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NOT YET RECRUITING
NCT07898618
NA

Hypoglossal Nerve Stimulation in Obstructive Sleep Apnea With Complete Concentric Collapse

Sponsor: Brigham and Women's Hospital

View on ClinicalTrials.gov

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

Interventions

DEVICE

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