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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. Identifier: NCT00909259
Recruitment Status : Completed
First Posted : May 27, 2009
Last Update Posted : January 6, 2014
Information provided by (Responsible Party):
Respicardia, Inc.

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.

Condition or disease Intervention/treatment Phase
Sleep Disordered Breathing Cheyne-Stokes Respiration Sleep Apnea Device: Phrenic stimulation device Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility Study to Determine the Effects of Phrenic Nerve Stimulation in Patients With Periodic Breathing
Study Start Date : October 2007
Actual Primary Completion Date : September 2010
Actual Study Completion Date : December 2013

Arm Intervention/treatment
Experimental: Phrenic Stimulation 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.

Primary Outcome Measures :
  1. The primary goal of this feasibility study is to show an acute improvement in respiration. [ Time Frame: Acute (up to 2 nights of sleep) ]
  2. 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. ]

Secondary Outcome Measures :
  1. Characterization of chronic safety of stimulating the phrenic nerve (Stage 2 of study). [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00909259

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United States, Minnesota
Hennepin County Medical Center
Minneapolis, Minnesota, United States
United States, Ohio
Ohio Heart Hospital
Cincinnati, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
Jiangsu Province Hospital
Nanjing, China
Polish Military Hospital
Wroclaw, Poland
Sponsors and Collaborators
Respicardia, Inc.
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Respicardia, Inc. Identifier: NCT00909259    
Other Study ID Numbers: CCI-Feasibility
First Posted: May 27, 2009    Key Record Dates
Last Update Posted: January 6, 2014
Last Verified: January 2014
Keywords provided by Respicardia, Inc.:
Sleep Disordered Breathing
Periodic Breathing
Cheyne-Stokes Respiration
Sleep Apnea
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Respiratory Aspiration
Cheyne-Stokes Respiration
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Pathologic Processes
Signs and Symptoms, Respiratory
Signs and Symptoms