Use of RCMP to Predict Treatment Outcomes of Maxillomandibular Advancement Surgery for OSA
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|ClinicalTrials.gov Identifier: NCT03929549|
Recruitment Status : Not yet recruiting
First Posted : April 29, 2019
Last Update Posted : July 24, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea Maxillomandibular Advancement Surgery||Device: RCMP titration||Not Applicable|
The use of a remotely controlled mandibular protrusion (RCMP) device allows for customization of treatment by titrating the extent of mandibular protrusion during a polysomnogram. Use of the RCMP device has a high degree of positive and negative predictive value in determining the effectiveness and degree (effective target protrusive position) of mandibular advancement need with oral appliance therapy (Remmers, 2013). Preliminary data from 4 patients (Hoekena 2006) indicates that patients with a significant response to oral appliance therapy (>50% reduction in AHI) may have a better response to MMA. This study will determine the efficacy of MMA in patients with moderate to severe OSA, and determine if the RCMP titration can predict success or failure with MMA for treatment of OSA.
Patients will undergo detailed history and physical examination by Oral & Maxillofacial Surgery. Those patients found to be potential candidates for jaw advancement (MMA) surgery will be recruited to enroll in the study. Once consented and enrolled, study participants will undergo a titration study using a remote controlled mandibular positioner (RCMP titration study) to evaluate changes in polysomnographic parameters (i.e. Apnea-hypopnea index and oxygen saturation) with mandibular protrusion. Patients will then undergo maxillomandibular advancement surgery (MMA surgery). During MMA surgery, a standard 10 mm advancement of the upper and lower jaw is performed. Slight modifications may be made to the degree of advancement in order to achieve acceptable facial esthetics. Data from the RCMP titration study will not affect how the MMA surgery is performed. After surgery, participants will have a follow-up polysomnogram four to eight months post-operatively to assess for treatment response and compared this to the predicted response based on the RCMP titration study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Use of Remotely Controlled Mandibular Positioner (RCMP) to Predict Treatment Outcomes of Maxillomandibular Advancement Surgery for Obstructive Sleep Apnea (OSA).|
|Estimated Study Start Date :||November 2019|
|Estimated Primary Completion Date :||October 2021|
|Estimated Study Completion Date :||April 2022|
Experimental: RCMP titration
Remotely Controlled Mandibular Positioner
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.
Other Name: Remotely Controlled Mandibular Positioner
- Change in Apnea-hypopnea indexes (AHI) before and after surgery [ Time Frame: baseline (pre-operative), post surgery (6 months) ]A fifty percent or greater reduction in AHI with a AHI value less than 15 after surgery is considered a successful MMA surgery.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03929549
|Contact: Jennifer Lay-Luskinfirstname.lastname@example.org|
|Principal Investigator:||Sharon Aronovich, DMD||University of Michigan|