Mandibular advancement to reduce sleep apnea after hypoglossal nerve stimulation
Reducing Obstructive Sleep Apnea After Hypoglossal Nerve Stimulation Through
This will try a mandibular advancement device (a mouthpiece worn at night) to see if it reduces moderate to severe obstructive sleep apnea in adults who cannot tolerate CPAP and whose hypoglossal nerve stimulation did not help enough.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Washington University School of Medicine Academic / other |
| Locations | 1 site (St Louis, Missouri) |
| Trial ID | NCT07132307 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18–70 who are CPAP-intolerant, meet the study's definition of HGNS failure, can insert and remove the MAD independently, have sufficient dentition for an oral appliance, can complete home sleep testing, and have internet access for study activities.
Not a fit: Patients over 70, those with insufficient healthy teeth for an oral appliance, prior intolerance to MAD therapy, chronic nasal obstruction, or other exclusionary conditions are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the mandibular device could offer a noninvasive option to reduce apnea events and improve sleep for patients who failed HGNS and cannot use CPAP.
How similar studies have performed: Mandibular advancement devices have proven effective for many people with OSA, but applying MADs specifically after failed hypoglossal nerve stimulation is a new, largely untested approach.
Eligibility criteria
Show full inclusion / exclusion 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. * 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 this trial is running
St Louis, Missouri
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.