[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03929549":3,"trial-entities:NCT03929549":81,"trial-summary:NCT03929549":84},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":14,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":36,"secondary_outcomes":44,"sex":45,"minimum_age":46,"maximum_age":47,"healthy_volunteers":15,"eligibility_criteria":48,"std_ages":52,"locations":55,"central_contacts":71,"overall_officials":75,"references":79,"see_also_links":80},"NCT03929549","HUM00143739","Preliminary Evaluation of a RCMP to Predict Failure of Maxillomandibular Advancement Surgery for OSA","Preliminary Evaluation of a Remotely Controlled Mandibular Positioner to Predict Failure of Maxillomandibular Advancement Surgery for Obstructive Sleep Apnea","RECRUITING","2026-07","2024-12","2024-12-09","2019-08-12","University of Michigan","OTHER",false,"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.\n\nThis 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.","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.\n\nPatients 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.",[19,20],"Obstructive Sleep Apnea","Maxillomandibular Advancement Surgery",[],"INTERVENTIONAL",[24],"NA",{"count":26,"type":27},20,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"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.",[31],[35],"Remotely Controlled Mandibular Positioner",[37,41],{"measure":38,"description":39,"timeFrame":40},"Primary outcome variable: Change in AHI (pre-post) with MMA surgery","Secondary outcome variable: Failure of MMA surgery defined as AHI ≥ 15\u002Fhour","baseline (pre-operative), post surgery (6 months)",{"measure":42,"description":43,"timeFrame":40},"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.",[],"ALL","30 Years","65 Years",{"inclusion":49,"exclusion":50,"raw_text":51},[],[],"Inclusion Criteria:\n\nAHI ≥ 15\u002Fhour\n\n30-65 years of age\n\nBMI 25-34.9\n\nIdeal operative candidate\n\nUnable or unwilling to use PAP\n\nExclusion Criteria:\n\nBMI ≥ 35\n\nyounger than 30 or older than 65 years of age\n\npregnancy\n\nCentral sleep apnea (CSA) on baseline polysomnogram\n\nChronic opioid use\n\nActive TMJ Disorders\n\nInability to protrude the mandible beyond 5 mm\n\nInability to follow-up after surgery\n\nDental disorders including loose teeth or advanced periodontal disease",[53,54],"ADULT","OLDER_ADULT",[56],{"facility":57,"status":8,"city":58,"state":59,"zip":60,"country":61,"contacts":62,"geoPoint":68},"Michigan Medicine Oral and Maxillofacial Surgery","Ann Arbor","Michigan","48109","United States",[63],{"name":64,"role":65,"phone":66,"email":67},"Jennifer a Lay-Luskin, MPhil","CONTACT","734-936-5950","jalay@med.umich.edu",{"lat":69,"lon":70},42.27756,-83.74088,[72],{"name":73,"role":65,"phone":74,"email":67},"Jennifer Lay-Luskin","734-763-5963",[76],{"name":77,"affiliation":13,"role":78},"Sharon Aronovich, DMD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":82,"biomarkers":83},[19],[],{"nct_id":4,"found":85,"summary":86,"prompt_version":96},true,{"design":87,"status":88,"heading":89,"summary":90,"follow_up":91,"word_count":92,"commitments":93,"compensation":94,"drugs_mentioned":95},"This is an interventional study, meaning participants will receive a specific intervention. It plans to enroll 20 participants.","completed","Study on Maxillomandibular Advancement Surgery for Obstructive Sleep Apnea","This study is looking at how well Maxillomandibular Advancement (MMA) surgery works for people with moderate to severe Obstructive Sleep Apnea (OSA). Researchers want to see if a special device called a Remote Controlled Mandibular Positioner (RCMP) can predict who will benefit most from MMA surgery. The RCMP device helps find the best jaw position to improve breathing during sleep. You might be able to join if you are 30-65 years old, have an AHI (Apnea-Hypopnea Index, a measure of sleep apnea severity) of 15 or more, and a BMI (Body Mass Index) between 25 and 34.9. The study aims to see if changes in your AHI after using the RCMP device can predict how much your AHI will improve after MMA surgery. The study is currently unclear about its recruitment status and plans to enroll 20 participants.","Your AHI will be measured 6 months after surgery.",138,"You would undergo a special sleep study using the RCMP device, followed by Maxillomandibular Advancement (MMA) surgery. Your AHI will be measured before surgery and again 6 months after surgery.","Not stated in the trial record.",[],"v2"]