Hypoglossal Nerve Stimulation in Obstructive Sleep Apnea With Complete Concentric Collapse
Key facts
- Where
- Boston, United StatesSee the 2 sites
Where in United States
- Brigham and Women's HospitalBoston, United StatesContact: Daniel Vena, PhDNo longer taking part
- Massachusetts Eye and EarBoston, United StatesContact: Daniel Vena, PhDNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Brigham and Women's Hospital
- Trial code
- NCT07898618
- Record updated
- 27 October 2026
- Original description
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.Read full original descriptionShow less
Physiological and Anatomical Determinants of Hypoglossal Nerve Stimulation Outcomes in Complete Concentric Collapse Investigational Cohort
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.
Inclusion: 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 consent; Willingness to undergo investigational HGNS implantation and required follow-up procedures under the research protocol.
Exclusion: Prior HGNS implantation; Contraindications to HGNS implantation or conditions that, in the judgment of the treating clinicians or investigators, make investigational HGNS use unsafe or inappropriate; Any unstable or uncontrolled medical condition that, in the judgment of the investigator, would increase procedural risk or interfere with study participation; Central or mixed sleep apnea comprising >25% of total respiratory events; Inability to safely undergo study procedures, including overnight sleep studies or physiological monitoring; Pregnancy.