Upper-airway stimulation for obstructive sleep apnea
Patrick J Strollo Jr, Ryan J Soose, Joachim T Maurer, Nico de Vries, Jason Cornelius, Oleg Froymovich, Ronald D Hanson, Tapan A Padhya, David L Steward, M Boyd Gillespie, B Tucker Woodson, Paul H Van de Heyning, Mark G Goetting, Oliver M Vanderveken, Neil Feldman, Lennart Knaack, Kingman P Strohl, STAR Trial Group, Sam Mickelson, Faraa Mobini, Mark Goetting, L Steven Szeles, Rebecca Timpe, Carol Moshier, Christopher Schneider, Christine McNett, Piérre Philip, Piérre-Jean Monteyrol, Céderic Valtat, Kingman Strohl, Robert Schilz, Jonathan Baskin, David Haney, Mary Andrews, Julie Heald, Joseph Roberson, Don Sesso, Jokasta Cordon, Frédéric Chabolle, Marc Blumen, Lia Guileré, Lennart Knaack, Jaroslaw Janicki, Christoph Möckel, Christian Tholen, Sabine Schäfer, B Tucker Woodson, Lauren Markowski, Sue Vacula, Christy Erbe, M Boyd Gillespie, Shaun Nguyen, Colin Fuller, Shivangi Lohia, Ryan Reddy, Jason Cornelius, Oleg Froymovich, Cindy Stein, Neil Feldman, Tapan Padhya, Mary O'Brien, Nico de Vries, Faiza Safiruddin, Linda Benoist, Tinneke De Bleser, Andrew Jamieson, Neil Williams, Chris Hassell, Ronald D Hanson, Troy Payne, Emily Jacobs, Kathy Gerads, Sarah Stolz, Chris Yang, Jeremy Gillis, Kathleen Butler, David Steward, Victoria Surdulescu, Jessica Keller, Joachim T Maurer, Clemens Anders, Oliver Schmidt, Ryan Soose, Patrick Strollo, Charles Atwood, John McCormick, Tapan Padhya, Mack Anderson, Laurie Joughlin, Paul H Van de Heyning, Olivier M Vanderveken, Wilfried A De Backer, Johan Verbraecken, Wim D'Hondt, Marijke Dieltjens, Winfried Randerath, Christina Priegnitz, Winfried Hohenhorst, Marcel Treml, M Safwan Badr, Ho-sheng Lin, Anita D'Souza, Teri Yurik, Kent Wilson, Markus Gapany, Sandra M Skovlund, Erik St Louis, Patrick J Strollo Jr, Ryan J Soose, Joachim T Maurer, Nico de Vries, Jason Cornelius, Oleg Froymovich, Ronald D Hanson, Tapan A Padhya, David L Steward, M Boyd Gillespie, B Tucker Woodson, Paul H Van de Heyning, Mark G Goetting, Oliver M Vanderveken, Neil Feldman, Lennart Knaack, Kingman P Strohl, STAR Trial Group, Sam Mickelson, Faraa Mobini, Mark Goetting, L Steven Szeles, Rebecca Timpe, Carol Moshier, Christopher Schneider, Christine McNett, Piérre Philip, Piérre-Jean Monteyrol, Céderic Valtat, Kingman Strohl, Robert Schilz, Jonathan Baskin, David Haney, Mary Andrews, Julie Heald, Joseph Roberson, Don Sesso, Jokasta Cordon, Frédéric Chabolle, Marc Blumen, Lia Guileré, Lennart Knaack, Jaroslaw Janicki, Christoph Möckel, Christian Tholen, Sabine Schäfer, B Tucker Woodson, Lauren Markowski, Sue Vacula, Christy Erbe, M Boyd Gillespie, Shaun Nguyen, Colin Fuller, Shivangi Lohia, Ryan Reddy, Jason Cornelius, Oleg Froymovich, Cindy Stein, Neil Feldman, Tapan Padhya, Mary O'Brien, Nico de Vries, Faiza Safiruddin, Linda Benoist, Tinneke De Bleser, Andrew Jamieson, Neil Williams, Chris Hassell, Ronald D Hanson, Troy Payne, Emily Jacobs, Kathy Gerads, Sarah Stolz, Chris Yang, Jeremy Gillis, Kathleen Butler, David Steward, Victoria Surdulescu, Jessica Keller, Joachim T Maurer, Clemens Anders, Oliver Schmidt, Ryan Soose, Patrick Strollo, Charles Atwood, John McCormick, Tapan Padhya, Mack Anderson, Laurie Joughlin, Paul H Van de Heyning, Olivier M Vanderveken, Wilfried A De Backer, Johan Verbraecken, Wim D'Hondt, Marijke Dieltjens, Winfried Randerath, Christina Priegnitz, Winfried Hohenhorst, Marcel Treml, M Safwan Badr, Ho-sheng Lin, Anita D'Souza, Teri Yurik, Kent Wilson, Markus Gapany, Sandra M Skovlund, Erik St Louis
Abstract
Background: Obstructive sleep apnea is associated with considerable health risks. Although continuous positive airway pressure (CPAP) can mitigate these risks, effectiveness can be reduced by inadequate adherence to treatment. We evaluated the clinical safety and effectiveness of upper-airway stimulation at 12 months for the treatment of moderate-to-severe obstructive sleep apnea.
Methods: Using a multicenter, prospective, single-group, cohort design, we surgically implanted an upper-airway stimulation device in patients with obstructive sleep apnea who had difficulty either accepting or adhering to CPAP therapy. The primary outcome measures were the apnea-hypopnea index (AHI; the number of apnea or hypopnea events per hour, with a score of ≥15 indicating moderate-to-severe apnea) and the oxygen desaturation index (ODI; the number of times per hour of sleep that the blood oxygen level drops by ≥4 percentage points from baseline). Secondary outcome measures were the Epworth Sleepiness Scale, the Functional Outcomes of Sleep Questionnaire (FOSQ), and the percentage of sleep time with the oxygen saturation less than 90%. Consecutive participants with a response were included in a randomized, controlled therapy-withdrawal trial.
Results: The study included 126 participants; 83% were men. The mean age was 54.5 years, and the mean body-mass index (the weight in kilograms divided by the square of the height in meters) was 28.4. The median AHI score at 12 months decreased 68%, from 29.3 events per hour to 9.0 events per hour (P<0.001); the ODI score decreased 70%, from 25.4 events per hour to 7.4 events per hour (P<0.001). Secondary outcome measures showed a reduction in the effects of sleep apnea and improved quality of life. In the randomized phase, the mean AHI score did not differ significantly from the 12-month score in the nonrandomized phase among the 23 participants in the therapy-maintenance group (8.9 and 7.2 events per hour, respectively); the AHI score was significantly higher (indicating more severe apnea) among the 23 participants in the therapy-withdrawal group (25.8 vs. 7.6 events per hour, P<0.001). The ODI results followed a similar pattern. The rate of procedure-related serious adverse events was less than 2%.
Conclusions: In this uncontrolled cohort study, upper-airway stimulation led to significant improvements in objective and subjective measurements of the severity of obstructive sleep apnea. (Funded by Inspire Medical Systems; STAR ClinicalTrials.gov number, NCT01161420.).
Source: PubMed