Feasibility Study to Determine the Effects of Phrenic Nerve Stimulation in Patients With Periodic Breathing
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.
Sleep Disordered Breathing
Device: Phrenic stimulation device
|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|
- 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 ]
- Characterization of chronic safety of stimulating the phrenic nerve (Stage 2 of study). [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2007|
|Study Completion Date:||December 2013|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00909259
|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|
|Polish Military Hospital|