NCT06540716

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 25, 2024

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 2, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 6, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 17, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

May 22, 2026

Status Verified

August 1, 2025

Enrollment Period

12 months

First QC Date

August 2, 2024

Last Update Submit

May 20, 2026

Conditions

Obstructive Sleep ApneaOSASleep Apnea

Outcome Measures

Primary Outcomes (1)

  • Inspiratory Overlap

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

    0-3 months post-therapy activation

Secondary Outcomes (2)

  • Therapy Effectiveness

    6 months post-therapy activation

  • Symptom Reduction

    6 months post-therapy activation

Other Outcomes (4)

  • Rate of Adverse Events

    6 months post-therapy activation

  • Therapy Adherence

    6 months post-therapy activation

  • Functional Outcomes of Sleep Questionnaire (FOSQ) Score

    6 months post-therapy activation

  • +1 more other outcomes

Study Arms (1)

Hypoglossal nerve stimulation

OTHER
Device: Inspire System

Interventions

Inspire SystemDEVICE

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

Hypoglossal nerve stimulation

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of moderate to severe OSA (AHI 15-65)
  • Failure of, or intolerance to CPAP

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National University Hospital

Singapore, Singapore

Location

Singapore General Hospital

Singapore, Singapore

Location

MeSH Terms

Conditions

Sleep Apnea, ObstructiveSleep Apnea Syndromes

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Toh Song Tar, MD

    Singapore General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2024

First Posted

August 6, 2024

Study Start

July 25, 2024

Primary Completion

July 17, 2025

Study Completion

December 1, 2025

Last Updated

May 22, 2026

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

IPD will not be shared.

Locations

SG(2)