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

Phase 1

Recruiting

• Conditions: Obstructive Sleep Apnoea; Respiratory - Sleep apnoea

• Registration Number: ACTRN12616001297415
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-15
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
oop gain as measured from clinical polysomnography (PSG)[ Days 4, 5, 6 or 7 after daily administration of acetazolamide/placebo]