Reducing Obstructive Sleep Apnea After Hypoglossal Nerve Stimulation Through
Washington University School of Medicine
Summary
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).
Description
ROHMA is a pilot/single intervention study aiming to evaluate effectiveness of a mandibular advancement device (MAD) for treating moderate to severe obstructive sleep apnea (OSA) in patients who have failed hypoglossal nerve stimulation therapy (HGNS). Individuals who received a HGNS therapy at Washington University from April 4 2019 to October 20 2024, or were enrolled in a prior study (HRPO #: 202309014) will be recruited for the study.
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
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-connecte…
Interventions
- DeviceMandibular advancement device (MAD)
The intervention in this study involves fitting and using a mandibular advancement device (MAD), specifically the ProSomnus Sleep Device, to treat moderate to severe obstructive sleep apnea (OSA) in patients who are intolerant to CPAP and have failed hypoglossal nerve stimulation (HGNS) therapy.
Location
- Washington University School of MedicineSt Louis, Missouri