Predicting Outcomes in Hypoglossal Nerve Stimulation Therapy With Stimulated Upper Airway Mechanics
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|ClinicalTrials.gov Identifier: NCT05429983|
Recruitment Status : Not yet recruiting
First Posted : June 24, 2022
Last Update Posted : June 24, 2022
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.
|Condition or disease|
|Sleep Apnea, Obstructive|
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||Assessing Stimulated Upper Airway Mechanics to Predict Outcomes in Hypoglossal Nerve|
|Estimated Study Start Date :||September 2022|
|Estimated Primary Completion Date :||September 2024|
|Estimated Study Completion Date :||September 2025|
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.
- Tidal airflow with direct genioglossus stimulation [ Time Frame: at the time of drug-induced sleep endoscopy, up to 1 hour ]Tidal airflow (mL) with direct stimulation of the genioglossus muscle will be measured at the time of drug-induced sleep endoscopy.
- HGNS therapy success as assessed by the apnea hypopnea index [ Time Frame: at 1 year post HGNS implantation ]Successful treatment with HGNS, as defined by a 50% reduction in apnea hypopnea index (AHI) and an on-therapy AHI of <15 (the same criteria as in major trials of non-CPAP OSA treatment).
- Therapeutic CPAP pressure with direct genioglossus stimulation [ Time Frame: At the time of drug-induced sleep endoscopy, up to 1 hour ]Therapeutic CPAP pressure (cmH20) with direct stimulation of the genioglossus muscle will be measured at the time of drug-induced sleep endoscopy.
- Airway critical closing pressure with direct genioglossus stimulation [ Time Frame: At the time of drug-induced sleep endoscopy, up to 1 hour ]Airway critical closing pressure (cmH20) with direct stimulation of the genioglossus muscle will be measured at the time of drug-induced sleep endoscopy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05429983
|Contact: Kevin M Motzemail@example.com|
|Principal Investigator:||Kevin Motz, MD||Johns Hopkins University|