At a glance
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Upper AIRway Implanted Nerve STIMulation Therapy: A Breakthrough in Obstructive Sleep Apnea Therapy
In Brief
A clinical study evaluating Activated Inspire® Upper Airway Stimulation System and Inactivated Inspire® Upper Airway Stimulation System for Obstructive Sleep Apnea Syndrome. Completed, enrolled 7 participants across 1 site.
Detailed Summary
Continuous positive airway pressure (CPAP) is the gold standard to normalize breathing during sleep in patients with obstructive sleep apnea syndrom (OSA). Many patients will not tolerate or will not accept CPAP. Implanted nerve stimulation is a novel therapy for OSA patients that restores the upper airway potency using unilateral XII nerve electric stimulation. The principal objective of this study is short-term efficacy of a new treatment for OSA on blood pressure variability during sleep.
Study Details
Timeline
Interventions
At first, INSPIRE® device will be active a month
After 15 days "wash-out" INSPIRE® device will be inactivated for a second period of one month.