Reducing Obstructive Sleep Apnea After Hypoglossal Nerve Stimulation Through Mandibular Advancement

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT07132307
Status
Recruiting
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Conditions

  • Obstructive Sleep Apnea

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Mandibular advancement device (MAD) — DEVICE
    The intervention in this study involves fitting and using a mandibular advancement device (MAD), specifically the ProSomnus Sleep Device, to treat moderate to severe obstructive sleep apnea (OSA) in patients who are intolerant to CPAP and have failed hypoglossal nerve stimulation (HGNS) therapy.

Study Details

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).

Key Dates

Start date
Jul 29, 2025
Status verified
Mar 2026
Primary completion
Feb 1, 2027
Completion
Feb 1, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • 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).

Primary Outcome Measure

Proportion of responders [ Time Frame: through study completion on average 8 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
Sara Kukuljan, BS, RN
[email protected]
314-362-7563

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By research site
Washington University School of Medicine· St Louis, MO

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