Preliminary Evaluation of a RCMP to Predict Failure of Maxillomandibular Advancement Surgery for OSA
Eligible age
30–65 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this 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.
Sponsor: University of Michigan
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
Where it's recruiting
Ann Arbor
Source: ClinicalTrials.gov · NCT03929549 · last updated 2024-12-09