Acetazolamide Add-On Therapy to OSA Surgery

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Surgical procedures are routinely performed as an alternative to continuous positive airway pressure treatment in patients with obstructive sleep apnea (OSA). However, the response to surgery is often variable. Instability of the respiratory control during sleep (or high loop gain) has been associated with poor surgical results in previous research. Acetazolamide (AZM), a carbonic anhydrase inhibitor, has shown potential in reducing loop gain without affecting other physiological OSA traits. In this protocol the investigators will evaluate the clinical efficacy of AZM add-on therapy to surgical procedures in patients with OSA.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Antwerp
• Treatments: Acetazolamide

Criteria

Inclusion Criteria:

• Diagnosis of moderate to severe OSA (i.e. 15≤ AHI <65 events per hour)

• Eligibility for either BRP or UAS surgery

• Fitness for general anesthesia (ASA ≤2)

• Capability of giving informed consent and willingness to undergo surgery

Exclusion Criteria:

• Craniofacial anomalies affecting the UA

• Body mass index (BMI) >35 kg/m²

• General contra-indications for surgery

• Central sleep apnea (defined as central AHI ≥5 events per hour)

• Contra-indications related to acetazolamide treatment

• Hypersensitivity to sulfonamides or acetazolamide

• Renal impairment (eGFR <60 ml/min/1.73m²), electrolyte imbalances (sodium levels <135 mmol/L or potassium levels <3.5 mmol/L) and/or adrenocortical insufficiency

• Clinically significant neurological, metabolic (including diabetes mellitus type 1 or 2), hepatic (alanine transaminase or aspartate transaminase >2 times the upper limit of normal) and/or hematological disease

• Chronic obstructive pulmonary disease

• Closed-angle glaucoma

• Professional driving or handling complex machinery due to the potential risk of exaggerated daytime sleepiness

• Concomitant intake of drugs that influence breathing, sleep, arousal and/or muscle physiology

• Inability of the patient to understand and/or comply to the study procedures

• Active psychiatric disease (psychotic illness, major depression, anxiety attacks, and alcohol or drug abuse) which prevents compliance with the requirements of the research setting

• Pregnancy or willing to become pregnant