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临床试验/ACTRN12618001499279
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

发起方
Apnimed

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