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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
Sponsor:
Information provided by (Responsible Party):
Sharon Aronovich, University of Michigan

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 Intervention/treatment Phase
Obstructive Sleep Apnea Maxillomandibular Advancement Surgery Device: RCMP titration Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
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).
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

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.
Other Name: Remotely Controlled Mandibular Positioner




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.



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

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


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

Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Sharon Aronovich, DMD University of Michigan

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Responsible Party: Sharon Aronovich, Clinical Assistant Professor of Dentistry, Department of Oral and Maxillofacial Surgery, School of Dentistry and Assistant Professor of Oral Surgery, University of Michigan
ClinicalTrials.gov Identifier: NCT03929549     History of Changes
Other Study ID Numbers: HUM00143739
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases