Obstructive Sleep Apnea Clinical Trial
Official title:
A Study for Obstructive Sleep Apnea Using a New At-Home Sleep Test
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.
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.
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