Randomized Double-Blind Crossover Trial of IHL-42X Dronabinol and Acetazolamide for Adults with Obstructive Sleep Apnea

What this Trial Is About

Researchers are evaluating the safety and effectiveness of IHL-42X in adults with obstructive sleep apnea OSA. This phase 2, randomized, double-blind, multi-dose crossover trial aims to compare different doses of IHL-42X, a combination of dronabinol and acetazolamide, to placebo. The study focuses on measuring changes in apnea-hypopnea index AHI4 after each 28-day treatment period to identify the optimal dose based on safety and efficacy. Participants will receive one of nine different IHL-42X dose combinations or a placebo, self-administered once daily about one hour before bedtime for four weeks. The trial consists of three four-way crossover studies, each testing different dronabinol doses combined with fixed acetazolamide doses. Each treatment period lasts 28 days, with participants switching between doses and placebo according to a Williams design. During the study, participants will undergo sleep studies polysomnography before and after each treatment period to assess apnea severity and oxygen levels. They will also complete questionnaires on sleep quality, fatigue, and global impressions of their condition. Researchers will monitor safety through adverse event reporting, physical exams, vital signs, laboratory tests, and ECGs. The total participation duration includes multiple 28-day treatment periods and follow-up assessments over approximately 140 days.

DReAMzz- Dronabinol and Acetazolamide Medication for Sleep Apnea (ZZ). Dose Confirmation Crossover Study for IHL-42X in Subjects With Obstructive Sleep Apnea.