Predicting Outcomes in Hypoglossal Nerve Stimulation Therapy With Stimulated Upper Airway Mechanics

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT05429983
Status
Recruiting
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Conditions

  • Sleep Apnea, Obstructive

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

Obstructive sleep apnea (OSA) is a highly prevalent disease resulting from dynamic upper airway collapse during sleep. Continuous positive airway pressure (CPAP) is highly efficacious but high rates of non-adherence to CPAP leaves large number of OSA patients at risk for cardiometabolic sequelae. Inspire™ is an FDA-approved hypoglossal nerve stimulation device (HGNS) used in select patients with OSA who are intolerant of CPAP. The device consists of an implanted impulse generator with a stimulating cuff lead around the distal hypoglossal nerve. Despite these stringent selection criteria, up to one-third of patients implanted have inadequate responses to HGNS and remain at risk for complications from untreated OSA. The current proposal builds on routine clinical care to characterize upper airway biomechanics and determine predictors of clinical responses to HGNS therapy. Drug induced sleep endoscopy (DISE) is a prerequisite for HGNS treatment and represents an ideal opportunity to rapidly characterize upper airway dynamics under controlled, standardized conditions. The amount of nasal pressure required to relieve airway obstruction (minimal therapeutic pressure) is a significant predictor of successful treatment of OSA with HGNS. As a result, CPAP titration (measuring pharyngeal collapse patterns at varying nasal pressures) has become an integral part of DISE to select parties for HGNS at multiple institutions. Nevertheless, changes in upper airway collapsibility in response HGNS may differ significantly between patients. This stud will examine if changes in upper airway patency with direct genioglossus muscle stimulation at the time of DISE predicts successful treatment with HGNS as defined by a 50% reduction on apnea-hypopnea index (AHI) and an on-treatment AHI \<20.

Key Dates

Start date
Nov 29, 2022
Status verified
Dec 2025
Primary completion
Nov 29, 2027
Completion
Nov 29, 2028

Study Design

Enrollment
60 participants (estimated)

Arms

  • Arm: Hypoglossal Nerve Stimulation Candidates
    Participants will have a diagnosis of obstructive sleep apnea and have failed treatment with continuous positive airway pressure (CPAP). Participants will be those undergoing drug-induced sleep endoscopy (DISE) as part of routine clinical care for work up of hypoglossal nerve stimulation candidacy as a treatment for obstructive sleep apnea.

Primary Outcome Measure

Tidal airflow with direct genioglossus stimulation [ Time Frame: at the time of drug-induced sleep endoscopy, up to 1 hour ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins HospitalBaltimoreMaryland21287
Kevin M Motz, MD
[email protected]
301-992-1779

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By research site
Johns Hopkins Hospital· Baltimore, MD

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