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.
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.
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