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Preliminary Evaluation of a RCMP to Predict Failure of Maxillomandibular Advancement Surgery for OSA

RecruitingNAAges 30 Years - 65 YearsAllUniversity of Michigan
NCT03929549 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Maxillomandibular advancement (MMA) surgery, one of the most successful surgical procedures for the treatment of obstructive sleep apnea (OSA), is predominantly used to manage patients with moderate to severe OSA. However, limiting factors include incomplete response in some cases, unfavorable facial changes as a result of large advancements, and risk of malocclusion or malunion. This study will be done to determine predictors of success with MMA surgery in patients with moderate to severe OSA. Studies have already shown the value of a remote controlled mandibular positioner (RCMP) device to identify the correct level of therapeutic protrusion needed with oral appliance therapy. Moreover, some patients experience a dose dependent improvement in sleep parameters based on the degree of protrusion during the titration study. Use of RCMP as a means to identify potential candidates for MMA,

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📋 Eligibility rules (as published)
Inclusion Criteria: AHI ≥ 15/hour 30-65 years of age BMI 25-34.9 Ideal operative candidate Unable or unwilling to use PAP Exclusion Criteria: BMI ≥ 35 younger than 30 or older than 65 years of age pregnancy Central sleep apnea (CSA) on baseline polysomnogram Chronic opioid use Active TMJ Disorders Inability to protrude the mandible beyond 5 mm Inability to follow-up after surgery Dental disorders including loose teeth or advanced periodontal disease
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What it tests

  • RCMP titration
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Where

1 site
Michigan Medicine Oral and Maxillofacial Surgery
Ann Arbor, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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