Adherence and Outcome of Upper Airway Stimulation (UAS) for OSA International Registry

NCT02907398 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 5000

Last updated 2025-06-19

No results posted yet for this study

Summary

Inspire intends to conduct this registry to: 1) collect Inspire therapy clinical evidence in the clinical practice setting; 2) collect additional information on the effectiveness, use and safety in the commercial setting; and 3) engage physician customers to report the collective outcome within a group of properly trained programs that utilize Inspire therapy on a regular basis.

In addition, a sub-study will be conducted under this Registry at a limited number of Registry centers and will include a cohort of Registry patients and a cohort of patients who have not received the Inspire therapy device due to denial of insurance coverage. The two sub-study cohorts' quality of life and AHI data will be compared.

Conditions

Interventions

DEVICE

Inspire therapy

OTHER

No intervention

Sponsors & Collaborators

  • Inspire Medical Systems, Inc.

    lead INDUSTRY

Principal Investigators

  • Gwen Gimmestad · Inspire Medical Systems, Inc.

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-19
Primary Completion
2025-09-30
Completion
2025-12-31

Countries

  • United States
  • Belgium
  • Germany
  • Netherlands
  • Switzerland

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02907398 on ClinicalTrials.gov