The objective of the study is to determine the safety and preliminary efficacy in patients utilizing the aura6000 System for the treatment of Obstructive Sleep Apnea (OSA).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
The aura6000 device is an implanted hypoglossal nerve stimulator designed to maintain wakeful muscle tone of the tongue during sleep. It is implanted through a short surgical procedure. The implant is programmed to provide the optimal stimulation parameters for the patient. The therapy is controlled by a hand-held remote control allowing the patient to start, stop, and pause the therapy during times of sleep.
Clinique Univ. Saint-Luc
Brussels, Belgium
Mean change in AHI measured through in-lab polysomnography (PSG) compared to baseline.
Time frame: 3 and 12 months post-implant
Adverse events and Serious Adverse events peri and post-operatively
Time frame: 3 and 12 months post-operative
Mean change in Quality of Life outcomes measured with ESS (Epworth Sleepiness Scale) as compared to baseline.
Time frame: 3 and 12 months post-operative
Mean change in Quality of Life outcomes measured with FSS (Fatigue Severity Scale) as compared to baseline.
Time frame: 3 and 12 months post-implantation
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