Safety Study to Evaluate the Effect of Lowering Body Temperature During Cochlear Implantation

Stopped early · Phase 2

Conditions studied: Hypothermia

In brief

Hypothesis: Mild Hypothermia has a protective effect on residual hearing of patients undergoing cochlear implantation

Key facts

Study ID

NCT00375882

Run by

University of Miami

People needed

19

Starts

2006-03-01

Expected to finish

2010-02-01

Last updated by the study team

2014-08-15

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults undergoing measurable auditory function who are undergoing cochlear implantation as routine management of severe to profound hearing loss.

You may not qualify if…

• 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

Where it is running

• University of Miami, Miller School of Medicine, Ear Institute — Miami, Florida, United States

Full record on ClinicalTrials.gov

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