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).
Detailed 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 Criteria
Age Range: 18 years to 70 years
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.
* Current use of a GLP-1 receptor agonist (e.g., Zepbound, Wegovy, Ozempic, Mounjaro) with ongoing, active weight loss at the time of enrollment, or recent dose escalation within the prior 8 weeks.