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Mandibular Advancement for Obstructive Sleep Apnea After Failed Hypoglossal Nerve Stimulation

This study is looking at how well a device called a mandibular advancement device (MAD), specifically the ProSomnus Sleep Device, works for people with moderate to severe obstructive sleep apnea (OSA). This is for individuals who haven't found relief with CPAP (continuous positive airway pressure) and whose hypoglossal nerve stimulation (HGNS) therapy has not been successful. The study aims to see if the MAD can effectively treat OSA in these patients. You might be able to join if you are 18 or older, can speak English, and have failed HGNS therapy. Success in this study will be measured by the proportion of participants who respond to the treatment, typically over about 8 weeks. The current recruitment status is unclear.

Study design
This is a pilot study involving 30 participants. It is a single-intervention study, meaning all participants will receive the mandibular advancement device.
What's involved
The intervention involves fitting and using a mandibular advancement device. Participants must be able to insert and remove the device independently.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome will be measured through study completion, on average 8 weeks after starting the intervention.

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NCT07132307

Reducing Obstructive Sleep Apnea After Hypoglossal Nerve Stimulation Through Mandibular Advancement

Recruiting
NAAges 18–70Interventional
Washington University School of Medicine
~30 participants
Updated 2026-03-19 on ClinicalTrials.gov
What's tested:Mandibular advancement device (MAD)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of responders
Measured over through study completion on average 8 weeks

Conditions

Obstructive Sleep Apnea

Explore related trials

Obstructive Sleep Apnea

Where it's being run

1 sites across 1 states
Missouri1

Study leadership

  • Jay Piccirillo, MD · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine

Who to contact

Jay F Piccirillo, MD
[email protected]
314-362-8641
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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Proportion of respondersthrough study completion on average 8 weeks

    The proportion of responders will be defined as number of participants with more than a 50% reduction in apnea-hypopnea index (AHI) and a final AHI less than 15 (modified Sher criteria) after treatment compared to baseline, divided by the total number of participants treated with mandibular advancement device. The AHI is a standardized index used to diagnose and determine the severity of sleep apnea. AHI will be obtained from a home sleep apnea test completed by the participants and reviewed by a trained sleep neurologist.