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RecruitingObstructive Sleep Apnea

Reducing Obstructive Sleep Apnea After Hypoglossal Nerve Stimulation Through Mandibular Advancement

Eligible age

18–70 yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

No

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About this 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).

Sponsor: Washington University School of Medicine

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.

Where it's recruiting

Missouri

St Louis

Source: ClinicalTrials.gov · NCT07132307 · last updated 2026-03-19