Preliminary Evaluation of a RCMP to Predict Failure of Maxillomandibular Advancement Surgery for OSA
NCT ID: NCT03929549
Last Updated: 2024-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2019-08-12
2026-07-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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RCMP titration
Remotely Controlled Mandibular Positioner
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
30-65 years of age
BMI 25-34.9
Ideal operative candidate
Unable or unwilling to use PAP
Exclusion Criteria
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
30 Years
65 Years
ALL
No
Sponsors
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University of Michigan
OTHER
Responsible Party
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Sharon Aronovich
Clinical Assistant Professor of Dentistry, Department of Oral and Maxillofacial Surgery, School of Dentistry and Assistant Professor of Oral Surgery
Principal Investigators
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Sharon Aronovich, DMD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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Michigan Medicine Oral and Maxillofacial Surgery
Ann Arbor, Michigan, United States
Countries
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Central Contacts
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Facility Contacts
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Jennifer a Lay-Luskin, MPhil
Role: primary
Other Identifiers
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M-ROSA trial
Identifier Type: OTHER
Identifier Source: secondary_id
HUM00143739
Identifier Type: -
Identifier Source: org_study_id