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

Primary Purpose

Hypothermia

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
hypothermia
cochlear implantation with mild hypothermia
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypothermia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • University of Miami, Miller School of Medicine, Ear Institute

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

cochlear implantation with mild hypothermia

Arm Description

Outcomes

Primary Outcome Measures

To determine if mild hypothermia has a protective effect on residual hearing of patients undergoing cochlear implantation.

Secondary Outcome Measures

To determine if mild hypothermia has a protective effect on residual hearing of patients undergoing cochlear implantation

Full Information

First Posted
September 11, 2006
Last Updated
August 14, 2014
Sponsor
University of Miami
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1. Study Identification

Unique Protocol Identification Number
NCT00375882
Brief Title
Safety Study to Evaluate the Effect of Lowering Body Temperature During Cochlear Implantation
Official Title
Mild Hypothermia During Cochlear Implantation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Terminated
Why Stopped
as specified in the protocol
Study Start Date
March 2006 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Miami

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 hypothermia on auditory function caused by cochlear implant electrodes in animal models. Preservation of residual hearing of patients undergoing cochlear implantation is highly desirable and based on these animal studies, it may be possible to achieve in human subjects using mild degrees of hypothermia. We propose to investigate the hypothesized protective effect of intra-operative hypothermia on adult subjects undergoing cochlear implantation. Inclusion Criteria: Adults greater than or equal to 18 years of age with some measurable auditory function who are undergoing cochlear implantation as routine management of severe to profound hearing loss. Exclusion Criteria: Pure tone average hearing (mean of .5, 1 and 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. Phase I: Up to 40 healthy adult subjects who have qualified for CI will undergo implantation with core body temperature lowered to 34 degree Centigrade for approximately one hour before electrode insertion and 30 minutes after insertion. Otherwise, the surgical technique will be unchanged from our standard procedure. The heating/cooling blanket is an FDA approved device. similar temperature controlling blankets are used in virtually all operations done under general anesthesia. Each subject's temperature will be gradually lowered only after they are put to sleep. Warming will being at least 30 minutes before the subject is awakened. We will measure and record the subject's temperature every 5 to 15 minutes while they are in the operating room and also while they are in the recovery room. Each subject will undergo a battery of audiometric tests (CNC words, HINT sentences, pure tone thresholds, and immittance) within one month prior to implantation, at one month post operatively, at 6 months post operatively and 1 year postoperatively. Outcomes will be analyzed by PI after 10 subjects have completed the 1 month test interval. If outcomes indicate proof of principle (measurable pure tone responses in greater than or equal to 60% of subjects), phase two of the study will be initiated. If not, outcomes will be analyzed after 20, 30, and 40 subjects until evidence of hearing conservation or lack of it is established, leading to the following study or precluding it. Phase II: Up to 80 healthy adults who have qualified for CI will be randomized into control group (CI surgery using standard procedure at core body temperature of 37 degree C) or active group (identical core body temperature of 34 degrees C). Subjects will be randomized using a random table of numbers. The patient, surgeon and audiologist will be blinded to the group assignment. Only the study coordinator will have the sequestered and locked list of randomization and blinding. Only the anesthesiologist will know the patients' assignment at the time of surgery. The audiologist will not be present in the O.R. or in the outpatient clinic, but will only test the patient post surgery. Each subject will undergo a battery of audiometric tests (CNC words, HINT sentences, pure tone thresholds, and immittance) just prior to implantation, at 1 month post operatively, at 6 months post operatively and at 1 year postoperatively.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothermia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cochlear implantation with mild hypothermia
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
hypothermia
Intervention Type
Procedure
Intervention Name(s)
cochlear implantation with mild hypothermia
Primary Outcome Measure Information:
Title
To determine if mild hypothermia has a protective effect on residual hearing of patients undergoing cochlear implantation.
Time Frame
one month post cochlear implantation
Secondary Outcome Measure Information:
Title
To determine if mild hypothermia has a protective effect on residual hearing of patients undergoing cochlear implantation
Time Frame
one year post cochlear implantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults undergoing measurable auditory function who are undergoing cochlear implantation as routine management of severe to profound hearing loss. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas J Balkany, M.D.
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami, Miller School of Medicine, Ear Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

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

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