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Surgery

RCMP Prediction for Sleep Apnea Surgery Success

N/A
Recruiting
Led By Sharon Aronovich, DMD
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Unable or unwilling to use PAP
Ideal operative candidate
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (pre-operative), post surgery (6 months)
Awards & highlights

Study Summary

This trial will study the use of a remote controlled mandibular positioner (RCMP) to help predict success with maxillomandibular advancement (MMA) surgery in patients with moderate to severe obstructive sleep apnea (OSA).

Who is the study for?
This trial is for people aged 30-65 with moderate to severe obstructive sleep apnea (OSA), who have an AHI of at least 15/hour and a BMI between 25-34.9. They should be good candidates for surgery but unable or unwilling to use PAP therapy. Those with a high BMI, central sleep apnea, opioid use, TMJ disorders, dental issues, pregnancy, or inability to follow-up post-surgery are excluded.Check my eligibility
What is being tested?
The study tests if a remote controlled mandibular positioner (RCMP) can predict the success of maxillomandibular advancement (MMA) surgery in treating OSA. It aims to see if RCMP titration helps customize treatment by determining the necessary degree of jaw protrusion before surgery.See study design
What are the potential side effects?
While not directly related to side effects from RCMP titration itself, MMA surgery may lead to incomplete response in some patients, potential unfavorable facial changes due to large advancements and risks like malocclusion or malunion.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I cannot or do not want to use a PAP machine.
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I am considered a good candidate for surgery.
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I am between 30 and 65 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (pre-operative), post surgery (6 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (pre-operative), post surgery (6 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary predictor variable: Change in AHI, from baseline to maximal therapeutic protrusion, with RCMP study
variable: Change in AHI (pre-post) with MMA surgery

Trial Design

1Treatment groups
Experimental Treatment
Group I: RCMP titrationExperimental Treatment1 Intervention
Remotely Controlled Mandibular Positioner

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,787 Previous Clinical Trials
6,365,514 Total Patients Enrolled
Sharon Aronovich, DMD3.813 ReviewsPrincipal Investigator - University of Michigan
University of Michigan
1Patient Review
Dr. Aronovich was unprofessional, dismissive, and rude. He spoke over us, interrupted my daughter repeatedly, and insinuated that she was lying about her pain. He did not listen to our concerns or questions, and spent less than fifteen minutes with us before making his judgement. We had been hoping for answers and a path to resolving my daughter's chronic pain, but Dr. Aronovich offered us none of that. We left feeling frustrated, helpless, and unheard.

Media Library

Maxillomandibular Advancement Surgery (Surgery) Clinical Trial Eligibility Overview. Trial Name: NCT03929549 — N/A
Obstructive Sleep Apnea Research Study Groups: RCMP titration
Obstructive Sleep Apnea Clinical Trial 2023: Maxillomandibular Advancement Surgery Highlights & Side Effects. Trial Name: NCT03929549 — N/A
Maxillomandibular Advancement Surgery (Surgery) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03929549 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current quota for participants in this experiment?

"Affirmative. The information on clinicaltrials.gov affirms that this medical experiment is actively seeking volunteers and has been since it was first posted in August 2019. Currently, 20 patients are needed to be recruited from a single research centre."

Answered by AI

Are there any current openings for participants in this investigation?

"Per the data on clinicaltrials.gov, enrollment for this trial is still open; it was initially published on August 12th 2019 and most recently updated October 11th 2022."

Answered by AI
~6 spots leftby Dec 2025