Phase 2 Sleep Disorders Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults aged 21 years or older
• People diagnosed with moderate to severe obstructive sleep apnea, meaning their breathing stops or becomes disrupted 15 or more times per hour during sleep
• People whose sleep apnea is mostly obstructive, with fewer than 5 central or mixed breathing pauses per hour (a different type of sleep apnea)
• People who cannot tolerate CPAP machines — specifically, those who use them less than 2 hours per night on at least 5 nights per week
• People who cannot tolerate or are not good candidates for a dental mouth device used to treat sleep apnea
• People who have already agreed to have palate surgery as part of their regular medical care
• People with tonsil size rated 0 to 2 on a standard medical scale (not markedly enlarged tonsils)
• People whose sleep study (a camera-guided examination of the airway during sleep) shows that the tongue is not the main cause of airway blockage (confirm with trial site)
• People whose medications have been stable for at least 2 months
• People with a body mass index (a measure of body weight relative to height) below 35
• People without uncontrolled nasal blockage
• People who have not had previous throat surgery, except for tonsil removal
• People free from neurological, heart, or lung conditions
• People without a psychiatric disorder, except those with treated depression or mild anxiety
• People without other sleep disorders such as narcolepsy, chronic insomnia, or restless legs syndrome
• People who do not use sleeping pills, anti-anxiety medications, stimulants, or sedating antidepressants
• People who have not had a near-miss or actual car accident due to sleepiness in the past 12 months
• People who drink fewer than 3 caffeinated beverages per day

Who may not be able to join:

• People who have previously had an allergic reaction to either of the two study medications
• People who have had a serious allergic reaction (such as Stevens-Johnson syndrome) to sulfonamide medications
• People with a known sensitivity or hypersensitivity to either of the two study medications
• People taking high-dose aspirin therapy, due to the risk of a serious metabolic side effect
• People with severe kidney disease or severe liver disease
• People with a history of electrolyte (body salt) imbalances or adrenal gland insufficiency
• People currently taking ketoconazole or other strong medications known as CYP3A4 inhibitors, which can raise the blood levels of one of the study drugs to unsafe levels (confirm with trial site)
• People who are pregnant
• People with a history of alcohol or substance abuse

Important: Always verify eligibility with the trial site directly before applying.