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Predicting Outcomes in Hypoglossal Nerve Stimulation Therapy for Sleep Apnea

This observational study is looking at ways to better predict who will benefit from Inspire™ hypoglossal nerve stimulation (HGNS) therapy for obstructive sleep apnea (OSA). Inspire™ is an FDA-approved device for people with OSA who can't use CPAP. Currently, about one-third of patients don't respond well to HGNS. Researchers will measure airflow during a procedure called drug-induced sleep endoscopy (DISE) to see if it can help predict success. You may be able to join if you are an adult with moderate or severe sleep apnea and are having a DISE for HGNS evaluation or if your current HGNS therapy isn't working. The study aims to see if these airflow measurements can predict HGNS success one year after the device is implanted. The study status is unclear.

Study design
This is an observational study, meaning researchers will watch and record information without giving you a specific treatment. It plans to include 60 participants.
What's involved
Participants will have their tidal airflow measured during a drug-induced sleep endoscopy (DISE) procedure, which takes up to one hour. Success of HGNS therapy will be assessed one year after implantation.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for one year after HGNS implantation to assess therapy success.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05429983

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

Recruiting
Not specifiedAges 18+Observational
Johns Hopkins University
~60 participants
Updated 2025-12-24 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Tidal airflow with direct genioglossus stimulation
Measured over at the time of drug-induced sleep endoscopy, up to 1 hour
+1 more outcome measured

Conditions

Sleep Apnea, Obstructive

Explore related trials

Obstructive Sleep Apnea

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Kevin Motz, MD · PRINCIPAL_INVESTIGATOR · Johns Hopkins University

Who to contact

Kevin M Motz
[email protected]
410614245
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Eligibility criteria

Inclusion

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

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)

What this trial measures

  • Tidal airflow with direct genioglossus stimulationat 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 indexat 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).