NCT07132307 · Washington University School of Medicine
Reducing Obstructive Sleep Apnea After Hypoglossal Nerve Stimulation Through Mandibular Advancement
(ROHMA)
What this study is 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).
View original scientific description
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).
Interventions
DEVICE
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 measures
Proportion of responders
Time frame: through 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- St Louis, Missouri
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 19, 2026 · Source of record for eligibility and locations