At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Prospective Use of Awake Endoscopy to Direct Inspire Therapy for Obstructive Sleep Apnea
In Brief
A clinical study evaluating Awake endoscopy for Obstructive Sleep Apnea. Completed, enrolled 16 participants across 1 site.
Detailed Summary
The aim of this study is to examine a new method of device configuration for the Inspire upper airway stimulator. First, the investigators will attempt to determine optimal configuration by quantifying changes in upper airway size with different implant configurations using awake nasal endoscopy. The configuration/voltage that results in the greatest increase in upper airway size and is tolerated by the patient will be selected. Participants will then undergo a sleep study so that increased airway size may be correlated with changes in sleep study parameters including AHI and oxygen desaturation index (ODI). Airway size and sleep study parameters using the standard device configuration (+-+)/voltage will be compared to airway size and sleep study parameters using the test, or "optimal," configuration/voltage to determine the usefulness of awake endoscopy in activation of the Inspire device.
Study Details
Timeline
Interventions
Awake endoscopic exam will be performed to measure airway size in the retropalatal and retroglossal upper airway regions using different Inspire implant configurations and voltages. The optimal test configuration determined on endoscopy will be tested during a sleep study and compared to the standard-of-care device configuration, with improvements in sleep study outcomes indicating that awake endoscopy is useful during Inspire implant activation.