RECRUITING

Reducing Obstructive Sleep Apnea After Hypoglossal Nerve Stimulation Through Mandibular Advancement

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Conditions

Obstructive Sleep ApneaOtolaryngologyMandibular advancement deviceHypoglossal nerve stimulation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

Reducing Obstructive Sleep Apnea After Hypoglossal Nerve Stimulation Through

Quick Facts

Study Start:2025-07-29
Study Completion:2026-03-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07132307

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.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥ 18 years.
  2. * Ability to read, write, speak, and understand English.
  3. * Failure of hypoglossal nerve stimulation (HGNS) therapy, defined as intolerance to HGNS or insufficient AHI reduction based on modified Sher criteria while using HGNS.
  4. * Ability to insert and remove the mandibular advancement device (MAD) independently.
  5. * Ability to complete all study assessments and evaluations, including home sleep apnea tests (HSAT).
  6. * Ability to abstain from any other treatment for obstructive sleep apnea (OSA) during the entire study duration.
  7. * Access to an internet-connected device (phone, tablet, or laptop) with a camera.
  1. * Age over 70 years.
  2. * Inability to use a mandibular advancement device (MAD), defined as having fewer than 9 healthy teeth per dental arch.
  3. * Prior intolerance to MAD therapy.
  4. * Previous participation in a trial involving the use of oral appliances.
  5. * Chronic nasal obstruction.
  6. * Dependence on or frequent use of medications that alter consciousness, respiration, or alertness.
  7. * Insomnia and/or use of medications to treat insomnia.
  8. * Sleep disorders such as narcolepsy, insomnia, restless leg syndrome, or other disorders affecting sleep, and/or use of medications to treat such disorders.
  9. * Substance abuse.
  10. * Unstable psychiatric disorders.

Contacts and Locations

Study Contact

Jay F Piccirillo, MD
CONTACT
314-362-8641
piccirj@wustl.edu
Sara Kukuljan
CONTACT
314-362-7653
kukuljas@wustl.edu

Principal Investigator

Jay Piccirillo, MD
PRINCIPAL_INVESTIGATOR
Washington University School of Medicine

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Washington University School of Medicine

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-29
Study Completion Date2026-03-01

Study Record Updates

Study Start Date2025-07-29
Study Completion Date2026-03-01

Terms related to this study

Keywords Provided by Researchers

  • Otolaryngology
  • Mandibular advancement device
  • Hypoglossal nerve stimulation

Additional Relevant MeSH Terms

  • Obstructive Sleep Apnea