Reducing Obstructive Sleep Apnea After Hypoglossal Nerve Stimulation Through Mandibular Advancement
Purpose
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).
Condition
- Obstructive Sleep Apnea
Eligibility
- Eligible Ages
- Between 18 Years and 70 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- Pilot, single-intervention study
- Primary Purpose
- Other
- Masking
- None (Open Label)
- Masking Description
- no masking required
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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). |
|
Recruiting Locations
Washington University in St. Louis and nearby locations
Washington University School of Medicine
St Louis 4407066, Missouri 4398678 63110
St Louis 4407066, Missouri 4398678 63110
More Details
- NCT ID
- NCT07132307
- Status
- Recruiting
- Sponsor
- Washington University School of Medicine
Detailed 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.