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出境医 / 临床实验 / Use of RCMP to Predict Treatment Outcomes of Maxillomandibular Advancement Surgery for OSA

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

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 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.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
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 12, 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.
Other Name: Remotely Controlled Mandibular Positioner

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
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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
Contacts and Locations

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

Locations
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United States, Michigan
Michigan Medicine Oral and Maxillofacial Surgery Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Jennifer a Lay-Luskin, MPhil    734-936-5950    jalay@med.umich.edu   
Sponsors and Collaborators
University of Michigan
Investigators
Layout table for investigator information
Principal Investigator: Sharon Aronovich, DMD University of Michigan
Tracking Information
First Submitted Date  ICMJE April 24, 2019
First Posted Date  ICMJE April 29, 2019
Last Update Posted Date October 9, 2020
Actual Study Start Date  ICMJE August 12, 2019
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Use of RCMP to Predict Treatment Outcomes of Maxillomandibular Advancement Surgery for OSA
Official Title  ICMJE Use of Remotely Controlled Mandibular Positioner (RCMP) to Predict Treatment Outcomes of Maxillomandibular Advancement Surgery for Obstructive Sleep Apnea (OSA).
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Obstructive Sleep Apnea
  • Maxillomandibular Advancement Surgery
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: RCMP titration
Remotely Controlled Mandibular Positioner
Intervention: Device: RCMP titration
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 24, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2022
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jennifer Lay-Luskin 734-763-5963 jalay@med.umich.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03929549
Other Study ID Numbers  ICMJE HUM00143739
M-ROSA trial ( Other Identifier: University of Michigan )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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.: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: 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
Responsible Party Sharon Aronovich, University of Michigan
Study Sponsor  ICMJE University of Michigan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sharon Aronovich, DMD University of Michigan
PRS Account University of Michigan
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP