The overall goal of the study is to evaluate the safety, efficacy and therapy settings of the Hypoglossal Nerve Stimulation (HGNS) System for stimulating the hypoglossal nerve to help maintain airway opening in subjects with Obstructive Sleep Apnea (OSA).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
The Apnex Hypoglossal Nerve Stimulation System (HGNS) is an implanted medical device that is designed to prevent the tongue from blocking the airway during sleep. It is fully automatic and can be implanted during a simple surgical procedure. After it is implanted, the device is programmed to meet the unique needs of each patient. The device is on when the patient is sleeping and off when the patient is awake.
University of California San Francisco
San Francisco, California, United States
Saint Vincent Hospital
Indianapolis, Indiana, United States
University of Minnesota
Minneapolis, Minnesota, United States
Clinilabs, Inc.
New York, New York, United States
Mean change in AHI measured with in-lab nighttime polysomnography (PSG) compared to baseline
Time frame: 6 months post-implant
Mean change in functional outcomes measured with the Functional Outcomes Sleep Questionnaire (FOSQ) compared to baseline
Time frame: 6 months post-implant
The frequency of serious adverse events.
Time frame: One month post-implant.
The frequency of serious adverse events.
Time frame: 3 months post-implant.
The frequency of serious adverse events.
Time frame: 6 months post-implant.
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