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 @ 1:25 AM
Ignite Modification Date:
2025-12-25 @ 1:25 AM
NCT ID:
NCT04639193
Eligibility Criteria:
Inclusion Criteria:
* BMI 18-40 kg/m2
* Untreated Moderate or Severe OSA (AHI during supine NREM sleep \>15/h) with a fraction of hypopneas \>25% of all events
Exclusion Criteria:
* Pregnancy
* Breastfeeding
* Prisoners
* Adherent with effective therapy for OSA
* Other known untreated sleep fragmenting disorder, such as periodic limb movement disorder, or narcolepsy
* Inability to sleep supine for overnight sleep studies
* Circadian rhythm disorder
* Unrevascularized coronary artery disease, angina, prior heart attack or stroke, congestive heart failure
* Uncontrolled hypertension (systolic blood pressure \>160mmHg, diastolic blood pressure \>95mmHg)
* Presence of tracheostomy
* Hospitalization within the past 90 days
* Prior peptic ulcer disease, esophageal varices, or gastrointestinal bleeding (\< 5 years)
* Prior gastric bypass surgery
* Chronic liver disease or end-stage kidney disease
* Active illicit substance use or \>2 oz daily alcohol use (i.e. \>2 12 oz bottles of beers, \>2 5 oz glasses of wine, \>2 1.5 oz glasses of hard liquor such as spirits, gin, whiskey, etc.)
* Psychiatric disease, other than well controlled depression/anxiety
* Cognitive impairment, inability to provide consent, or inability to complete research procedures (e.g. questionnaires that are only available/validated in English)
* Chronically using study drugs or drugs with similar pharmacodynamic effects (acetazolamide - carbonic anhydrase inhibitors, eszopiclone - benzodiazepine receptor agonists, venlafaxine - serotonin/norepinephrine reuptake inhibitors and other antidepressants)
* Regular use of medications known to affect control of breathing (opioids, benzodiazepines, theophylline)
* Contraindications to taking study drugs, including allergies to any of the drugs or sulfa allergy; concomitant use of antidepressants, opioids, sedatives/hypnotics, thiazide diuretics or angiotensin-receptor blockers; or severe nocturnal hypoxia (SpO2 nadir \<70% on diagnostic sleep study).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04639193
Study Brief:
Protocol Section:
NCT04639193