Inspire Singapore Study

NCT ID: NCT06540716

Last Updated: 2024-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-31

Study Completion Date

2025-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Obstructive Sleep Apnea OSA Sleep Apnea

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hypoglossal nerve stimulation

Group Type OTHER

Inspire System

Intervention Type DEVICE

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

Interventions

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Inspire System

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

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.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Inspire Medical Systems, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Toh Song Tar, MD

Role: PRINCIPAL_INVESTIGATOR

Singapore General Hospital

Locations

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National University Hospital

Singapore, , Singapore

Site Status RECRUITING

Singapore General Hospital

Singapore, , Singapore

Site Status RECRUITING

Countries

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Singapore

Central Contacts

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Gwen Gimmestad

Role: CONTACT

763-392-9966

Mike Swierzewski

Role: CONTACT

Facility Contacts

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Siew Chen Ling

Role: primary

Corrina Kee Pei Yin

Role: primary

Other Identifiers

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2022-001

Identifier Type: -

Identifier Source: org_study_id

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