Research and Patient Advocacy at Heart of UH Sleep Medicine Care
February 18, 2024
UH Clinical Update | February 2024
Obstructive sleep apnea (OSA) is very common, but the long-term consequences of this sleep disorder remains poorly understood. Although the condition affects 34% of American men and 17% of American women between the ages of 30 and 70, questions about long-term impacts beyond sleepiness and sleep-related quality of life remain. There are also basic questions outstanding about how patients with OSA access care and are started on treatment, as up to 80% of individuals remain undiagnosed or untreated.
Susheel P. Patil, MD, PhDUH Sleep Medicine System Director Susheel P. Patil, MD, PhD, is a leading voice on all these issues.
Crucial Advocacy
Dr. Patil, for example, was recently asked to lead an international coalition of sleep medicine specialists and patient groups to respond to a draft report from the Agency for Healthcare Research and Quality (AHRQ). The report, which was geared to look at long-term impacts of OSA, downplayed the role of CPAP therapy in decreasing sleepiness and other related symptoms.
“These are the outcomes most sleep medicine professionals and patients with OSA find very important,” he says “Our unified letter endorsed by 21 professional and patient societies and comments by other stakeholders during the public comment period criticized the draft version of the AHRQ report for failing to clearly acknowledge the established therapeutic benefits of the treatment of OSA for excessive sleepiness, sleep-related quality of life, motor vehicle accidents, and blood pressure. The overall message conveyed by the final version of the AHRQ report, intentional or not, was that there were no significant benefits, short term or long term, of CPAP treatment.
The AHRQ draft report changed little in its final version. But Dr. Patil says it was still important to engage on the issues.
“Taken the wrong way, it could adversely affect decision-making when it came to policies at the federal level or payers,” he says.
In the wake of the AHRQ report, Dr. Patil co-authored two publications addressing it – an American Thoracic Society workshop report on approaches to study designs for addressing the impact of OSA on long-term health outcomes, as well as a multi-society report in the Journal of Clinical Sleep Medicine detailing the limitations of the AHRQ report.
Promoting Access
In addition to his scientific advocacy work, Dr. Patil has recently published a study detailing the five different care pathways an OSA patient experiences before finally receiving treatment, including which path costs the patient the least time and money. Fastest? Split-night testing. Cheapest? Home Sleep Apnea Test (HSAT).
“This health services study may inform policymakers and health systems about best approaches for speeding the timeline for diagnosis and treatment initiation of OSA,” he says.
New Therapies
Dr. Patil has also published a study examining whether OSA patients would tolerate a 20-minute session of daytime transoral neuromuscular stimulation of the tongue at different levels – an emerging treatment not currently covered by insurance. The study also showed that the higher stimulation level improved sleep apnea severity in those with mild sleep apnea.
“This is potentially now raising interest for the company to think about doing a multicenter trial to see whether this clearly improves sleep apnea severity,” he says.
Dr. Patil is also currently offering his OSA patients access to a clinical trial of a next-generation hypoglossal nerve stimulation device manufactured by LivaNova, called the aura6000 – implanted during a minor surgical procedure. And he soon will be enrolling OSA patients in a clinical trial of one of the first combination drugs designed to treat sleep apnea – AD109 – through the SynAirgy trial. AD109 is a combination of atomexetine, a drug used to commonly treat attention deficit hyperactivity disorder (ADHD), and a special formulation of oxybutynin (aroxybutynin), a bladder relaxant.
“In preliminary studies, it has shown efficacy in treating sleep apnea,” he says. “This is their pivotal trial to get FDA approval. It’s just one more option we can explore with our OSA patients.”