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Relationship Between Auto NRT and Behavioural T & C Levels With the Nucleus Freedom Cochlear Implant

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ClinicalTrials.gov Identifier: NCT00331539
Recruitment Status : Unknown
Verified July 2005 by Bnai Zion Medical Center.
Recruitment status was:  Recruiting
First Posted : May 31, 2006
Last Update Posted : October 9, 2006
Sponsor:
Information provided by:
Bnai Zion Medical Center

Brief Summary:
Cochlear implants require programming on an individual basis to provide appropriate levels of electrical stimulation. This program, or "map", is placed in the speech processor of the cochlear implant. Success of implantation largely depends on the adequacy of this map. Cochlear implant fitting remains a difficult challenge in congenitally or pre-linguistically deafened children. It requires competence of experienced audiologists with expertise in behavioral techniques for hearing function assessment.Our goal is to establish the offset correlation between objective measurements (NRT and ESRT) and the behavioral measurements of T & Cs in different stimulation rates in the Freedom SP System.

Condition or disease Intervention/treatment Phase
Hearing Loss Device: Cochlear Implant Phase 4

Detailed Description:
An open trail. The implantees will go through their routine programming sessions after implantation, the specified data will be collected and analyzed in order to establish the offset correlation which we seek for.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Relationship Between Auto NRT and Behavioural T & C Levels With the Nucleus Freedom Cochlear Implant
Study Start Date : May 2006
Study Completion Date : June 2008

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Primary Outcome Measures :
  1. To find possible correlation between behavioral counted T & C levels at different stimulation rates and NRT thresholds using the Auto NRT and ESRT over time, from switch on up to 12 months period.
  2. To find possible changes over time in NRT thresholds (12 months period).
  3. To find possible changes over time in ESRT thresholds (9 months period) starting 3 months post-op.


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:Patients eligible for the study should be capable of providing reliable subjective counted thresholds (e.g. children older than 12 years of age at CI or adults) and has good NRT recordings, implanted with the Nucleus Freedom system

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Exclusion Criteria:Implantees With any other serious illness, Who can not give a reliable subjective counted thresholds

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00331539


Contacts
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Contact: Michal Luntz, MD 972-4-8359544 michal.luntz@b-zion.org.il
Contact: Talma Shpak, MA 972-4-8359830 thalma@netvision.net.il

Locations
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Israel
Bnai Zion MC Recruiting
Haifa, Israel, 31048
Contact: Michal Luntz, MD    972-4-8359544    michal.luntz@b-zion.org.il   
Principal Investigator: Michal Luntz, MD         
Sponsors and Collaborators
Bnai Zion Medical Center
Investigators
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Principal Investigator: Michal Luntz, MD Head of the E.N.T department head and neck surgery Bnai Zion MC ISRAEL

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ClinicalTrials.gov Identifier: NCT00331539     History of Changes
Other Study ID Numbers: BnaiZionMC-06-ML-002-CTIL
First Posted: May 31, 2006    Key Record Dates
Last Update Posted: October 9, 2006
Last Verified: July 2005

Keywords provided by Bnai Zion Medical Center:
Cochlear implant
threshold (T) measurement
comfort (C) level
profound hearing loss
auditory stimuli
profound hearing loss patients eligible for the study should be capable of providing reliable
subjective counted thresholds and has good NRT recordings, implanted with
the Nucleus Freedom system

Additional relevant MeSH terms:
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Hearing Loss
Deafness
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms