DReAMzz- Dronabinol and Acetazolamide Medication for Sleep Apnea (ZZ). Dose Confirmation Crossover Study for IHL-42X in Subjects With Obstructive Sleep Apnea.
Public ClinicalTrials.gov record NCT07635563. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase II, Randomized, Double-Blind, Multidose Crossover Clinical Trial to Determine the Safety and Efficacy of IHL-42X in Subjects With Obstructive Sleep Apnea
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07635563
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 120 participants
Conditions and interventions
Conditions
Interventions
- IHL-42X: 2.5 mg dronabinol + 125 mg acetazolamide Drug
- IHL-42X: 5 mg dronabinol + 125 mg acetazolamide Drug
- IHL-42X: 7.5 mg dronabinol + 125 mg acetazolamide Drug
- IHL-42X: 2.5 mg dronabinol + 250 mg acetazolamide Drug
- IHL-42X: 5 mg dronabinol + 250 mg acetazolamide Drug
- IHL-42X: 7.5 mg dronabinol + 250 mg acetazolamide Drug
- IHL-42X: 2.5 mg dronabinol + 375 mg acetazolamide Drug
- IHL-42X: 5 mg dronabinol + 375 mg acetazolamide Drug
- IHL-42X: 7.5 mg dronabinol + 375 mg acetazolamide Drug
- Placebo: Negative control Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 20, 2026
- Primary completion
- Mar 31, 2027
- Completion
- Apr 30, 2027
- Last update posted
- Aug 12, 2026
2026 – 2027
United States locations
- U.S. sites
- 14
- U.S. states
- 8
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Exalt Clinical Research | Chula Vista | California | 91910 | Not yet recruiting |
| Teradan Clinical Trials LLC | Brandon | Florida | 33511 | Recruiting |
| CNS Healthcare - Jacksonville | Jacksonville | Florida | 32256 | Not yet recruiting |
| CNS Healthcare Orlando | Orlando | Florida | 32801 | Not yet recruiting |
| Palm Beach Research Center | West Palm Beach | Florida | 33409 | Recruiting |
| Conquest Research/Neurotrials | Winter Park | Florida | 32789 | Not yet recruiting |
| Tandem Clinical Research | Marrero | Louisiana | 70072 | Not yet recruiting |
| Velocity Clinical Research, Rockville | Rockville | Maryland | 20854 | Not yet recruiting |
| CTI Clinical Research Center | Cincinnati | Ohio | 45212 | Recruiting |
| Intrepid Research | Cincinnati | Ohio | 45245 | Not yet recruiting |
| Velocity Clinical Research, Anderson | Anderson | South Carolina | 29621 | Recruiting |
| CNS Healthcare - Memphis | Memphis | Tennessee | 38119 | Not yet recruiting |
| FutureSearch Trials of Dallas | Dallas | Texas | 75251 | Not yet recruiting |
| Sleep Therapy & Research Center | San Antonio | Texas | 78229 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07635563, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 12, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07635563 live on ClinicalTrials.gov.