JANUARY 9, 2014 | Patrick J. Strollo, Jr., M.D., Ryan J. Soose, M.D., Joachim T. Maurer, M.D., Nico de Vries, M.D., Jason Cornelius, M.D., Oleg Froymovich, M.D., Ronald D. Hanson, M.D., Tapan A. Padhye, M.D., David L. Steward, M.D., M. Boyd Gillespie, M.D., B. Tucker Woodson, M.D., Paul H. Van de Heyning, M.D., Ph.D., Mark G. Goetting, M.D., Olivier M. Vanderveken, M.D., Ph.D., Neil Feldman, M.D., Lennart Knaack, M.D., and Kingman P. Strohl, M.D., for the STAR Trial Group
This study evaluated the clinical safety and effectiveness of upper-airway stimulation at 12 months for treating moderate-to-severe obstructive sleep apnea in patients who struggled with adherence to continuous positive airway pressure (CPAP) therapy. The study included 126 participants, with a mean age of 54.5 years and a mean body-mass index (BMI) of 28.4. The primary outcomes were the apnea-hypopnea index (AHI) and oxygen desaturation index (ODI), which showed significant reductions at 12 months (AHI: 68% decrease; ODI: 70% decrease). Secondary outcomes, including the Epworth Sleepiness Scale and the Functional Outcomes of Sleep Questionnaire (FOSQ), also demonstrated improvements. A randomized, controlled therapy-withdrawal trial further confirmed the effectiveness of upper-airway stimulation, with a significant increase in AHI scores in the group that discontinued therapy. The overall rate of serious adverse events was less than 2%. The study concluded that upper-airway stimulation is a safe and effective treatment for moderate-to-severe obstructive sleep apnea, providing significant improvements in both objective and subjective measures of severity.This study evaluated the clinical safety and effectiveness of upper-airway stimulation at 12 months for treating moderate-to-severe obstructive sleep apnea in patients who struggled with adherence to continuous positive airway pressure (CPAP) therapy. The study included 126 participants, with a mean age of 54.5 years and a mean body-mass index (BMI) of 28.4. The primary outcomes were the apnea-hypopnea index (AHI) and oxygen desaturation index (ODI), which showed significant reductions at 12 months (AHI: 68% decrease; ODI: 70% decrease). Secondary outcomes, including the Epworth Sleepiness Scale and the Functional Outcomes of Sleep Questionnaire (FOSQ), also demonstrated improvements. A randomized, controlled therapy-withdrawal trial further confirmed the effectiveness of upper-airway stimulation, with a significant increase in AHI scores in the group that discontinued therapy. The overall rate of serious adverse events was less than 2%. The study concluded that upper-airway stimulation is a safe and effective treatment for moderate-to-severe obstructive sleep apnea, providing significant improvements in both objective and subjective measures of severity.