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Workflow Validation of an In-Home Feedback Controlled Mandibular Positioner

NCT03616327 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2019-08-21

No results posted yet for this study

Summary

The purpose of the study is to test the workflow of the MATRx and MATRx plus feedback controlled mandibular positioner in its intended setting and considerations related to decision making by the care provider. The workflow includes the participant's recruitment into the study, the screening process, visits at the dentist, home sleep tests, and the decision made regarding oral appliance therapy based on the results of the sleep tests.

Conditions

Interventions

DEVICE

MATRx in-lab, MATRx plus

The MATRx remotely controlled mandibular positioner (RCMP) consists of temporary dental trays connected to an extra-oral linear actuator that protrudes the mandible. MATRx is used during polysomnography, where sleep and cardio-respiratory variables are recorded during sleep. The position of the mandible is controlled remotely by a sleep technologist, who moves the mandible while monitoring cardio-respiratory variables. The test determines if mandibular protrusion eliminates pharyngeal obstruction and the required protrusion. The MATRx plus is used in the home. Like the RCMP, the patient sleeps with the motorized mandibular positioner (MP) in place. However, the MP's position is controlled by a computer, making it a feedback controlled mandibular positioner (FCMP). The FCMP detects apneas and hypopneas in real time. Using this information, the controller decides when to move the mandible and by how much. The test predicts of therapeutic outcome with OA and provides a target protrusion.

Sponsors & Collaborators

  • Zephyr Sleep Technologies

    lead INDUSTRY

Principal Investigators

  • Kent Moore, DDS, MD · Charlotte Oral Surgery

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-01
Primary Completion
2019-08-15
Completion
2019-08-19
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03616327 on ClinicalTrials.gov