Reducing Obstructive Sleep Apnea After Hypoglossal Nerve Stimulation Through Mandibular Advancement

Launched by WASHINGTON UNIVERSITY SCHOOL OF MEDICINE · Aug 18, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to help people with severe obstructive sleep apnea (OSA) who have not had success with two common treatments: CPAP machines and hypoglossal nerve stimulation (HGNS). The study is testing whether a mouthpiece called a mandibular advancement device (MAD), which gently moves the lower jaw forward to keep the airway open during sleep, can be a safe and effective option for these patients.

Adults 18 to 70 years old who speak English, have tried and not benefited from HGNS, and can use the mouthpiece on their own may be eligible to join. Participants will need to avoid other sleep apnea treatments during the study and complete sleep tests at home. They should also have enough healthy teeth to support the mouthpiece and access to a device with internet and a camera for study check-ins. This study is currently recruiting people who want to help find new ways to manage severe sleep apnea when other treatments haven’t worked.

Gender

ALL

Eligibility criteria

• Inclusion 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.
• Exclusion Criteria:
• • 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.