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Reducing Obstructive Sleep Apnea After Hypoglossal Nerve Stimulation Through Mandibular Advancement

Recruiting

Reducing Obstructive Sleep Apnea After Hypoglossal Nerve Stimulation Through

Who can join

Ages 18 to 70 · All sexes

Full eligibility criteria
Inclusion Criteria:

* Age ≥ 18 years.
* Ability to read, write, speak, and understand English.
* Failure of hypoglossal nerve stimulation (HGNS) therapy, defined as intolerance to HGNS or insufficient AHI reduction based on modified Sher criteria while using HGNS.
* Ability to insert and remove the mandibular advancement device (MAD) independently.
* Ability to complete all study assessments and evaluations, including home sleep apnea tests (HSAT).
* Ability to abstain from any other treatment for obstructive sleep apnea (OSA) during the entire study duration.
* Access to an internet-connected device (phone, tablet, or laptop) with a camera.

Exclusion Criteria:

* Age over 70 years.
* Inability to use a mandibular advancement device (MAD), defined as having fewer than 9 healthy teeth per dental arch.
* Prior intolerance to MAD therapy.
* Previous participation in a trial involving the use of oral appliances.
* Chronic nasal obstruction.
* Dependence on or frequent use of medications that alter consciousness, respiration, or alertness.
* Insomnia and/or use of medications to treat insomnia.
* Sleep disorders such as narcolepsy, insomnia, restless leg syndrome, or other disorders affecting sleep, and/or use of medications to treat such disorders.
* Substance abuse.
* Unstable psychiatric disorders.
* Current use of a GLP-1 receptor agonist (e.g., Zepbound, Wegovy, Ozempic, Mounjaro) with ongoing, active weight loss at the time of enrollment, or recent dose escalation within the prior 8 weeks.

About the study

The purpose of this study is to evaluate the effectiveness, feasibility, and safety of mandibular advancement devices (MAD) for treating severe obstructive sleep apnea (OSA) in patients who are CPAP intolerant and have failed hypoglossal nerve stimulation (HGNS).

What is being tested

Sponsor: Washington University School of Medicine · Participants: 30 · Started: Jul 29, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07132307

Locations in the U.S.

MissouriWashington University School of Medicine, St Louis

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.