Mandibular advancement to reduce sleep apnea after hypoglossal nerve stimulation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

ROHMA is a single-arm pilot intervention testing a mandibular advancement device (MAD) in adults with moderate to severe obstructive sleep apnea who have failed hypoglossal nerve stimulation (HGNS). Eligible participants are adults treated with HGNS at Washington University between April 4, 2019 and October 20, 2024 or previously enrolled in a specified prior protocol. The study will fit participants with a MAD, require avoidance of other OSA treatments during follow-up, and use home sleep apnea tests and safety/feasibility measures to track outcomes. The primary aims are to measure effectiveness in reducing apnea events and to document device tolerability and safety in this specific post-HGNS population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Washington University School of Medicine
  St Louis, Missouri, United States Recruiting

Study contacts

• Principal investigator: Jay Piccirillo, MD — Washington University School of Medicine
• Study coordinator: Jay F Piccirillo, MD
• Email: piccirj@wustl.edu
• Phone: 314-362-8641

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.