Status:
TERMINATED
Safety Study to Evaluate the Effect of Lowering Body Temperature During Cochlear Implantation
Lead Sponsor:
University of Miami
Conditions:
Hypothermia
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Hypothesis: Mild Hypothermia has a protective effect on residual hearing of patients undergoing cochlear implantation
Detailed Description
Hypothermia has been shown to have a protective effect following trauma to the central nervous system and the peripheral auditory system. We have previously demonstrated a protective effect of mild hy...
Eligibility Criteria
Inclusion
- Adults undergoing measurable auditory function who are undergoing cochlear implantation as routine management of severe to profound hearing loss.
Exclusion
- Pure tone average hearing ( mean of .5, 1 adn 2 KHz) worse than 100dB
- Age\> 70 years
- History of arrhythmia or ischemic heart disease
- Sickle cell trait or disease
- Immune incompetence; coagulation disorders
- Revision cochlear implant; body-mass index \>35
- Cold related disorders
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00375882
Start Date
March 1 2006
End Date
February 1 2010
Last Update
August 15 2014
Active Locations (1)
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1
University of Miami, Miller School of Medicine, Ear Institute
Miami, Florida, United States, 33136