Preliminary Evaluation of a RCMP to Predict Failure of Maxillomandibular Advancement Surgery for OSA
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-65
SponsorUniversity of Michigan
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
RCMP titration
DeviceAn overnight titration polysomnogram with gradual mandibular protrusion and assessment of polysomnographic parameters (i.e. AHI, oxygen saturation, etc.) at various magnitudes of protrusion.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: RCMP titrationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Primary outcome variable: Change in AHI (pre-post) with MMA surgery
Secondary outcome variable: Failure of MMA surgery defined as AHI ≥ 15/hour
Time frame
baseline (pre-operative), post surgery (6 months)2
Primary predictor variable: Change in AHI, from baseline to maximal therapeutic protrusion, with RCMP study
age, sex, BMI, AHI, retrognathia, airway collapse on forced inspiration, AHI reduction on RCMP titration and magnitude of advancement.
Time frame
baseline (pre-operative), post surgery (6 months)Sponsors and contacts
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Source ClinicalTrials.gov