Improving the Efficiency of the Digital Sleep Workflow Using MATRx Plus

Completed

Conditions studied: Obstructive Sleep Apnea

In brief

Sleep apnea (OSA) is a condition in which the air passage in the throat closes or partly closes during sleep and repeatedly interrupts breathing. The standard treatment for sleep apnea is continuous positive airway pressure (CPAP), but it is not suitable for all patients. Another treatment is to use an oral appliance in your mouth when you sleep. The appliance covers the upper and lower teeth and pulls the lower jaw forward, opening the airway and allowing normal breathing. Oral appliance treatment does not treat sleep apnea effectively in all patients. To identify patients for whom oral appliance therapy will work, Zephyr Sleep Technologies invented a device that tests various positions of the lower jaw from the comfort of your own home. The MATRx plus device is considered investigational since it has not been cleared by the U.S. FDA. During the MATRx plus test, the patient sleeps with a motorized positioner that moves the lower jaw. Jaw movement is automatically controlled by a computer, making the device a feedback controlled mandibular positioner. The purpose of the study is to test the workflow of the MATRx plus feedback controlled mandibular positioner in its intended setting. The workflow includes 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. The main objective is to determine the turnaround time of a MATRx plus test in a real-use dental setting.

Key facts

Study ID
NCT03579225
Run by
Zephyr Sleep Technologies
People needed
6
Starts
2018-07-01
Expected to finish
2019-04-14
Last updated by the study team
2019-04-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Where it is running

Full record on ClinicalTrials.gov

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