Actively Recruiting
Preliminary Evaluation of a RCMP to Predict Failure of Maxillomandibular Advancement Surgery for OSA
Led by University of Michigan · Updated on 2024-12-09
20
Participants Needed
1
Research Sites
359 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Preliminary Evaluation of a RCMP to Predict Failure of Maxillomandibular Advancement Surgery for OSA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Apnea-hypopnea index (AHI) of 15 or greater per hour
- Age between 30 and 65 years
- Body mass index (BMI) between 25 and 34.9
- Suitable candidate for surgery
- Unable or unwilling to use positive airway pressure (PAP) therapy
You will not qualify if you...
- Body mass index (BMI) of 35 or higher
- Younger than 30 or older than 65 years
- Pregnancy
- Central sleep apnea diagnosed on baseline sleep study
- Chronic opioid use
- Active temporomandibular joint (TMJ) disorders
- Inability to protrude the lower jaw more than 5 millimeters
- Unable to attend follow-up visits after surgery
- Dental problems such as loose teeth or severe gum disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Michigan Medicine Oral and Maxillofacial Surgery
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
Research Team
J
Jennifer Lay-Luskin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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