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โ† Trials
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Predicting Outcomes in Hypoglossal Nerve Stimulation Therapy With Stimulated Upper Airway Mechanics

Recruitingn/aAges 18 Years - anyAllJohns Hopkins University
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In plain words

What the trial is, and whether it could suit you

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. Inspireโ„ข 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 sle

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Male and female participants with moderate or severe sleep apnea (defined by \> 15 apneas and hypopneas per hour of sleep), who are undergoing DISE as part of routine evaluation for Inspire hypoglossal nerve stimulation therapy or for ineffective HGNS therapy. Exclusion Criteria: * Significant cardiac disease, unstable or recent cardiac events * Active pulmonary, liver or renal disease * Uncontrolled hypertension (BP\>160/100) * Neuromuscular disease * Major psychiatric disease * Pregnancy * Anticoagulation therapy (e.g. Coumadin, Dabigatran)
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What it tests

  • Not listed
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Where

1 site
Johns Hopkins Hospital
Baltimore, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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