Preliminary Evaluation of a RCMP to Predict Failure of Maxillomandibular Advancement Surgery for OSA

Obstructive Sleep Apnea Clinical Trial

Official title:

Preliminary Evaluation of a Remotely Controlled Mandibular Positioner to Predict Failure of Maxillomandibular Advancement Surgery for Obstructive Sleep Apnea

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03929549
• Other study ID #: HUM00143739
• Secondary ID: M-ROSA trial
• Status: Recruiting
• Phase: N/A
• Start date: August 12, 2019
• Est. completion date: July 2026

Study information

• Verified date: November 2023
• Source: University of Michigan
• Contact: Jennifer Lay-Luskin
• Phone: 734-763-5963
• Email: jalay[@]med.umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

Inclusion Criteria:

AHI = 15/hour

30-65 years of age

BMI 25-34.9

Ideal operative candidate

Unable or unwilling to use PAP

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Maxillomandibular Advancement Surgery
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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.

Locations

Country	Name	City	State
United States	Michigan Medicine Oral and Maxillofacial Surgery	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary outcome variable: Change in AHI (pre-post) with MMA surgery	Secondary outcome variable: Failure of MMA surgery defined as AHI = 15/hour	baseline (pre-operative), post surgery (6 months)
Primary	Primary predictor variable: Change in AHI, from baseline to maximal therapeutic protrusion, with RCMP study	age, sex, BMI, AHI, retrognathia, airway collapse on forced inspiration, AHI reduction on RCMP titration and magnitude of advancement.	baseline (pre-operative), post surgery (6 months)