NCT00375882

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2006

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 13, 2006

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

August 15, 2014

Status Verified

August 1, 2014

Enrollment Period

3.9 years

First QC Date

September 11, 2006

Last Update Submit

August 14, 2014

Conditions

Hypothermia

Outcome Measures

Primary Outcomes (1)

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

    one month post cochlear implantation

Secondary Outcomes (1)

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

    one year post cochlear implantation

Study Arms (1)

cochlear implantation with mild hypothermia

OTHER
Procedure: hypothermiaProcedure: cochlear implantation with mild hypothermia

Interventions

hypothermiaPROCEDURE
cochlear implantation with mild hypothermia
cochlear implantation with mild hypothermiaPROCEDURE
cochlear implantation with mild hypothermia

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami, Miller School of Medicine, Ear Institute

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Hypothermia

Interventions

Cochlear Implantation

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Otologic Surgical ProceduresOtorhinolaryngologic Surgical ProceduresSurgical Procedures, OperativeProsthesis Implantation

Study Officials

  • Thomas J Balkany, M.D.

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2006

First Posted

September 13, 2006

Study Start

March 1, 2006

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

August 15, 2014

Record last verified: 2014-08

Locations

US(1)