Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
NCT07132307

Reducing Obstructive Sleep Apnea After Hypoglossal Nerve Stimulation Through Mandibular Advancement

Led by Washington University School of Medicine · Updated on 2026-03-19

30

Participants Needed

1

Research Sites

78 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

Reducing Obstructive Sleep Apnea After Hypoglossal Nerve Stimulation Through Mandibular Advancement

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Ability to read, write, speak, and understand English
  • Failure of hypoglossal nerve stimulation (HGNS) therapy due to intolerance or insufficient apnea-hypopnea index (AHI) reduction
  • Ability to independently insert and remove the mandibular advancement device (MAD)
  • Ability to complete all study assessments, including home sleep apnea tests (HSAT)
  • Ability to abstain from other obstructive sleep apnea treatments during the study
  • Access to an internet-connected device with a camera (phone, tablet, or laptop)
Not Eligible

You will not qualify if you...

  • Age over 70 years
  • Inability to use a mandibular advancement device due to fewer than 9 healthy teeth per dental arch
  • Prior intolerance to mandibular advancement device therapy
  • Previous participation in a trial involving oral appliances
  • Chronic nasal obstruction
  • Dependence on or frequent use of medications affecting consciousness, respiration, or alertness
  • Insomnia or use of medications to treat insomnia
  • Sleep disorders such as narcolepsy, restless leg syndrome, or other disorders affecting sleep, or use of medications for these disorders
  • Substance abuse
  • Unstable psychiatric disorders
  • Current use of GLP-1 receptor agonists with active weight loss or recent dose increases within 8 weeks

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Washington University School of Medicine

St Louis, Missouri, United States, 63110

Actively Recruiting

Loading map...

Research Team

J

Jay F Piccirillo, MD

CONTACT

S

Sara Kukuljan

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here