Inspire Singapore Study

Last updated: August 15, 2024
Sponsor: Inspire Medical Systems, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sleep Apnea Syndromes

Sleep Disorders

Treatment

Inspire System

Clinical Study ID

NCT06540716
2022-001
  • Ages > 21
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Main Inclusion Criteria:

  • Diagnosis of moderate to severe OSA (AHI 15-65)

  • Failure of, or intolerance to CPAP

Exclusion

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.

Study Design

Total Participants: 44
Treatment Group(s): 1
Primary Treatment: Inspire System
Phase:
Study Start date:
August 01, 2024
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • National University Hospital

    Singapore,
    Singapore

    Active - Recruiting

  • Singapore General Hospital

    Singapore,
    Singapore

    Active - Recruiting

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