Prospective Use of Awake Endoscopy for Inspire Activation
Completed · Not applicable
Conditions studied: Obstructive Sleep Apnea
In brief
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.
Key facts
- Study ID
- NCT03990298
- Run by
- University of Pennsylvania
- People needed
- 16
- Starts
- 2018-11-01
- Expected to finish
- 2020-06-09
- Last updated by the study team
- 2021-08-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients with moderate to severe OSA who have undergone Inspire UAS implantation by the principal investigator
- Must have symptoms of OSA prior to Inspire implantation
- AHI between 15 and 65, where central and mixed apnea is 25% or more, and the level of collapse is in the soft palate area BMI less than 32
- Age 18 or above
You may not qualify if…
- Significant central sleep apnea
- Presence of other sleep disorders
- History of neurologic or neuromuscular disease
- Historical or present substance abuse
- Bleeding disorders
- Autoimmune diseases that increase risk of nasal trauma such as Wegener's, Sarcoidosis, etc.
- Pregnancy
Where it is running
- Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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