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Study on Maxillomandibular Advancement Surgery for Obstructive Sleep Apnea

This study is looking at how well Maxillomandibular Advancement (MMA) surgery works for people with moderate to severe Obstructive Sleep Apnea (OSA). Researchers want to see if a special device called a Remote Controlled Mandibular Positioner (RCMP) can predict who will benefit most from MMA surgery. The RCMP device helps find the best jaw position to improve breathing during sleep. You might be able to join if you are 30-65 years old, have an AHI (Apnea-Hypopnea Index, a measure of sleep apnea severity) of 15 or more, and a BMI (Body Mass Index) between 25 and 34.9. The study aims to see if changes in your AHI after using the RCMP device can predict how much your AHI will improve after MMA surgery. The study is currently unclear about its recruitment status and plans to enroll 20 participants.

Study design
This is an interventional study, meaning participants will receive a specific intervention. It plans to enroll 20 participants.
What's involved
You would undergo a special sleep study using the RCMP device, followed by Maxillomandibular Advancement (MMA) surgery. Your AHI will be measured before surgery and again 6 months after surgery.
Compensation
Not stated in the trial record.
Follow-up
Your AHI will be measured 6 months after surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03929549

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

Recruiting
NAAges 30–65Interventional
University of Michigan
~20 participants
Updated 2024-12-09 on ClinicalTrials.gov
What's tested:RCMP titration

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary outcome variable: Change in AHI (pre-post) with MMA surgery
Measured over baseline (pre-operative), post surgery (6 months)
+1 more outcome measured

Conditions

Obstructive Sleep Apnea
Maxillomandibular Advancement Surgery

Explore related trials

Obstructive Sleep Apnea

Where it's being run

1 sites across 1 states
Michigan1

Study leadership

  • Sharon Aronovich, DMD · PRINCIPAL_INVESTIGATOR · University of Michigan

Who to contact

Jennifer Lay-Luskin
[email protected]
734-763-5963
Email the study team

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What this trial measures

  • Primary outcome variable: Change in AHI (pre-post) with MMA surgerybaseline (pre-operative), post surgery (6 months)

    Secondary outcome variable: Failure of MMA surgery defined as AHI ≥ 15/hour

  • Primary predictor variable: Change in AHI, from baseline to maximal therapeutic protrusion, with RCMP studybaseline (pre-operative), post surgery (6 months)

    age, sex, BMI, AHI, retrognathia, airway collapse on forced inspiration, AHI reduction on RCMP titration and magnitude of advancement.