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Tampa General Hospital and USF Health’s part in International Clinical Trial leads to FDA approval of Sleep Apnea Device

Published: May 1, 2014

By Tampa General Hospital


May 1, 2014 (Tampa, FL) - People that suffer from moderate to severe sleep apnea now have a new option to address nighttime breathing problems.  It’s the first kind of device that keeps airways open by sending a mild electrical shock to prevent the tongue from relaxing and obstructing the airway. Today the Food and Drug Administration approved the pacemaker-like device from Inspire Medical Systems for sleep apnea patients who have trouble with the current standard of care, the C-PAP machine. The C-PAP, which blows air through a bedtime mask, has traditionally been the first-choice treatment for sleep apnea. But studies have shown that C-PAP patients don’t use it consistently, the masks can fit poorly or can make the user feel claustrophobic. The new sleep apnea implantable device treats the problem by stimulating a nerve that controls key airway muscles so they stay in place, rather than moving and interfering with the breathing. One of the main causes of sleep apnea is that the tongue and throat muscles relax too much during sleep and can block breathing and wake the patient. People who suffer from sleep apnea lose important deep sleep time and can put them at higher risk for accidents, heart attack and stroke. Tampa General Hospital was the only Florida site and one of 22 total sites that participated in the Stimulation Therapy for Apnea Reduction (STAR) international trial.  (Only one other Florida site screened patients, but did not implant the device for the trial.)  The TGH/USF Health trial investigator was Tapan Padhya, Tampa General Hospital surgeon and professor and director of the Division of Head and Neck Oncology and co-director of the multidisciplinary USF ENT Sleep and Snoring Clinic.  He was among the authors of the study results published earlier this year in the New England Journal of Medicine.  “I am especially proud of the joint research effort by our TGH and USF teams in helping bring a very exciting new technology to the sleep apnea sufferer.  As the inaugural center in the state of Florida, I look forward to helping my fellow sleep apnea patients," said Dr. Padhya. Between 12 and 18 million Americans suffer from sleep apnea, according to the National Institutes of Health and it’s more common in overweight, middle-aged men, but anyone can have it.