title: 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.
authors.affiliation: Advocate Heart Institute, Naperville, Illinois. Electronic address: mariarosa.costanzo@advocatehealth.com.
authors.forename: Maria Rosa
authors.initials: MR
authors.lastname: Costanzo
authors.affiliation: Division of Cardiology, Department of Medicine, Ohio State University, Columbus, Ohio.
authors.forename: Ralph
authors.initials: R
authors.lastname: Augostini
authors.affiliation: Division of Cardiology, Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.
authors.forename: Lee R
authors.initials: LR
authors.lastname: Goldberg
authors.affiliation: Department of Heart Diseases, Medical University, Military Hospital, Wroclaw, Poland.
authors.forename: Piotr
authors.initials: P
authors.lastname: Ponikowski
authors.affiliation: Bielefeld Medical Center, Bielefeld, Germany.
authors.forename: Christoph
authors.initials: C
authors.lastname: Stellbrink
authors.affiliation: Sleep physician, Bethesda North Hospital, Cincinnati, Ohio and Professor Emeritus, University of Cincinnati, Cincinnati, Ohio.
authors.forename: Shahrokh
authors.initials: S
authors.lastname: Javaheri
mesh_terms: D000368:Aged; D004599:Electric Stimulation Therapy / Q000295:instrumentation* / Q000379:methods; D004867:Equipment Design; D004869:Equipment Safety; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D008991:Monitoring, Physiologic / Q000379:methods; D018579:Patient Selection; D010791:Phrenic Nerve / Q000503:physiopathology*; D017286:Polysomnography / Q000379:methods; D011446:Prospective Studies; D011788:Quality of Life; D012720:Severity of Illness Index; D016037:Single-Blind Method; D020182:Sleep Apnea, Central / Q000175:diagnosis* / Q000523:psychology / Q000628:therapy*; D016896:Treatment Outcome
keywords: Central sleep apnea; phrenic nerve stimulation; randomized controlled trial; sleep