Feasibility Study to Determine the Effects of Phrenic Nerve Stimulation in Patients With Periodic Breathing - NCT00909259- (Clinical Trial 295286)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy295286.aspx
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Columbus |
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State:
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OH |
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| Conditions: |
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Sleep Disordered Breathing - Cheyne-Stokes Respiration - Sleep Apnea |
| Purpose: |
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The purpose of this feasibility study is to determine the effect of phrenic nerve
stimulation on 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.
The study is acute in nature, such that subjects will undergo the placement of a stimulation
lead, followed by assessment of phrenic stimulation 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.
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 chronic study.
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| Study summary: |
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| Criteria: |
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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). |
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| Study is available at: |
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The Ohio State University
Columbus, OH
United States
Primary Contact:
Susan Petersen-Stejskal, RN
Email: spetersen-stejskal@cardiacconcepts.com |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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