NCT03929549 · University of Michigan
Preliminary Evaluation of a RCMP to Predict Failure of Maxillomandibular Advancement Surgery for OSA
What this study 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.
View original scientific description
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.
Interventions
DEVICE
RCMP titration
An overnight titration polysomnogram with gradual mandibular protrusion and assessment of polysomnographic parameters (i.e. AHI, oxygen saturation, etc.) at various magnitudes of protrusion.
Primary outcome measures
Primary outcome variable: Change in AHI (pre-post) with MMA surgery
Time frame: baseline (pre-operative), post surgery (6 months)
Secondary outcome variable: Failure of MMA surgery defined as AHI ≥ 15/hour
Primary predictor variable: Change in AHI, from baseline to maximal therapeutic protrusion, with RCMP study
Time frame: baseline (pre-operative), post surgery (6 months)
age, sex, BMI, AHI, retrognathia, airway collapse on forced inspiration, AHI reduction on RCMP titration and magnitude of advancement.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Ann Arbor, Michigan
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Data: ClinicalTrials.gov · synced Dec 9, 2024 · Source of record for eligibility and locations