BridgeMD
New treatment option for Obstructive Sleep Apnea
Official title Reducing Obstructive Sleep Apnea After Hypoglossal Nerve Stimulation Through Mandibular Advancement
ClinicalTrials.gov ID: NCT07132307
What this study is testing
- What it's testing
- 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).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join 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...
- 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).
You likely can't join 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- St Louis, Missouri, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include St Louis, Missouri, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.