Inspire Upper Airway Stimulation Post-FDA Approval Study
The purpose of this study is to obtain additional long-term safety and efficacy data on the use of the Inspire Upper Airway Stimulation System to treat obstructive sleep apnea.
Palabras clave: Sleep Apnea, Sleep Disorder, Obstructive Sleep Disorder
Sitios de estudio
Keck Medical Center of USC 90089
- Men & Women
¿Qué hay involucrado?
All participants will undergo surgery to implant the Inspire® UAS System, a permanent therapy that consists of three components: an implantable pulse generator, a stimulation lead, and a sensing lead.
Limited compensation is available for completion of components of the 5-year study.
Only for the additional sleep studies (in-laboratory polysomnogram and home sleep studies) that are not routinely performed in patient care. All routine patient care costs, including surgery, are billed to medical insurance.
Criterios de inclusión
- Must be scheduled for Inspire Upper Airway Stimulation implantation to treat obstructive sleep apnea at Keck Medical Center of USC.
Criterios de exclusión
- There are no exclusion criteria
About This Study
This study is taking place at USC and additional sites around the country. As part of the study, each subject will be followed for 5 years from date of implant. The qualification process includes an in-lab PSG, surgical consultation, and a drug-induced sleep endoscopy procedure. This study will collect pre-operative baseline data including verification of ineffective CPAP treatment, sleep study findings, medical history and subject quality of life measures. In-lab polysomnogram sleep study data will be collected during the 2-month and 1 & 3 year follow-up visits, home sleep tests will be conducted and data collected at the 6-month and 2, 4, & 5 year follow-up visits.
Equipo del Programa
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