Hypoglossal Nerve Stimulation on Cardiovascular Outcomes

NACompletedINTERVENTIONAL
Enrollment

63

Participants

Timeline

Start Date

December 13, 2017

Primary Completion Date

January 21, 2022

Study Completion Date

January 21, 2022

Conditions
Obstructive Sleep Apnea
Interventions
DEVICE

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.

DEVICE

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"

Trial Locations (1)

19104

Hospital of the University of Pennsylvania, Philadelphia

All Listed Sponsors
collaborator

American Heart Association

OTHER

collaborator

American Academy of Sleep Medicine

OTHER

lead

University of Pennsylvania

OTHER

NCT03359096 - Hypoglossal Nerve Stimulation on Cardiovascular Outcomes | Biotech Hunter | Biotech Hunter