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Completed

NCT Number: NCT06540716

Inspire Singapore Study

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

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases OSA Respiration Disorders Respiratory Tract Diseases Sleep Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National University Hospital, Singapore

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Inspire System

Device

Hypoglossal nerve stimulation therapy will be activated at approximately 1 month post-implant.

Primary outcomes

  1. Inspiratory Overlap

    Time frame: 0-3 months post-therapy activation

    Percentage (%) of inspiratory overlap as measured by polysomnography (PSG)

Secondary outcomes

  1. Therapy Effectiveness

    Time frame: 6 months post-therapy activation

    Change in Apnea-Hypopnea Index (AHI)

  2. Symptom Reduction

    Time frame: 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.

Other outcomes

  1. Rate of Adverse Events

    Time frame: 6 months post-therapy activation

    Report of procedure/device/therapy-related adverse events

  2. Therapy Adherence

    Time frame: 6 months post-therapy activation

    Mean therapy use (hours per day)

  3. Functional Outcomes of Sleep Questionnaire (FOSQ) Score

    Time frame: 6 months post-therapy activation

    Changes in Functional Outcomes of Sleep Questionnaire (FOSQ). Total score range 5-20, with higher scores indicating better functional status.

  4. Inspiratory Overlap

    Time frame: 6 months post-therapy activation

    Percentage (%) of inspiratory overlap as measured by polysomnography (PSG)

Sponsors and collaborators

Lead sponsor

Inspire Medical Systems, Inc.

Industry

Registry information

Official study title

Inspire Singapore Study: Confirmation of Therapy Performance

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 6, 2024
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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