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临床试验/ACTRN12616001297415
ACTRN12616001297415招募中1 期

A randomized controlled trial assessing the combined effect of acetazolamide and oxygen therapy as a novel treatment for obstructive sleep apnoea.

Monash University0 个研究点目标入组 26 人开始时间: 2016年9月15日最近更新:
适应症

试验速览

阶段
1 期
状态
招募中
入组人数
26

研究概览

简要总结

暂无简介。

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 65 Years(—)
性别
All

入选标准

  • Patients must have a confirmed diagnosis of obstructive sleep apnoea (OSA), with an apnoea hypopnoea index (AHI) greater than 15 event per hour. OSA must be diagnosed with a Level 1 or level 2 sleep study, which must have been conducted within 6 months of recruitment into the study. Participants may have trialled CPAP or another treatment for OSA, but will have to have been off treatment for at least 1 week prior to the first PSG assessment.

排除标准

  • Participants will be excluded if they have other significant diagnosed health concerns, (other than treated hypertension), such as heart, pulmonary, renal or liver disorders.
  • Patients will also be excluded if they have other sleep disorders that could affect ventilation during sleep such as central sleep apnoea (CSA, defined by a central apnoea index of greater than 10 events per hour AND/OR greater than 50% of all respiratory events classified as central), and Chronic obstructive pulmonary disease (COPD).
  • Participants will be excluded if there is evidence of renal impairment (with an estimated eGFR < 60ml/min), or evidence of an electrolyte imbalance particularly Hyponatraemia (sodium level of less than 135 mEq/L) or Hypokalaemia (serum potassium level of less than 3.5 mEq/L).
  • Participants will also be excluded if they are taking medication that could affect ventilation (eg. morphine derivatives, benzodiazepines, theophylline etc.) or muscle control (eg. certain sedatives).
  • Because participants will be untreated for OSA for a period of time (albeit only briefly), we will exclude participants with profound sleepiness (Epworth greater than or equal to 16/24) or with a history of a motor vehicle accident or near miss accident related to sleepiness in the prior 2 years.

研究者

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