Home › Obstructive Sleep Apnea › NCT03929549

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

Preliminary Evaluation of a Remotely Controlled Mandibular Positioner to Predict Failure of Maxillomandibular Advancement Surgery for Obstructive Sleep Apnea

Who can join

Ages 30 to 65 · All sexes

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

About the study

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, may help customize treatment options for patients with OSA by providing predictive value.

What is being tested

• RCMP titration (device)

Sponsor: University of Michigan · Participants: 20 · Started: Aug 12, 2019

Contact the study team

• Jennifer Lay-Luskin · Phone: 734-763-5963

Official record on ClinicalTrials.gov — NCT03929549

Locations in the U.S.

Conditions

• Obstructive Sleep Apnea

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.