DReAMzz- Dronabinol and Acetazolamide Medication for Sleep Apnea (ZZ). Dose Confirmation Crossover Study for IHL-42X in Subjects With Obstructive Sleep Apnea.
NCT07635563
This study is recruiting at 12 US sites in 7 states, according to its ClinicalTrials.gov record last updated .
Summary
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.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Obstructive Sleep Apnea (OSA)
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 2
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Sponsor
- Incannex Healthcare Ltd
- Last updated on ClinicalTrials.gov
- October 13, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
California · 1
- Exalt Clinical Research · Chula Vista, CA
Florida · 4
- Teradan Clinical Trials LLC · Brandon, FL
- CNS Healthcare - Jacksonville · Jacksonville, FL
- CNS Healthcare Orlando · Orlando, FL
- Palm Beach Research Center · West Palm Beach, FL
Maryland · 1
- Velocity Clinical Research, Rockville · Rockville, MD
Ohio · 2
- CTI Clinical Research Center · Cincinnati, OH
- Intrepid Research · Cincinnati, OH
South Carolina · 1
- Velocity Clinical Research, Anderson · Anderson, SC
Tennessee · 1
- CNS Healthcare - Memphis · Memphis, TN
Texas · 2
- FutureSearch Trials of Dallas · Dallas, TX
- Sleep Therapy & Research Center · San Antonio, TX
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.