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

Recruiting now · Not applicable

Conditions studied: Obstructive Sleep Apnea, Maxillomandibular Advancement Surgery

In brief

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.

Key facts

Study ID

NCT03929549

Run by

University of Michigan

People needed

20

Starts

2019-08-12

Expected to finish

2026-07-01

Last updated by the study team

2024-12-09

Who can join

Age: 30 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• AHI ≥ 15/hour
• 30-65 years of age
• BMI 25-34.9
• Ideal operative candidate
• Unable or unwilling to use PAP

You may not qualify if…

• 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

Where it is running

• Michigan Medicine Oral and Maxillofacial Surgery — Ann Arbor, Michigan, United States (enrolling)

Full record on ClinicalTrials.gov

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