Inspire Singapore Study

Inspire Medical Systems

Status: Enrolling

Conditions: Sleep Apnea; OSA; Obstructive Sleep Apnea

Treatments: Device: Inspire System

Study type: Interventional

Funder types: Industry

Identifiers

NCT06540716

2022-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 44 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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44 participants in 1 patient group

Hypoglossal nerve stimulation

Other group

Treatment:

Device: Inspire System