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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

Use of RCMP to Predict Treatment Outcomes of Maxillomandibular Advancement Surgery for OSA

Clinicaltrials.gov identifier NCT03929549

Recruitment Status Recruiting

First Posted April 29, 2019

Last update posted October 9, 2020

Study Description

Brief summary:

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:Obstructive Sleep Apnea
    Maxillomandibular Advancement Surgery
  • Intervention/Treatment: Device: RCMP titration
  • Phase: N/A
Detailed Description

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 Design
  • Study Type: Interventional
  • Estimated Enrollment: 20 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Other
  • Official Title: Use of Remotely Controlled Mandibular Positioner (RCMP) to Predict Treatment Outcomes of Maxillomandibular Advancement Surgery for Obstructive Sleep Apnea (OSA).
  • Actual Study Start Date: August 2019
  • Estimated Primary Completion Date: October 2021
  • Estimated Study Completion Date: April 2022
Arms and interventions
Arm Intervention/treatment
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.
Outcome Measures
  • Primary Outcome Measures: 1. 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.
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

- Moderate to severe OSA (AHI>15 )

- Age 18 years or older

- BMI<40, - Baseline polysomnogram completed within the last 12 months with no significant weight changes (<10 lbs. weight fluctuation). - The baseline sleep study must be diagnostic with adequate sample Exclusion Criteria: - BMI ≥ 40 - pregnancy - Central sleep apnea (CSA) - 5 or more central apneas per hour - Psychoactive medications that influence sleep - Chronic opioid use - Other sleep disorders - Active temporomandibular joint (TMJ) Disorders - Fibromyalgia with significant facial pain - Inability to protrude the mandible beyond 5 mm - Inability to follow-up after surgery - Uncontrolled psychiatric disorders - Dental disorders including loose teeth and periodontal disease

Contacts and Locations
Contacts

Contact: Jennifer Lay-Luskin 734-763-5963 jalay@med.umich.edu

Locations

United States, Michigan
Michigan Medicine Oral and Maxillofacial Surgery
Ann Arbor

Sponsors and Collaborators

University of Michigan

Investigators

Principal Investigator: Sharon Aronovich, DMD University of Michigan

More Information
  • Responsible Party: University of Michigan
  • ClinicalTrials.gov Identifier: NCT03929549 History of Changes
  • Other Study ID Numbers: HUM00143739, M-ROSA trial
  • First Posted: April 29, 2019 Key Record Dates
  • Last Update Posted: October 9, 2020
  • Last Verified: October 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Yes
  • Plan Description: We will share deidentified individual patient data which supports the results reported in research publications. The data will be published as supplemental files with the original publication.
  • Supporting Materials: Study Protocol, Informed Consent Form (ICF), Clinical Study Report (CSR)
  • Time Frame: Upon publication (Deidentified individual patient data may be published as supplemental files to an original research paper)
  • Access Criteria: Deidentified individual patient data shared with a published paper will be published as supplemental files with the original publication
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: Yes
  • Product Manufactured in and Exported from the U.S.: Yes
  • Additional relevant MeSH terms: Sleep Apnea Syndromes Sleep Apnea, Obstructive