NCT04457154

Pediatric Post-Approval Registry

Inspire Pediatric Post-Approval Registry

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Inspire Medical Systems, Inc. · Industry
• Sex: All
• Age: 18 Years – 21 Years
• Healthy volunteers: Not accepted

Summary

This registry is a prospective, multi-center, single-arm study of pediatric subjects (ages 18-21 years) who are undergoing implant of the Inspire Upper Airway Stimulation (UAS) System for the treatment of moderate or severe obstructive sleep apnea (OSA). Implanted subjects will be followed for 5 years post-implant.

Detailed description

This registry is a prospective, multi-center, single-arm study of pediatric subjects (ages 18-21 years) who are undergoing implant of the Inspire Upper Airway Stimulation (UAS) System for the treatment of moderate or severe obstructive sleep apnea (OSA). Implanted subjects will be followed for 5 years post-implant. Subjects will be recruited in accordance with the approved Inspire UAS indication for use and will only include those subjects who are within the new age indication (18-21 years of age). Implanted subjects must meet the registry eligibility criteria. Those subjects that are enrolled but fail to meet the eligibility criteria will be considered screen failures. This registry will collect safety and effectiveness data on 60 implanted subjects at a minimum of 5 qualified clinical centers in the United States. Study data will be collected at the following timepoints: Baseline (pre-implant) Implant Activation (1 month post-implant) 6 Months post-implant 1, 2, 3, 4, 5 years post-implant

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DEVICE	Inspire Upper Airway Stimulation System	Implant of the Inspire Upper Airway Stimulation System

Timeline

• Start date: 2021-11-30
• Primary completion: 2027-12-01
• Completion: 2028-04-01
• First posted: 2020-07-07
• Last updated: 2025-02-25

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated device study