Clinical Study for Obstructive Sleep Apnea (OSA)

*Archived*
Study No Longer Active

Obstructive Sleep Apnea Study

We need your help investigating how safe and effective a treatment, IHL-42X, is in people with OSA who are not having their disease adequately treated with positive airway pressure (PAP).

This includes people who have a PAP device but are not using it regularly, people who have tried a PAP device but decided it was not for them, and people who have refused to try a PAP device to treat their OSA.

About this Obstructive Sleep Apnea Study

The sleep study is designed for people with sleep apnea who are over 18 years of age. The purpose of this study is to see how safe and effective IHL-42X, a treatment taken by mouth, is in patients with moderate to severe OSA who have not benefited from treatment with PAP. This includes patients who do not tolerate or refuse PAP due to discomfort with the masks, inconvenience with the machines and associated maintenance, potential disruption to bed partners sleep due to noise of the machine and a host of other reasons.

You may be able to take part in the study if you:

  • You are aged 18 years or older
  • You have been diagnosed with moderate to severe Obstructive Sleep Apnea
  • Have refused, have not tolerated, or have not complied with PAP treatment
  • Receive compensation up to $1,480 for inconvenience and travel

If you are interested in participating, the study doctor and staff will review additional eligibility criteria with you and answer any questions you may have.

Complete The Questionnaire Below To Submit Your Information For Future Studies

Study Overview

If eligible for this study, you may receive:

• Study-related medical care
• Study-related lab tests and procedures

This clinical trial is studying the effectiveness of an investigational treatment for individuals with moderate to severe obstructive sleep apnea (OSA) who have not experienced improvement with positive airway pressure (PAP) therapy. This encompasses patients who encounter difficulties with PAP, such as discomfort with masks, inconvenience with machine usage and maintenance, potential disturbance to bed partners’ sleep due to machine noise, and various other reasons. Your assistance is requested in spreading the word about our study to OSA patients who are not undergoing treatment with PAP. Such studies play a crucial role in the development of new treatment options for individuals coping with a range of conditions, including OSA.

OSA, the narrowing or obstruction of the upper airway in sleep, affects approximately 936 million adults worldwide. While PAP stands as the standard treatment for OSA, it is effective when used properly, yet it exhibits low long-term compliance rates.

IHL-42X, a medication taken by mouth, is currently under investigation for the treatment of individuals who do not achieve compliance with PAP. This compound combines two medicines already approved for the treatment of conditions other than OSA: dronabinol and acetazolamide. Through this Phase III study, we aim to gain a better understanding of the safety and efficacy of treatment with IHL-42X.

Study Purpose

Standard treatment for OSA is the use of a PAP device. It is effective when used properly, however it has low long-term compliance rates. IHL-42X is a medication taken by mouth that is being investigated for treatment of individuals who are not compliant with PAP. It is a combination of two medicines already approved for treatment of conditions other than OSA: dronabinol – a pharmaceutical form of tetrahydrocannabinol (THC; the main psychoactive cannabinoid found in cannabis or marijuana), and acetazolamide – a drug that is approved for the treatment of a number of conditions including glaucoma, edema, and altitude sickness. We are conducting this Phase III study to investigate the effect of IHL-42X compared to dronabinol, acetazolamide and placebo. We hope that by conducting this study, we will better understand how safe and effective treatment with IHL-42X is.

Better Sleep

Dronabinol, a synthetic form of THC, exhibits great potential in treating sleep apnea, and recent advancements by pharmaceutical companies indicate its effectiveness.

A potential breakthrough in the treatment of obstructive sleep apnea (OSA) is on the horizon with the development of a new pill. One of the leading contenders is dronabinol, a synthetic version of the cannabinoid tetrahydrocannabinol (Marijuana/THC). This molecule, cost-effective to manufacture and conveniently administered in gel capsule form, holds promise as a viable option for individuals with sleep apnea who struggle with continuous positive airway pressure (CPAP) therapy.

How Obstructive Sleep Apnea (OSA) affects your health

People with OSA have pauses in their breathing during sleep, called apneas, when the muscles in their throat relax with sleep and block normal breathing. As a result, the quality of sleep may worsen, and lead to feeling overly tired during the day.

If you have OSA, you may experience fatigue and sleepiness, making it difficult to function at work and at home. This could have a negative impact on your life.

Over the long term, OSA can also lead to serious chronic health consequences. OSA can lower oxygen levels in your blood and make conditions such as diabetes, high blood pressure or hypertension worse. Long term, untreated OSA may increase a person’s risk of strokes and heart attacks.

Complete The Questionnaire Below
To Enroll in This Study

Frequently Asked Questions

Can I take other medication during the study?

Any other medication you are receiving at the time of enrollment must be recorded. You will not be allowed to receive high dose salicylates (aspirin and drugs related to aspirin), hypnotic sedatives (such as benzodiazepines and Z-drugs), stimulants (such as modafinil) and certain other drugs that may interfere with the metabolism of the investigational product throughout your participation in the study.

How will I record information on the study drug?

You will be given an e-Diary on your first day of the treatment period. We will give you training on what information you need to record on a daily basis.

The investigational product includes THC, will this affect my ability to drive?

THC is the main psychoactive molecule in cannabis and can affect one’s ability to drive and complete other complex tasks. IHL-42X has been designed to minimize the dose of THC and reduce the psychoactive effects. However, everyone responds differently to the drug. You will be asked to refrain from driving until you know how the drug affects your ability to think and drive. Laws about driving with THC in one’s system vary from country to country and state to state. Make sure that you discuss the potential legal ramifications of driving while taking a THC-containing product with the study doctor.

Can I stop taking part if I like?

Your participation in the study is entirely your choice. You are free to leave the study at any point and for any reason.