Brigham and Women's Hospital
This study examines how hypoglossal nerve stimulation affects breathing and sleep apnea in adults whose airway closes from all sides at the soft palate during sleep, a pattern called complete concentric collapse. Participants will receive an Inspire hypoglossal nerve stimulation implant and undergo sleep studies, questionnaires, and home monitoring. This use of the device is investigational. The study will measure changes in airway collapsibility, sleep apnea severity, device use, and safety through 12 months after implantation.
This prospective, single-center, open-label investigational cohort will enroll up to 20 adults with obstructive sleep apnea and complete concentric collapse of the soft palate on clinically obtained drug-induced sleep endoscopy. Research assessments occur at Brigham and Women's Hospital; implantation occurs at Massachusetts Eye and Ear. Investigational implantation is conducted under FDA IDE G260193. All enrolled participants receive the intervention; there is no randomization or separate treatment comparison arm. Baseline eligibility requires attended laboratory polysomnography before implan…
Inclusion Criteria: * Age ≥18 years. * Diagnosis of obstructive sleep apnea with an apnea-hypopnea index (AHI) ≥15 events/hour, confirmed by attended in-laboratory polysomnography (PSG) before enrollment and implantation. * Complete concentric collapse (CCC) of the soft palate on clinically obtained drug-induced sleep endoscopy (DISE). * Otherwise considered an appropriate candidate for HGNS implantation by the treating surgical and sleep medicine team, aside from CCC status. * Prior CPAP failure or intolerance, consistent with usual HGNS candidacy evaluation. * Ability to provide informed co…
Implanted hypoglossal nerve stimulation for obstructive sleep apnea in participants with complete concentric collapse. The system is activated approximately four weeks after implantation and titrated approximately three months after implantation. Stimulation is briefly turned on and off during physiological measurements. Participants withhold HGNS for four nights before the physiological sleep study and resume usual treatment after testing.
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