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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 65
Healthy Volunteers: f
View:

• AHI ≥ 15/hour

• 30-65 years of age

• BMI 25-34.9

• Ideal operative candidate

• Unable or unwilling to use PAP

Locations
United States
Michigan
Michigan Medicine Oral and Maxillofacial Surgery
RECRUITING
Ann Arbor
Contact Information
Primary
Jennifer Lay-Luskin
jalay@med.umich.edu
734-763-5963
Time Frame
Start Date: 2019-08-12
Estimated Completion Date: 2026-07
Participants
Target number of participants: 20
Treatments
Experimental: RCMP titration
Remotely Controlled Mandibular Positioner
Related Therapeutic Areas
Sponsors
Leads: University of Michigan

This content was sourced from clinicaltrials.gov