Workflow Validation of an In-Home Feedback Controlled Mandibular Positioner

NACompletedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

November 1, 2017

Primary Completion Date

August 15, 2019

Study Completion Date

August 19, 2019

Conditions
Obstructive Sleep Apnea
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.

Trial Locations (1)

28207

Charlotte Oral Surgery, Charlotte

All Listed Sponsors
lead

Zephyr Sleep Technologies

INDUSTRY

NCT03616327 - Workflow Validation of an In-Home Feedback Controlled Mandibular Positioner | Biotech Hunter | Biotech Hunter