Reducing Obstructive Sleep Apnea After Hypoglossal Nerve Stimulation Through Mandibular Advancement

Recruiting now · Not applicable

Conditions studied: Obstructive Sleep Apnea

In brief

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).

Key facts

Study ID

NCT07132307

Run by

Washington University School of Medicine

People needed

30

Starts

2025-07-29

Expected to finish

2027-02-01

Last updated by the study team

2026-03-19

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Washington University School of Medicine — St Louis, Missouri, United States (enrolling)

Full record on ClinicalTrials.gov

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