Design of the remedē System Therapy (rēST) study: A prospective non-randomized post-market study collecting clinical data on safety and effectiveness of the remedē system for the treatment of central sleep apnea
Sleep Medicine(2022)
Abstract
•There is a lack of established therapies to treat central sleep apnea (CSA).•The remedē System treats CSA by stimulating the phrenic nerve to generate a breath.•The remedē System Therapy Study will assess 5-year safety and efficacy of transvenous phrenic nerve stimulation.•The study design is a prospective, single arm, international, multi-site study.•Assessments include polysomnogram, echocardiogram, biomarkers, and questionnaires.
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Key words
Central sleep apnea,Transvenous phrenic nerve stimulation,Sleep
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