Hearing LossPhase 4NCT00331539
Relationship Between Auto NRT and Behavioural T & C Levels With the Nucleus Freedom Cochlear Implant
A Phase 4 study testing Cochlear Implant in people with Hearing Loss, run by Bnai Zion Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Cochlear Implant
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- May 2006to Jun 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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
-
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Bnai Zion MC
Haifa, 31048
Michal Luntz, MD, 972-4-8359544, michal.luntz@b-zion.org.il
Michal Luntz, MD
About this study
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.
Read the 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.
- Conditions
- Hearing Loss
- Being tested
- Cochlear Implant
- 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
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cochlear ImplantDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2006 (estimated)
- Study startMay 2006
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Bnai Zion Medical Center
- Sponsor type
- Other government
- Investigators
- Michal Luntz, MD, Principal investigator, Head of the E.N.T department head and neck surgery Bnai Zion MC ISRAEL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00331539
- Sponsor's protocol ID
- BnaiZionMC-06-ML-002-CTIL
- Status last verified
- Jul 2005
- First submitted
- 30 May 2006
- Last updated
- 9 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Auto NRT and Behavioural T & C Levels With the Nucleus Freedom Cochlear Implant
- ClinicalTrials.gov ID
- NCT00331539
- Acronym / sponsor ID
- BnaiZionMC-06-ML-002-CTIL
- Conditions
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants
- Lead sponsor
- Bnai Zion Medical CenterOther government
- Study start
- May 2006
- Study completion
- Jun 2008
- First posted
- 31 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cochlear Implant | Device | – |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2006.
Related trials for Hearing Loss
Not yet recruiting
Automated Text Message Reminders to Promote Hearing Aid Adoption
Hearing Loss
Enrolling by invitationObservational study
Post-Market Registry Study for Vibrant Hearing Solutions
Conductive Hearing Loss, Mixed Hearing Loss
Recruiting
Investigating Auditory Processing in the Users of Auditory Brainstem and Cochlear Implants
Deafness
RecruitingObservational study
Collection of Clinical Data and Specimens for Research in Hearing, Balance, Taste, Smell, Voice, Speech, and Language Disorders.
Hearing Loss, Deafness
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michal Luntz, MD principal investigator
Head of the E.N.T department head and neck surgery Bnai Zion MC ISRAEL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cochlear Implant in people with Hearing Loss, run by Bnai Zion Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michal Luntz, MD (972-4-8359544, michal.luntz@b-zion.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2006.