetazoline HCl or study medications
- •For women: Pregnancy or breast feeding.
研究者
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