Sleep Apnea Clinical Trial
Official title:
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.
n/a
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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