Patients Sought for Clinical Trial Investigating Pill to Treat Sleep Apnea

SPRINGFIELD — Many of the approximately 39 million U.S. adults with sleep apnea cannot tolerate its treatment using a CPAP machine. Now, researchers at Baystate Medical Center are looking for patients to participate in a clinical trial to see whether a pill to treat sleep apnea is safe and effective. For years, researchers have been trying to come up with such a pill.

“While it is likely that medications will not fully treat obstructive sleep apnea (OSA), there is hope that it can lead to at least a partial improvement of symptoms and less risks of untreated sleep apnea,” said Dr. Karin Johnson, director of the Baystate Health Sleep Program. “So far, the most promising medications have been ones which reduce the relaxation of the tongue, helping to keep the airway more open during sleep, but they work best when combined with other medications that help stabilize sleep.”

One possible drug is getting closer to becoming a reality. Late in 2022, Apnimed announced the results of its phase-2 randomized trial studying a new drug combination, AD109, which demonstrated initial success in decreasing the number of blockages in the airflow in patients with OSA and improving their fatigue scores. The drug combines atomoxetine, a medication that has been used for many years for ADHD, with aroxybutynin, a new formulation of oxybutynin, a medication that is used to treat overactive bladder.

Apnimed recently opened its phase-3 trial, LunAIRo, which is currently enrolling patients into a one-year study to confirm the safety and efficacy of this medication. LunAIRo is a placebo-controlled trial, meaning active medication in some patients will be compared to a sugar pill in others.

“Baystate Medical Center is excited to be part of this study that will hopefully bring a new treatment option to our patients with OSA,” Johnson said. “By taking part in this research, patients have the opportunity to be the first to try this potential treatment and help advance science. No insurance coverage is needed, and all study costs are covered.”

Baystate is looking for adults with OSA who have not used CPAP for at least three months or no longer have a CPAP machine at home and have sleepiness or fatigue related to their OSA. The trial will involve several sleep studies and assessments throughout the year.

Patients who are interested in learning more about participating in the study should visit www.baystatehealth.org/sleepstudy.