RECRUITING

Reducing Obstructive Sleep Apnea After Hypoglossal Nerve Stimulation Through Mandibular Advancement

Description

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

Obstructive Sleep Apnea
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Related Conditions:

Obstructive Sleep Apnea

Study Overview

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Study Details

Study overview

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).

Reducing Obstructive Sleep Apnea After Hypoglossal Nerve Stimulation Through

Reducing Obstructive Sleep Apnea After Hypoglossal Nerve Stimulation Through Mandibular Advancement

Condition
Obstructive Sleep Apnea
Intervention / Treatment

-

Contacts and Locations

Saint Louis

Washington University School of Medicine, Saint Louis, Missouri, United States, 63110

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Washington University School of Medicine,

Jay Piccirillo, MD, PRINCIPAL_INVESTIGATOR, Washington University School of Medicine

Study Record Dates

2026-03-01