Who is eligible for clinical trial NCT07132307?

Participants must meet protocol criteria for Obstructive Sleep Apnea. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT07132307 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-03-18

Reducing Obstructive Sleep Apnea After Hypoglossal Nerve Stimulation Through Mandibular Advancement (NCT07132307)

🟢 Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Washington University School of Medicine

🩺 Plain-English Summary (8th-Grade Level)

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).

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (12 items).

Location: Washington University School of Medicine — St Louis, Missouri

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.

Usually NOT eligible if any of the following apply:

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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Washington University School of Medicine — St Louis, Missouri

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗