Acetazolamide Add-On Therapy to OSA Surgery (NCT04227093) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Acetazolamide Add-On Therapy to OSA Surgery
Belgium26 participantsStarted 2020-01-22
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
*…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.