Reducing Obstructive Sleep Apnea After Hypoglossal Nerve Stimulation Through Mandibular Advancement (ROHMA)

The Washington University

Status: Enrolling

Conditions: Obstructive Sleep Apnea

Treatments: Device: Mandibular advancement device (MAD)

Study type: Interventional

Funder types: Other

Identifiers

NCT07132307

202504015

Details and patient eligibility

About

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).

Full description

ROHMA is a pilot/single intervention study aiming to evaluate effectiveness of a mandibular advancement device (MAD) for treating moderate to severe obstructive sleep apnea (OSA) in patients who have failed hypoglossal nerve stimulation therapy (HGNS). Individuals who received a HGNS therapy at Washington University from April 4 2019 to October 20 2024, or were enrolled in a prior study (HRPO #: 202309014) will be recruited for the study.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 1 patient group

Mandibular Advancement Device (MAD)

Experimental group

Description:

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).

Treatment:

Device: Mandibular advancement device (MAD)