Inspire Singapore Study

Inspire Singapore Study: Confirmation of Therapy Performance

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

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea; Sleep Apnea; OSA
• Intervention / Treatment: Device: Inspire System

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 Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore
    • National University Hospital
  • Singapore, Singapore
    • Singapore General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Main 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Hypoglossal nerve stimulation	Device: Inspire System; Hypoglossal nerve stimulation therapy will be activated at approximately 1 month post-implant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inspiratory Overlap	Percentage (%) of inspiratory overlap as measured by polysomnography (PSG)	0-3 months post-therapy activation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Therapy Effectiveness	Change in Apnea-Hypopnea Index (AHI)	6 months post-therapy activation
Symptom Reduction	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.	6 months post-therapy activation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Adverse Events	Report of procedure/device/therapy-related adverse events	6 months post-therapy activation
Therapy Adherence	Mean therapy use (hours per day)	6 months post-therapy activation
Inspiratory Overlap	Percentage (%) of inspiratory overlap as measured by polysomnography (PSG)	6 months post-therapy activation
Functional Outcomes of Sleep Questionnaire (FOSQ) Score	Changes in Functional Outcomes of Sleep Questionnaire (FOSQ). Total score range 5-20, with higher scores indicating better functional status.	6 months post-therapy activation

Collaborators and Investigators

• Sponsor: Inspire Medical Systems, Inc.
• Investigators: Principal Investigator: Toh Song Tar, MD, Singapore General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2024
• Primary Completion (Actual): July 17, 2025
• Study Completion (Actual): December 1, 2025

Study Registration Dates

• First Submitted: August 2, 2024
• First Submitted That Met QC Criteria: August 2, 2024
• First Posted (Actual): August 6, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: 2022-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes