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Feasibility Study to Determine the Effects of Phrenic Nerve Stimulation in Patients With Periodic Breathing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00909259
Recruitment Status : Completed
First Posted : May 27, 2009
Last Update Posted : January 6, 2014
Sponsor:
Information provided by (Responsible Party):
Respicardia, Inc.

Tracking Information
First Submitted Date  ICMJE May 21, 2009
First Posted Date  ICMJE May 27, 2009
Last Update Posted Date January 6, 2014
Study Start Date  ICMJE October 2007
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 22, 2009)
  • The primary goal of this feasibility study is to show an acute improvement in respiration. [ Time Frame: Acute (up to 2 nights of sleep) ]
  • The primary safety endpoint of the study is the absence of adverse events related to stimulation that result in hospitalization, the prolongation of an existing hospitalization, or death of the patient. [ Time Frame: Acute (up to 2 nights of sleep) plus post-operative assessment at one week (5-10 days) or until resolution of an observed adverse event. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 8, 2011)
Characterization of chronic safety of stimulating the phrenic nerve (Stage 2 of study). [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Feasibility Study to Determine the Effects of Phrenic Nerve Stimulation in Patients With Periodic Breathing
Official Title  ICMJE Feasibility Study to Determine the Effects of Phrenic Nerve Stimulation in Patients With Periodic Breathing
Brief Summary

The purpose of this feasibility study is to determine the effect of stimulating the phrenic nerve to treat periodic breathing (a pattern of breathing characterized by hyperpneas followed by hypopneas or apneas). Clinically, these physiologic events translate into sleep fragmentation, excessive daytime sleepiness, reduced exercise capacity, and possibly ventricular arrhythmias.

Stage 1 of the study is acute in nature, such that subjects will undergo the placement of a stimulation lead, followed by assessment of stimulation of the phrenic nerve using the lead for up to 2 nights of sleep. A sensing lead may also be placed during the initial implant procedure. Observational data will be obtained and stimulation provided using an externalized system connected to the study leads. Following the study, all investigational components will be removed from the patient.

Stage 2 of the study is being conducted at one of the participating sites to determine the initial safety of chronic stimulation of the phrenic nerve in a limited number of patients with sleep disordered breathing. It is anticipated that data obtained in this feasibility 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 a multi-center study of chronic phrenic nerve pacing.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Sleep Disordered Breathing
  • Cheyne-Stokes Respiration
  • Sleep Apnea
Intervention  ICMJE Device: Phrenic stimulation device
In Stage 1, a stimulation lead will be introduced via standard access methods and positioned to provide stimulation. A second lead may also be placed for sensing purposes. The proximal portions of the implanted lead(s) will remain externalized such that stimulation and observation can be made using external stimulation and recording equipment. Study subjects will be observed and stimulation will be performed for up to 2 nights of sleep in a clinically supported environment. In Stage 2, a stimulation device and lead will be permanently implanted.
Study Arms  ICMJE Experimental: Phrenic Stimulation
Intervention: Device: Phrenic stimulation device
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: May 22, 2009)
50
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient is 18 years of age or older
  • Patient has a demonstrated history of periodic breathing (symptoms may include sleep fragmentation, as reported by patient or as witnessed by another person, night arousal after apneic episodes, reduced exercise capacity, and daytime sleepiness)
  • Patient is expected to be able to tolerate the procedure and remain clinically stable for the duration of the study (e.g. the subject is able to lie down long enough to insert the lead(s) without shortness of breath and the subject is able to tolerate instrumentation during study).
  • Patient or their legal representative is willing and able to sign an IRB/MEC approved informed consent (and a privacy protection authorization in the United States)

Exclusion Criteria:

  • Baseline oxygen saturation less than or equal to 90% on a stable FIO2
  • Evidence of phrenic nerve palsy
  • Temperature > 38.0 degrees Celsius
  • Inability to place catheter (e.g. previously known coagulopathy, distorted anatomy, etc.)
  • Patient is currently enrolled in another study that may confound the results of this study
  • Patient for whom informed consent cannot be obtained
  • Patient who is pregnant or of child bearing potential without a negative pregnancy test within 10 days of the study procedure
  • Patients implanted with a pacemaker, implantable defibrillator, or cardiac resynchronization device who are unable to tolerate turning off the device for the duration of the system testing procedure (based on medical judgment)
  • Patients with severe COPD (per GOLD scale)
  • Patients with a history of myocardial infarction within 6 months prior to the study
  • Patients with unstable angina
  • Patients who are intolerant of or allergic to contrast dye
  • Patients who are contraindicated for <1mg of steroid (on the stimulation lead).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China,   Poland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00909259
Other Study ID Numbers  ICMJE CCI-Feasibility
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Respicardia, Inc.
Study Sponsor  ICMJE Respicardia, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Respicardia, Inc.
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP