Clinical Trial: Feasibility Study to Determine the Effects of Phrenic Nerve Stimulation in Patients With Periodic Breathing
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: 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 Summary:
Sponsor: Respicardia, Inc.
Current Primary Outcome:
- 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: Same as current
Current Secondary Outcome: Characterization of chronic safety of stimulating the phrenic nerve (Stage 2 of study). [ Time Frame: 2 years ]
Original Secondary Outcome:
Information By: Respicardia, Inc.
Dates:
Date Received: May 21, 2009
Date Started: October 2007
Date Completion:
Last Updated: January 2, 2014
Last Verified: January 2014
