Reducing Obstructive Sleep Apnea After Hypoglossal Nerve Stimulation Through Mandibular Advancement
Reducing Obstructive Sleep Apnea After Hypoglossal Nerve Stimulation Through
Washington University School of Medicine
30 participants
Jul 29, 2025
INTERVENTIONAL
Conditions
Summary
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).
Eligibility
Inclusion Criteria7
- 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 Criteria11
- 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.
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Interventions
The intervention in this study involves fitting and using a mandibular advancement device (MAD), specifically the ProSomnus Sleep Device, to treat moderate to severe obstructive sleep apnea (OSA) in patients who are intolerant to CPAP and have failed hypoglossal nerve stimulation (HGNS) therapy.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07132307