NCT07132307 Reducing Obstructive Sleep Apnea After Hypoglossal Nerve Stimulation Through Mandibular Advancement
| NCT ID | NCT07132307 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Washington University School of Medicine |
| Condition | Obstructive Sleep Apnea |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-07-29 |
| Primary Completion | 2027-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2025-07-29 with a primary completion date of 2027-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
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. * 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.
Contact & Investigator
Jay Piccirillo, MD
PRINCIPAL INVESTIGATOR
Washington University School of Medicine
Frequently Asked Questions
Who can join the NCT07132307 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Obstructive Sleep Apnea. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07132307 currently recruiting?
Yes, NCT07132307 is actively recruiting participants. Contact the research team at piccirj@wustl.edu for enrollment information.
Where is the NCT07132307 trial being conducted?
This trial is being conducted at St Louis, United States.
Who is sponsoring the NCT07132307 clinical trial?
NCT07132307 is sponsored by Washington University School of Medicine. The principal investigator is Jay Piccirillo, MD at Washington University School of Medicine. The trial plans to enroll 30 participants.