Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 1:14 AM
NCT ID:
NCT04227093
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04227093
Study Brief:
Protocol Section:
NCT04227093