Hypoglossal Nerve Stimulation in Obstructive Sleep Apnea With Complete Concentric Collapse
A legfontosabb adatok
- Hol
- Boston (Egyesült Államok)Mind a 2 helyszín megnézése
Helyszínek itt: Egyesült Államok
- Brigham and Women's HospitalBoston, Egyesült ÁllamokContact: Daniel Vena, PhDNo longer taking part
- Massachusetts Eye and EarBoston, Egyesült ÁllamokContact: Daniel Vena, PhDNo longer taking part
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- Brigham and Women's Hospital
- Azonosító
- NCT07898618
- A regiszteradat frissítve
- 2026. október 27.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
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.
Bevonási feltételek: 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.
Kizáró feltételek: 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.