Design of the remedē System Pivotal Trial: A Prospective, Randomized Study in the Use of Respiratory Rhythm Management to Treat Central Sleep Apnea

Abstract

Background: Central sleep apnea is common in patients with cardiovascular disease and worsens outcomes. There is a lack of established therapies for central sleep apnea, and those available are limited by poor patient adherence and potentially adverse cardiovascular effects, at least in a subset of patients. The remedē System (Respicardia, Minnetonka, Minnesota) is a new physiologic treatment that uses transvenous phrenic nerve stimulation to contract the diaphragm, thereby stabilizing gas exchange and restoring normal breathing throughout the sleep period.

Methods: This is a prospective multicenter randomized trial with blinded end points evaluating the safety and efficacy of the remedē System. Up to 173 patients with central sleep apnea will be randomized 1:1 to remedē System therapy initiated at 1 month after implantation (treatment) or to an implanted remedē System that will remain inactive for 6 months (control). Primary efficacy end point is the percentage of patients who experience a reduction in apnea-hypopnea index by a ≥ 50% at 6 months (responder analysis). Primary safety end point is freedom from serious adverse events through 12 months. Secondary end points include sleep-disordered breathing parameters, sleep architecture, Epworth Sleepiness Scale score, and Patient Global Assessment.

Conclusions: This is the 1st randomized controlled trial of the safety and efficacy of the remedē System for the treatment of central sleep apnea.

Trial registration: ClinicalTrials.gov NCT01816776.

Keywords: Central sleep apnea; phrenic nerve stimulation; randomized controlled trial; sleep.