Overview
Prospective, multicenter, open-label study designed to confirm device performance of Inspire system in Singapore.
Description
Patients who meet study eligibility criteria will be implanted with an Inspire system and followed for 6 months post-therapy-activation. Study subjects will undergo in-lab sleep studies to confirm inspiratory overlap (1st PSG, after therapy activation), titrate the therapy (2nd PSG, at 3 months post-activation) and confirm therapy performance (3rd PSG, at 6 months post-activation). Symptoms and quality of life (assessed by ESS and FOSQ), therapy adherence, and adverse events will also be collected and reported.
Eligibility
Main Inclusion Criteria:
- Diagnosis of moderate to severe OSA (AHI 15-65)
- Failure of, or intolerance to CPAP
Main Exclusion Criteria:
- Central + mixed apneas > 25% of total AHI
- Presence of complete concentric collapse (CCC)
- Compromised neurological control of the upper airway.
Other eligibility criteria may apply.