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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

30-65 years of age

Must not have

Younger than 30 or older than 65 years of age

Inability to follow-up after surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (pre-operative), post surgery (6 months)

Awards & highlights

No Placebo-Only Group

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.

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.

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 between 30 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am either under 30 or over 65 years old.

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I cannot attend follow-up visits after surgery.

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I cannot move my lower jaw forward more than 5 mm.

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I have an active jaw joint disorder.

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I have dental issues like loose teeth or severe gum disease.

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)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Primary predictor variable: Change in AHI, from baseline to maximal therapeutic protrusion, with RCMP study

variable: Change in AHI (pre-post) with MMA surgery

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: RCMP titrationExperimental Treatment1 Intervention

Remotely Controlled Mandibular Positioner

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor

1,854 Previous Clinical Trials

6,433,541 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.