63
Participants
Start Date
December 13, 2017
Primary Completion Date
January 21, 2022
Study Completion Date
January 21, 2022
Therapeutic HGNS
Prior to enrollment in this study, the HGNS will have been implanted as part of clinical care, and a therapeutic voltage setting will have been determined via overnight sleep study The pulse generator, using technology from cardiac pacemakers, utilizes the signal from the pressure sensor for timing of stimulation to the tongue nerve. Patient will undergo activation of the implanted device one month post-operatively. A functional threshold (in volts) is obtained based on tongue motion during device stimulation. For the next month, the patient will have steadily increased stimulation strength by 0.1V every 2-3 nights within the preset range until the upper limit is reached.
Subtherapeutic 'Sham' HGNS
"Sham threshold determination will be performed as follows. The patient will be in a reclined position with the mouth open while nasal breathing. Stimulation will be increased from 0.1V up by 0.1V until bulk tongue motion is detected without obvious protrusion. This process is repeated twice and the average value is used to determine sham-HGNS. The electrode configuration will remain consistent between the patient's therapeutic and sham thresholds"
Hospital of the University of Pennsylvania, Philadelphia
American Heart Association
OTHER
American Academy of Sleep Medicine
OTHER
University of Pennsylvania
OTHER