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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 belowSelect...
I cannot or do not want to use a PAP machine.
Select...
I am considered a good candidate for surgery.
Select...
I am between 30 and 65 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (pre-operative), post surgery (6 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (pre-operative), post surgery (6 months)
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.
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a body mass index (BMI) between 25 and 34.9.I cannot or do not want to use a PAP machine.I am either under 30 or over 65 years old.I cannot attend follow-up visits after surgery.I am considered a good candidate for surgery.I am between 30 and 65 years old.You have been diagnosed with central sleep apnea based on a sleep test.You regularly use opioid pain medication.You have a very high body mass index (BMI).I cannot move my lower jaw forward more than 5 mm.I have an active jaw joint disorder.I have dental issues like loose teeth or severe gum disease.You have severe sleep apnea with more than 15 breathing pauses per hour.
Research Study Groups:
This trial has the following groups:- Group 1: RCMP titration
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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