Clinical trial NCT01124370: Chronic Evaluation of Respicardia Therapy
Official title: Safety and Efficacy Evaluation of Respicardia Therapy for Central Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sleep Disordered Breathing
Cheyne Stokes Respiration
Periodic Breathing
Sleep Apnea
Central Sleep Apnea
Keywords: Sleep Disordered Breathing
Cheyne Stokes Respiration
Periodic Breathing
Sleep Apnea
Central Sleep Apnea
Lead sponsor: Respicardia, Inc.
Sponsor class: INDUSTRY
First posted: 2010-05-17
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the chronic safety and efficacy of phrenic nerve stimulation on central sleep apnea (CSA). Clinically, CSA events translate into sleep fragmentation, excessive daytime sleepiness, reduced exercise capacity, and possibly ventricular arrhythmias.

The study is chronic in nature, such that subjects will undergo the implantation of an implantable pulse generator and stimulation lead. A sensing lead may also be placed during the initial implant procedure. Subjects will be followed for up to six-months on therapy to assess respiratory and heart failure outcomes. Following the six-month therapy visit, subjects will enter into a long-term follow-up phase until the completion of the study.

It is anticipated that data obtained in this study will show that the proposed intervention can modify respiration with a low incidence of adverse effects. The results of this trial are intended to be used to develop a subsequent protocol for pivotal study.


Eligibility criteria: Inclusion Criteria:

* Candidate is at least 18 years old
* Candidates with known recent history of Periodic Breathing, as evidenced by an overnight polysomnogram (PSG) within 60 days of the implant procedure demonstrating:

  * Apnea-Hypopnea Index (AHI) greater than or equal to 20 events/hr
  * Predominantly central origin (central apnea events comprise 50% or more of all apnea events)
  * Limited obstructive events (obstructive apneas comprise less than 20% of the AHI)

Exclusion Criteria:

* Candidates who are pregnant
* Candidates with baseline oxygen saturation less than or equal to 90% on a stable FiO2
* Candidates with severe COPD
* Candidates with a history of cerebrovascular accident (CVA), myocardial infarction, coronary artery bypass grafting (CABG) surgery, or percutaneous coronary intervention (PCI) within the 3 months prior to the study
* Candidates with unstable angina
* Candidates with history of primary pulmonary hypertension

Primary outcomes:
measure: AHI Change From Baseline at 3 Months
timeFrame: Baseline and 3 months on therapy
Secondary outcomes:
measure: Related Adverse Events
timeFrame: Up to 2 years
measure: Epworth Sleepiness Scale Change From Baseline at 6 Months
timeFrame: Baseline and 6 months on therapy
measure: Minnesota Living With Heart Failure Questionnaire Change From Baseline at 6 Months
timeFrame: Baseline and 6 months on therapy
measure: Heart Failure Clinical Composite
timeFrame: 6 months on therapy
measure: Six-minute Hall Walk Test Change From Baseline at 6 Months
timeFrame: Baseline and 6 months on therapy
measure: NYHA Functional Class Improvement From Baseline to 6 Months
timeFrame: Baseline and 6 months on therapy
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: BryanLGH Heart Institute
state: Nebraska
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Lancaster
country: United States
facility: Lancaster Heart and Stroke Foundation
state: Pennsylvania
city: Nashville
country: United States
facility: St. Thomas Heart
state: Tennessee
city: Norfolk
country: United States
facility: Sentara Cardiovascular Research Institute
state: Virginia
city: Bad Oeynhausen
country: Germany
facility: Heart and Diabetes Center
city: Kiel
country: Germany
facility: University of Kiel
city: Köln
country: Germany
facility: Köln University
city: Reinbek
country: Germany
facility: St. Adolf-Stift Hospital
city: Monza
country: Italy
facility: Policlinico di Monza-IRCCS
city: Krakow
country: Poland
facility: Jagiellonian University
city: Warsaw
country: Poland
facility: Medical Military Institute
city: Wroclaw
country: Poland
facility: 4th Military Hospital
Study officials:
affiliation: 4th Military Clinical Hospital with Polyclinic, Poland
name: Piotr Ponikowski, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ohio State University
name: William T Abraham, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Javaheri S, McKane SW, Cameron N, Germany RE, Malhotra A. In patients with heart failure the burden of central sleep apnea increases in the late sleep hours. Sleep. 2019 Jan 1;42(1):zsy195. doi: 10.1093/sleep/zsy195.
citation: Abraham WT, Jagielski D, Oldenburg O, Augostini R, Krueger S, Kolodziej A, Gutleben KJ, Khayat R, Merliss A, Harsch MR, Holcomb RG, Javaheri S, Ponikowski P; remede Pilot Study Investigators. Phrenic nerve stimulation for the treatment of central sleep apnea. JACC Heart Fail. 2015 May;3(5):360-369. doi: 10.1016/j.jchf.2014.12.013. Epub 2015 Mar 11.