Workflow Validation of an In-home Auto-titrating Mandibular Positioner

Status Completed

Clinical Trial Summary

The purpose of the study is to test the workflow of an auto-titrating mandibular positioner in its intended setting. Participants with obstructive sleep apnea will use the device to determine their eligibility for oral appliance therapy and provide feedback on usability of the device.

Clinical Trial Description

One treatment for obstructive sleep apnea is oral appliance therapy during sleep, in which an appliance that covers the upper and lower teeth acts to pull the lower jaw forward, opening the throat passage and allowing for normal breathing. However, oral appliance therapy does not treat sleep apnea effectively in all individuals. In order to identify those individuals for whom oral appliance therapy will work, the study sponsor has developed an investigational device called an auto-titrating mandibular positioner. The device automatically pulls the lower jaw forward in response to respiratory events while the individual sleeps. Study participants will learn the outcome of their sleep tests and will provide feedback on the ease of use of the device. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02933112
Study type	Interventional
Source	Zephyr Sleep Technologies
Contact
Status	Completed
Phase	N/A
Start date	October 2016
Completion date	October 11, 2018

View Details

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