Inspire Singapore Study

Not Applicable

Recruiting

• Conditions: OSA; Obstructive Sleep Apnea; Sleep Apnea
• Interventions: Device: Inspire System

• Registration Number: NCT06540716
• Lead Sponsor: Inspire Medical Systems, Inc.

Brief 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.

Study Timeline

• Status Verified: 2024-08
• Study Start: 2024-08
• Study First Submitted: 2024-08-02
• Study First Submitted QC: 2024-08-02
• Study First Posted: 2024-08-06
• Last Update Submitted: 2024-08-15
• Last Update Posted: 2024-08-19
• Primary Completion: 2025-08
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 44

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hypoglossal nerve stimulation	Inspire System	-

Primary Outcome Measures

Name	Time	Method
Inspiratory Overlap	0-3 months post-therapy activation	Percentage (%) of inspiratory overlap as measured by polysomnography (PSG)

Secondary Outcome Measures

Name	Time	Method
Therapy Effectiveness	6 months post-therapy activation	Change in Apnea-Hypopnea Index (AHI)
Symptom Reduction	6 months post-therapy activation	Mean Epworth Sleepiness Scale (ESS) Score of less than 10. ESS scores range from 0-24 with a score of less than 10 indicating normalized daytime sleepiness.

Trial Locations

Locations (2)

Singapore General Hospital; 🇸🇬 Singapore, Singapore

National University Hospital; 🇸🇬 Singapore, Singapore