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Hypoglossal Nerve Stimulation in Obstructive Sleep Apnea With Complete Concentric Collapse
Sponsor: Brigham and Women's Hospital
Summary
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.
Official title: Physiological and Anatomical Determinants of Hypoglossal Nerve Stimulation Outcomes in Complete Concentric Collapse Investigational Cohort
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2026-12-01
Completion Date
2031-06-01
Last Updated
2026-10-27
Healthy Volunteers
No
Conditions
Interventions
Inspire Hypoglossal Nerve Stimulation System
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.
Locations (2)
Massachusetts Eye and Ear
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States