Reducing Obstructive Sleep Apnea After Hypoglossal Nerve Stimulation Through Mandibular Advancement
NCT ID: NCT07132307
Last Updated: 2025-08-20
Study Results
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Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2025-07-29
2026-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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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).
Mandibular advancement device (MAD)
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.
Interventions
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Mandibular advancement device (MAD)
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
70 Years
ALL
No
Sponsors
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Washington University School of Medicine
OTHER
Responsible Party
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Jay F. Piccirillo, MD
Professor of Otolaryngology
Principal Investigators
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Jay Piccirillo, MD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Washington University School of Medicine
St Louis, Missouri, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
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202504015
Identifier Type: -
Identifier Source: org_study_id
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