The goal of this randomized, double-blind, multi-dose crossover clinical trial is to determine the safety and efficacy of IHL-42X in subjects with obstructive sleep apnea.
The primary endpoint is: Change in AHI4 at the end of each treatment period compared to baseline (each treatment period is 28 days).
The study will consist of three separate four-way crossover dose-comparison studies each comparing three dose strengths of IHL-42X to placebo. The double-blind four-way crossover will be conducted according to a Williams design. Each of the crossover studies will test different doses of dronabinol in combination with a distinct, set dose of acetazolamide. In total, nine different combinations of dronabinol and acetazolamide formulated as IHL-42X will be tested in the study. The optimal dose strength will be selected based on safety and efficacy over a 4-week treatment period.
Aged ≥18 and ≤65 years of age at the time of consent.
AHI4 ≥5
≤25% central or mixed apneas out of total AHI
no Cheyne-Stokes respiration
Body mass index (BMI) >40 kg/m2 (men) and >42 kg/m2 (women).
Diagnosed obesity hypoventilation syndrome or hypercapnia.
PAP-compliant, defined by use of PAP for ≥4 hours for at least 63 nights during the consecutive 90-day period.
Current use of custom-made oral appliances (mandibular advancement device, tongue retaining device, or mouth guard) or hypoglossal nerve stimulation devices. Devices must not be used for the duration of the study.
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Treatment groupsSee each treatment group below.