USF ENT part of leading study on an alternative sleep apnea therapy

         -Study results published in recent New England Journal of Medicine-

A recent New England Journal of Medicine article reporting that upper airway stimulation reduces the severity of obstructive sleep apnea included the USF Health Morsani College of Medicine as a site in the international clinical study.

Tapan Padhya, MD, professor and director of the Division of Head and Neck Oncology and co-director of the multidisciplinary USF ENT Sleep and Snoring Clinic, was one of the investigators for the trial conducted at 22 leading medical centers across the United States and Europe.

Dr. Padhya led the USF arm of the Stimulation Therapy for Apnea Reduction (STAR) Trial at Tampa General Hospital, and was among the authors of the study results published Jan. 9 in the NEJM.

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Tapan Padhya, M.D, led the USF-TGH arm of the international sleep apnea stimulation therapy study.

The researchers tested an implantable device delivering mild electronic stimulation to the upper airway during sleep to prevent the tongue from collapsing and obstructing the airway.  The Inspire™ Upper Airway Stimulation device was implanted in patients who were unable to accept or adhere to sleep apnea treatment with a bedside machine known as CPAP, which provides continuous positive airway pressure to keep upper airways open.

The alternative therapy worked well in reducing interruptions in sleep, alleviating the symptoms of obstructive sleep apnea including snoring and daytime drowsiness, and improving quality of life.

While several options – including a various upper airway surgeries and custom-made removable oral appliances – area available for treating sleep apnea, CPAP has been the gold standard treatment for people with moderate to severe sleep apnea.  But, its effectiveness depends on patient compliance, and some people have trouble adjusting to sleeping with system’s face mask and head strap, so adherence to the regimen can be poor.

“CPAP is still the gold standard,” Dr. Padhya said, “but this (implantable device) technology is an extremely effective treatment option for a broad swath of patients who are unable to use or won’t tolerate the mask.”

The technology for the Inspire™  implant is similar to that used in cardiac pacemakers.  The system is designed to be permanent with a change of the stimulator’s battery every seven to nine years.

The study published in NEJM “definitely addresses a sweet spot for research to benefit the undertreated sleep apnea population,” said Dr. Padhya, adding that USF was one of the top sites in the country for recruiting study participants.

“Our participation in a study at this level highlights the value of the academic partnership between USF Health and TGH in collaborating to address important research questions with applications for advances in patient care.”

More than 18 million Americans suffer from obstructive sleep apnea, characterized by repeat episodes of upper airway collapse during sleep in which patients frequently stop breathing for a minute or longer.  The sleep disorder can lead to daytime sleepiness, depression, weight gain, industrial accidents, reduced productivity and diminished quality of life.

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Dr. Tapan Padhya, right, and Dr. David Smith, chair of the USF Health Morsani College of Medicine’s Department of Surgery, operate on a patient with obstructive sleep apnea.