Reducing Obstructive Sleep Apnea After Hypoglossal Nerve Stimulation Through Mandibular Advancement

NCT07132307 | Recruiting FDA Device

• 1 other identifier: 202504015
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Obstructive Sleep Apnea

Keywords

Otolaryngology; Mandibular advancement device; Hypoglossal nerve stimulation

Outcome Measures

Primary Outcomes (1)

• Proportion of responders

  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.

  through study completion on average 8 weeks

Secondary Outcomes (9)

• Magnitude of change in apnea-hypopnea index (AHI).

  through study completion on average 8 weeks

• Change in Oxygen desaturation index (ODI)

  through study completion on average 8 weeks

• Change in the time spent below oxygen saturation 90%

  through study completion on average 8 weeks

• Changes in the mean arterial oxygen saturation (SaO2)

  through study completion on average 8 weeks

• Adherence to MAD use

  through study completion on average 8 weeks

Study Arms (1)

Mandibular Advancement Device (MAD)

EXPERIMENTAL

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).

Device: Mandibular advancement device (MAD)

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.

Also known as: ProSomnus Sleep Device.

Mandibular Advancement Device (MAD)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

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MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Occlusal Splints

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Officials

• Jay Piccirillo, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jay F Piccirillo, MD

CONTACT

314-362-8641; piccirj@wustl.edu

Sara Kukuljan

CONTACT

314-362-7653; kukuljas@wustl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: no masking required
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Otolaryngology

Model Details: Pilot, single-intervention study

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: August 20, 2025
• Study Start: July 29, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)