Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT03929549
NA

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

Sponsor: University of Michigan

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

30 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2019-08-12

Completion Date

2026-07

Last Updated

2024-12-09

Healthy Volunteers

No

Interventions

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 (1)

Michigan Medicine Oral and Maxillofacial Surgery

Ann Arbor, Michigan, United States