Status:
COMPLETED
Feasibility Study to Determine the Effects of Phrenic Nerve Stimulation in Patients With Periodic Breathing
Lead Sponsor:
Respicardia, Inc.
Conditions:
Sleep Disordered Breathing
Cheyne-Stokes Respiration
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2013
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00909259
Start Date
October 1 2007
End Date
December 1 2013
Last Update
January 6 2014
Active Locations (5)
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1
Hennepin County Medical Center
Minneapolis, Minnesota, United States
2
Ohio Heart Hospital
Cincinnati, Ohio, United States
3
The Ohio State University
Columbus, Ohio, United States
4
Jiangsu Province Hospital
Nanjing, China