Clinical trial NCT05429983: Predicting Outcomes in Hypoglossal Nerve Stimulation Therapy With Stimulated Upper Airway Mechanics
Official title: Assessing Stimulated Upper Airway Mechanics to Predict Outcomes in Hypoglossal Nerve
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sleep Apnea, Obstructive
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: American Academy of Sleep Medicine
First posted: 2022-06-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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)

Primary outcomes:
measure: Tidal airflow with direct genioglossus stimulation
timeFrame: at the time of drug-induced sleep endoscopy, up to 1 hour
measure: HGNS therapy success as assessed by the apnea hypopnea index
timeFrame: at 1 year post HGNS implantation
Secondary outcomes:
measure: Therapeutic CPAP pressure with direct genioglossus stimulation
timeFrame: At the time of drug-induced sleep endoscopy, up to 1 hour
measure: Airway critical closing pressure with direct genioglossus stimulation
timeFrame: At the time of drug-induced sleep endoscopy, up to 1 hour
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Kevin Motz, MD
role: PRINCIPAL_INVESTIGATOR
References: