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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
Sponsor:
Collaborator:
American Academy of Sleep Medicine
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:

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

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Group/Cohort
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 Measures :
  1. 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.

  2. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Participants will be those undergoing drug-induced sleep endoscopy as part of routine clinical care for work up hypoglossal nerve stimulation therapy candidacy. All participants will have a confirmed diagnosis of obstructive sleep apnea with an apnea-hypopnea index >15 and deemed to be intolerant of continuous positive airway pressure.
Criteria

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)

Information from the National Library of Medicine

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


Contacts
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Contact: Kevin M Motz 410614245 kmotz1@jh.edu

Sponsors and Collaborators
Johns Hopkins University
American Academy of Sleep Medicine
Investigators
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Principal Investigator: Kevin Motz, MD Johns Hopkins University
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT05429983    
Other Study ID Numbers: IRB00319723
278-jf-22 ( Other Grant/Funding Number: American Academy of Sleep Medicine )
First Posted: June 24, 2022    Key Record Dates
Last Update Posted: June 24, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases