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

NCT05429983 | Recruiting

• 2 other identifiers: IRB00319723278-jf-22
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea, Obstructive

Outcome Measures

Primary Outcomes (2)

• Tidal airflow with direct genioglossus stimulation

  Tidal airflow (mL) with direct stimulation of the genioglossus muscle will be measured at the time of drug-induced sleep endoscopy.

  at the time of drug-induced sleep endoscopy, up to 1 hour

• HGNS therapy success as assessed by the apnea hypopnea index

  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).

  at 1 year post HGNS implantation

Secondary Outcomes (2)

• Therapeutic CPAP pressure with direct genioglossus stimulation

  At the time of drug-induced sleep endoscopy, up to 1 hour

• Airway critical closing pressure with direct genioglossus stimulation

  At the time of drug-induced sleep endoscopy, up to 1 hour

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Johns Hopkins University: lead
• American Academy of Sleep Medicine: collaborator

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Kevin Motz, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kevin M Motz

CONTACT

410614245; kmotz1@jh.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2022
• First Posted: June 24, 2022
• Study Start: November 29, 2022
• Primary Completion (Estimated): November 29, 2027
• Study Completion (Estimated): November 29, 2028
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)