IHL-42X for Obstructive Sleep Apnea

(DReAMzz Trial)

This trial tests a new treatment called IHL-42X, which combines dronabinol and acetazolamide, for individuals with obstructive sleep apnea—a condition that causes breathing to stop and start during sleep. Researchers aim to determine if IHL-42X is safe and effective in reducing sleep apnea symptoms. Participants will try different doses over four weeks to identify the best combination. This study targets those who have had sleep apnea for some time, struggle with using a CPAP machine, and experience frequent sleep interruptions. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

The trial requires participants to stop using certain medications, such as benzodiazepines, sedative-hypnotics, stimulants, and other prescription medications for insomnia. If you are taking these, you will need to stop before joining the study.

Research has shown that IHL-42X, a mix of dronabinol and acetazolamide, is safe. One study found that participants tolerated IHL-42X well at low, medium, and high doses, with no serious side effects. Another study confirmed the treatment's safety and tolerability over 28 days. These studies suggest that IHL-42X is generally safe for people with obstructive sleep apnea, although individual experiences may differ.¹²³⁴⁵

Researchers are excited about IHL-42X for obstructive sleep apnea because it combines dronabinol, a synthetic form of THC, with acetazolamide, a diuretic. This unique combination targets the condition differently from traditional treatments like CPAP machines or oral appliances. Dronabinol influences the brain's sleep-wake cycle, while acetazolamide can help reduce sleep apnea events by altering blood chemistry. This dual-action approach offers a potentially new way to manage obstructive sleep apnea, providing an alternative for those who struggle with or prefer not to use current standard treatments.

Studies have shown that IHL-42X, a combination of dronabinol and acetazolamide, can significantly reduce the severity of obstructive sleep apnea (OSA). One study demonstrated that IHL-42X decreased the number of breathing interruptions during sleep by up to 83% in participants taking a high dose and by 79% in those taking a low dose. Another study found that the smallest dose reduced these interruptions by an average of 51%. This trial will evaluate various dosages of IHL-42X, and these findings suggest that IHL-42X can effectively improve sleep quality for people with OSA.¹²³⁵⁶