NCT06540716

Inspire Singapore Study

Inspire Singapore Study: Confirmation of Therapy Performance

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Inspire Medical Systems, Inc. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

Prospective, multicenter, open-label study designed to confirm device performance of Inspire system in Singapore.

Detailed 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.

Conditions

• Obstructive Sleep Apnea
• OSA
• Sleep Apnea

Interventions

Type	Name	Description
DEVICE	Inspire System	Hypoglossal nerve stimulation therapy will be activated at approximately 1 month post-implant.

Timeline

• Start date: 2024-08-01
• Primary completion: 2025-08-01
• Completion: 2025-12-01
• First posted: 2024-08-06
• Last updated: 2024-08-19

Locations

2 sites across 1 country: Singapore

Regulatory

• FDA-regulated device study