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"At every point in this study I asked them would they do this again, and they all said 'yes'," says Dr. Strohl. "They also said they are having the best sleep, they are not as sleepy during the day, they feel more productive, etc." He points out that even the t wo patients who did not have large reduc- tions in their AHI continue to use the device and feel that it has improved both their snoring and their daytime functioning. In essence, for the right patients, Inspire seems to produce results comparable to CPAP. However, compared to CPAP it is invasive and not without its own risk of infection or site problems, so it remains now an option for those who cannot or will not use CPAP. Patient Selection Careful patient selection is key to the best outcome with Inspire. For this reason, patients must go through a multi-step process to qualify. In addition to having moderate to severe obstructive sleep apnea with an Apnea Index of 20 to 60 (levels associated with a risk for serious health problems), patients must also have a BMI of less than 35 and an inability or disinclination to tolerate CPAP or other treatment approaches. "We look at their current therapy and make sure that they have the benefit of the educational process to optimize that therapy," says Dr. Strohl. "If that has been addressed and the patient still fails, then we go on." Patients who meet these criteria and are healthy enough to undergo surgery are further evaluated with an endo- scopic sleep study, which reveals the exact nature and location of a patient's airway obstruction. This ensures that the only patients treated w ith the The Inspire system consists of three components: a lead implanted in the neck area which attaches to the hypoglossal nerve, a breathing sensor which attaches to the diaphragm, and a neurostimulator or pacemaker that goes in the chest area. The patient controls the system with a small handheld programmer. ILLUSTRATION COURTESY OF INSPIRE MEDICAL SYSTEMS INC. Inspire device are those for whom it is most likely to make a real difference. "By simulating sleep and then snaking a camera in through the nose, we can see if the targeted area for the implant is actually in a place where it is going to be able to help them," says Dr. Ponsky. Data from the STAR trial revealed that patients who exhibited a concentric collapse of the vesophar ynx during drug-induced sleep endoscopy tended to have suboptimal results with Inspire, while those who had anterior posterior collapse of the airway from the tongue base prolapse were most successful. A patient whose anatomy, history, and sleep study indicate he or she would be a good candidate for Inspire is then referred for implantation. About a month after the Inspire device is in place, the patient returns to the UH clinic where a sleep medicine specialist activates the device first during wakefulness. Another sleep study is performed after the patient uses the device at home for a week or so, to adjust more precisely the settings for best results. The Future of Inspire at UH Once an Inspire device is implanted, it continues to gather data – such as how long it is being used every night – to help doctors evaluate outcomes. While the patient sample size of the STAR trial was too small to determine whether or not Inspire might also reduce the risk of cardiovascular problems in people with OSA, Dr. Strohl says the Phase III study did reveal important new informa- tion about obstructive sleep apnea that may lead to further improvements in its treatment. "The major thing this therapy has shown us is the role of neural activa- tion in the pathogenesis of sleep apnea and how nerves control upper airway patency," says Dr. Strohl. "This dem- onstration opens the pathway for other therapies or improvement in therapies that activate nerves, even with anatomic risk factors in place. By selective stimu- lation of the nerve, we can eliminate sleep apnea even though a person may be heavy or have a large tongue." Nearly 200 people attended an infor- mational meeting at UH about Inspire in the lead-up to the STAR trial, suggesting that many Northeast Ohio residents with OSA are ready for an alternative to CPAP. Doctors who have patients they believe may be candidates for Inspire can refer them for an evaluation by a UH sleep medicine specialist. F o r m o r e i n f o r m a t i o n a b o u t S l e e p M e d i c i n e a t U n i v e r s i t y Hospitals Case Medical Center, visit UHhospitals.org/sleepsound. To refer a possible patient candidate for Inspire Uppe r Air wa y St imulat ion the rap y, call Universit y Hospitals Sleep Center at 216-844-5128 or 866-UH4-CARE and mention the word "Inspire". ■ 2 0 1 4 N OV E M B E R / D E C E M B E R ■ M D N E W S . CO M ■ MD NEWS Cleveland/Akron/Canton | 1 5

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