Reducing Obstructive Sleep Apnea After Hypoglossal Nerve Stimulation Through

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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.

Locations
United States
Missouri
Washington University School of Medicine
RECRUITING
St Louis
Contact Information
Primary
Jay F Piccirillo, MD
piccirj@wustl.edu
314-362-8641
Backup
Sara Kukuljan
kukuljas@wustl.edu
314-362-7653
Time Frame
Start Date: 2025-07-29
Estimated Completion Date: 2026-03-01
Participants
Target number of participants: 30
Treatments
Experimental: Mandibular Advancement Device (MAD)
This study is experimental. It involves a single-intervention design where participants who have failed hypoglossal nerve stimulation (HGNS) therapy for moderate to severe obstructive sleep apnea (OSA) will be treated with a mandibular advancement device (MAD).
Related Therapeutic Areas
Sponsors
Leads: Washington University School of Medicine

This content was sourced from clinicaltrials.gov