Optimal Dosage of Acetazolamide for OSA Treatment

Last updated: May 17, 2021
Sponsor: University Hospital, Antwerp
Overall Status: Active - Recruiting

Phase

4

Condition

Sleep Apnea Syndromes

Treatment

N/A

Clinical Study ID

NCT04726982
B3002021000015
  • Ages 18-79
  • All Genders

Study Summary

Acetazolamide, a carbonic anhydrase inhibitor, has received some attention as potential treatment for obstructive sleep apnea (OSA). It produces a metabolic acidosis by excreting bicarbonate, thereby stimulating baseline ventilation. Evidence suggests that acetazolamide primarily improves ventilatory control instability (expressed as loop gain), which is an important contributor to the pathophysiology of OSA.

Few studies have assessed the efficacy of acetazolamide in patients with OSA. Since most of them had a small sample size and used different therapeutic dosages, clinical applications are currently limited. Therefore, this study aims to compare the effect of two acetazolamide dosages on the severity and pathophysiology of OSA.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • AHI between 15 and 65 events/hour
  • BMI < 35 kg/m²

Exclusion

Exclusion Criteria:

  • Craniofacial anomalies
  • Central sleep apnea (defined as central AHI > 25% of total AHI)
  • Contra-indications related to acetazolamide treatment
  • Hypersensitivity to sulphonamides or acetazolamide
  • Renal impairment, electrolyte imbalances, and/or adrenocortical insufficiency
  • Clinically significant metabolic, hepatic, and/or hematological disease
  • Chronic obstructive pulmonary disease
  • Closed-angle glaucoma
  • Conditions likely to affect OSA physiology: neuromuscular disease or other majorneurological disorders, heart failure, or any other unstable major medical condition.
  • Intake of drugs that substantially stimulate or depress respiration, includingbenzodiazepines, opioids, theophylline, and pseudoephedrine
  • Inadequately treated sleep disorders other than OSA that would confound functionalsleep assessment
  • Inability of the patient to understand and/or comply to the study procedures
  • Active psychiatric disease (psychotic illness, major depression, anxiety attacks,alcohol or drug abuse)
  • Pregnancy

Study Design

Total Participants: 100
Study Start date:
April 20, 2021
Estimated Completion Date:
December 31, 2022

Study Description

In this double-blind, parallel-group, controlled trial, eligible patients will be randomized into one of the following treatment arms: (1) placebo, (2) 250 mg of acetazolamide, or (3) 500 mg of acetazolamide. After 4 weeks, treatment outcome will be assessed by in-laboratory polysomnography. Additionally, arterial blood gas analysis and lung function tests will be performed before and during treatment.

Connect with a study center

  • Antwerp University Hospital

    Edegem, Antwerp 2650
    Belgium

    Active - Recruiting

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