DReAMzz- Dronabinol and Acetazolamide Medication for Sleep Apnea (ZZ). Dose Confirmation Crossover Study for IHL-42X in Subjects With Obstructive Sleep Apnea.
Eligible age
18–65 yrs
Accepts
All genders
Locations
8 states
Healthy volunteers
No
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About this study
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.
Sponsor: Incannex Healthcare Ltd
You may qualify if…
- ✓ Participants must satisfy all the following criteria at screening unless otherwise stated:
- ✓ 1. Aged ≥18 and ≤65 years of age at the time of consent.
- ✓ 2. Two screening PSG findings confirmed on central over-read that both must meet the below criteria:
- ✓ 1. AHI4 ≥5
- ✓ 2. ≤25% central or mixed apneas out of total AHI
- ✓ 3. no Cheyne-Stokes respiration
- ✓ 4. total sleep time ≥ 4 hours in each PSG
- ✓ 5. \< 30 periodic leg movement disorder arousals per hour.
You may not qualify if…
- ✕ Participants will be excluded from the study if they satisfy any of the following criteria at screening, unless otherwise stated:
- ✕ 1. Body mass index (BMI) \>40 kg/m2 (men) and \>42 kg/m2 (women).
- ✕ 2. Diagnosed obesity hypoventilation syndrome or hypercapnia.
- ✕ 3. PAP-compliant, defined by use of PAP for ≥4 hours for at least 63 nights during the consecutive 90-day period.
- ✕ 4. 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.
- ✕ 5. Maxillomandibular advancement, upper airway, or bariatric surgery within the last 6 months prior to first administration of the study drug; or participants who are planning surgical treatment.
- ✕ 6. Have commenced glucagon-like peptide-1 receptor agonist therapy within the last 6 months.
- ✕ 7. Use of benzodiazepines, sedative-hypnotics or stimulants (Anatomical Therapeutic Chemical \[ATC\] N06B, N05C, N05BA, N03AE, and N01AF categories) to treat insomnia, OSA, and other sleep disorders, or other disorders that require the drug to be taken prior to sleep.
Where it's recruiting
Chula Vista
Brandon · Jacksonville · Orlando · West Palm Beach …
Marrero
Rockville
Cincinnati
Anderson
Memphis
Dallas · San Antonio
Source: ClinicalTrials.gov · NCT07635563 · last updated 2026-07-27