CCHS participating in sleep apnea clinical trial

May 31, 2024

Dr. James Geyer, a professor of family, internal, and rural medicine with the College of Community Health Sciences and medical director of the College’s Institute for Rural Health Research, is a site leader for a national clinical trial seeking to help patients with obstructive sleep apnea.

Obstructive sleep apnea (OSA) occurs when throat muscles relax and block airways while a person sleeps causing irregular breathing patterns. Sleep is vital to good health and well-being, according to the National Institutes of Health.

“There is a massive number of people who have this problem,” said Geyer, who is board-certified in neurology and sleep medicine. “It (OSA) can happen to anybody but is more common in people who are overweight and who have other medical disorders, including hypertension and diabetes. Having long-term untreated sleep apnea can increase the risk of other health problems, such as heart attack, stroke, heart failure and even dementia.”

Geyer said the most common treatment for OSA is CPAP, a machine that uses mild air pressure to keep breathing airways open while a person sleeps.

The clinical trial Geyer is involved in, SynAIRgy, focuses on the investigational drug Apnimed, which has been shown in previous research studies to improve the abnormal breathing that occurs in OSA. Apnimed is a pill taken nightly before bedtime.

“There are currently no medications that are FDA approved for this condition,” said Geyer. “The study is looking at least 640 participants across the United States.”

At CCHS, the site for the Phase 3 clinical trial is the Institute for Rural Health Research, which also conducts research to improve the availability, accessibility and quality of health care in rural Alabama. A Phase 3 clinical trial seeks to show if a product offers a treatment benefit to a specific population. Nine participants are presently enrolled in the trial, and one is going through the enrollment process.

To be eligible for the study, participants must be 18 years of age or older, have OSA symptoms and are unable or unwilling to receive CPAP treatment.

The trial consists of seven visits. During the initial visit, participants go through the informed consent process where the risks and benefits of the study are explained. A research coordinator assists Geyer by helping participants complete online questionnaires, and by collecting blood work. Three of the seven visits involve overnight sleep to monitor participants’ OSA. Participants take Apnimed before each overnight sleep visit and complete questionnaires before and after they sleep.