Back to resultsRelationship Between Auto NRT and Behavioural T & C Levels With the Nucleus Freedom Cochlear Implant
Primary Purpose
Hearing Loss
Status
Unknown status
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Cochlear Implant
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Loss focused on measuring 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
Eligibility 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 - Exclusion Criteria:Implantees With any other serious illness, Who can not give a reliable subjective counted thresholds -
Sites / Locations
- Bnai Zion MCRecruiting
Outcomes
Primary Outcome Measures
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.
To find possible changes over time in NRT thresholds (12 months period).
To find possible changes over time in ESRT thresholds (9 months period) starting 3 months post-op.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00331539
Brief Title
Relationship Between Auto NRT and Behavioural T & C Levels With the Nucleus Freedom Cochlear Implant
Official Title
Relationship Between Auto NRT and Behavioural T & C Levels With the Nucleus Freedom Cochlear Implant
Study Type
Interventional
2. Study Status
Record Verification Date
July 2005
Overall Recruitment Status
Unknown status
Study Start Date
May 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2008 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Bnai Zion Medical Center
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
Keywords
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Cochlear Implant
Primary Outcome Measure Information:
Title
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.
Title
To find possible changes over time in NRT thresholds (12 months period).
Title
To find possible changes over time in ESRT thresholds (9 months period) starting 3 months post-op.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
-
Exclusion Criteria:Implantees With any other serious illness, Who can not give a reliable subjective counted thresholds
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michal Luntz, MD
Phone
972-4-8359544
Email
michal.luntz@b-zion.org.il
First Name & Middle Initial & Last Name or Official Title & Degree
Talma Shpak, MA
Phone
972-4-8359830
Email
thalma@netvision.net.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michal Luntz, MD
Organizational Affiliation
Head of the E.N.T department head and neck surgery Bnai Zion MC ISRAEL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bnai Zion MC
City
Haifa
ZIP/Postal Code
31048
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michal Luntz, MD
Phone
972-4-8359544
Email
michal.luntz@b-zion.org.il
First Name & Middle Initial & Last Name & Degree
Michal Luntz, MD
12. IPD Sharing Statement
Learn more about this trial
Relationship Between Auto NRT and Behavioural T & C Levels With the Nucleus Freedom Cochlear Implant
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