RecruitingNot ApplicableNCT03929549

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


Sponsor

University of Michigan

Enrollment

20 participants

Start Date

Aug 12, 2019

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 30 YearsMax Age: 65 Years

Inclusion Criteria5

  • AHI ≥ 15/hour
  • years of age
  • BMI 25-34.9
  • Ideal operative candidate
  • Unable or unwilling to use PAP

Exclusion Criteria9

  • BMI ≥ 35
  • 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

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Interventions

DEVICERCMP 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.


Locations(1)

Michigan Medicine Oral and Maxillofacial Surgery

Ann Arbor, Michigan, United States

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NCT03929549


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