Feasibility Study to Determine the Effects of Phrenic Nerve Stimulation in Patients With Periodic Breathing - Full Text View

Sponsor:	Respicardia, Inc.
Information provided by (Responsible Party):	Respicardia, Inc.
ClinicalTrials.gov Identifier:	NCT00909259

Purpose

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	Intervention	Phase
Sleep Disordered Breathing Cheyne-Stokes Respiration Sleep Apnea	Device: Phrenic stimulation device	Phase I

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Feasibility Study to Determine the Effects of Phrenic Nerve Stimulation in Patients With Periodic Breathing

Resource links provided by NLM:

MedlinePlus related topics: Sleep Apnea

U.S. FDA Resources

Further study details as provided by Respicardia, Inc.:

Primary Outcome Measures:

The primary goal of this feasibility study is to show an acute improvement in respiration. [ Time Frame: Acute (up to 2 nights of sleep) ] [ Designated as safety issue: No ]
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. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Characterization of chronic safety of stimulating the phrenic nerve (Stage 2 of study). [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	50
Study Start Date:	October 2007
Estimated Study Completion Date:	December 2012
Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Arms

Assigned Interventions

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00909259

Locations

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
China
Jiangsu Province Hospital
Nanjing, China
Poland
Polish Military Hospital
Wroclaw, Poland

Sponsors and Collaborators

Respicardia, Inc.

More Information

No publications provided

Responsible Party:	Respicardia, Inc.
ClinicalTrials.gov Identifier:	NCT00909259 History of Changes
Other Study ID Numbers:	CCI-Feasibility
Study First Received:	May 21, 2009
Last Updated:	November 8, 2011
Health Authority:	United States: Food and Drug Administration; Poland: Ministry of Health; China: Ethics Committee

Keywords provided by Respicardia, Inc.:

Sleep Disordered Breathing
Periodic Breathing
Cheyne-Stokes Respiration
Sleep Apnea

Additional relevant MeSH terms:

Apnea
Respiratory Aspiration
Cheyne-Stokes Respiration
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases

Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on February 09, 2012