Recruiting

Mandibular Advancement Devices

Sponsor:

Washington University School of Medicine

Code:

NCT07132307

Conditions

Obstructive Sleep Apnea

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Mandibular advancement device (MAD)

Study Details

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

Study ID

NCT07132307

Start date

Jul 29, 2025

Status verified date

Mar, 2026

Completion date

Feb 1, 2027

Anticipated

Primary completion date

Feb 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

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).

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Jay F Piccirillo, MD

314-362-8641piccirj@wustl.edu

Sara Kukuljan

314-362-7653kukuljas@wustl.edu

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Sara Kukuljan, BS, RN

314-362-7563kukuljans@ent.wustl.edu

More Information

Sponsor

Washington University School of Medicine

Last update posted

Mar 19, 2026

Last verified

Mar, 2026

Keywords

  • Otolaryngology
  • Mandibular advancement device
  • Hypoglossal nerve stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-03-19.