Cochlear ImplantNCT01737489
Title: "Development and Implementation of Innovative Auditory Training Methods and Verification of These Training Methods"
A study testing LACE and NOOK in people with Cochlear Implant, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to determine if aural rehabilitation adds measurable benefit and participant satisfaction to a cochlear implant recipient's overall treatment. Also, the study is designed to compare the efficacy of a commercially available aural rehabilitation program (LACE) and an electronic program which… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Cochlear Implant
- What is being tested?
- LACE and NOOK
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Aug 2015
- Phase
- Interventional
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Criteria for Inclusion:
- Willingness to participate
- Ability to provide informed written consent
- Willingness to follow study protocol
- Eighteen years or older at the time of signing the consent form
- Cochlear implant experience for 12 months or greater
- Spoken English as the first language
- Access to a home computer which meets the minimal requirements to run appropriate program or the ability to use an electronic reader depending on which group the participant is assigned to.
- Reports being comfortable using a computer if in the LACE group
Criteria for Exclusion:
- Unable or unwillingness to sign informed written consent
- Unable or unwillingness to follow study protocol
- Non-English speaking or English as a second language
- No access to a computer if assigned to the LACE study group
- Reports not being comfortable using a computer if assigned to the LACE study group.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
The purpose of this study is to determine if aural rehabilitation adds measurable benefit and participant satisfaction to a cochlear implant recipient's overall treatment. Also, the study is designed to compare the efficacy of a commercially available aural rehabilitation program (LACE) and an electronic program which takes advantage of a traditional form of auditory training (NOOK) for cochlear implant users.
Read the detailed description
The primary objective of this study is to determine if aural rehabilitation adds measurable benefit and participant satisfaction to a cochlear implant recipient's overall treatment.
The secondary objective of this study is to compare the efficacy of a commercially available aural rehabilitation program (LACE) and an electronic program which takes advantage of a traditional form of auditory training (NOOK) for cochlear implant users.
- Conditions
- Cochlear Implant
- Being tested
- LACE, NOOK
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LACEBehavioural
commercially available LACE program which is administered by computer as daily lessons. The participants will do this program for one month
NOOKBehavioural
will use an electronic reader (Barnes and Noble - NOOK device) to do speech tracking.will do this activity for approximately one hour per day for five days out of seven for a total of four weeks. The speech tracking activity will involve reading approximately two books within the one month time frame. The participants will listen to the book while reading an unabridged book in printed form.
| Study group | Role | What they receive |
|---|---|---|
| LACE ( Listening And Communication Enhancement ) | Active comparator | use the commercially available auditory training program which is administered by computer as daily lessons. Receives: Behavioral: LACE |
| NOOK (Electronic reader) | Active comparator | will use an electronic reader (NOOK device) to do speech tracking Receives: Behavioral: NOOK |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Word recognition
Word recognition will be measured using the Consonant Nucleus Consonant (CNC) Test, a 50 word open set test.
Measured: baseline to 6 months
Signal-to-noise ratio
The signal to noise ratio will be measured using the Bamford-Kowal-Bench (BKB) test.
Measured: baseline to 6 months
Secondary outcomes (1)
Percent of speech comprehension
Percent of speech comprehension will be measured by the AzBio Sentence Lists, which were created at Arizona State University and evaluate speech understanding.
Measured: baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cochlear ImplantStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Annamary (Ann) Peterson, Mayo Clinic
- Investigators
- Annamary Peterson, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01737489
- Sponsor's protocol ID
- 12-007641
- Status last verified
- Sep 2017
- First submitted
- 27 Nov 2012
- Last updated
- 8 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Title: "Development and Implementation of Innovative Auditory Training Methods and Verification of These Training Methods"
- ClinicalTrials.gov ID
- NCT01737489
- Acronym / sponsor ID
- 12-007641
- Conditions
- Cochlear Implant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 29 Nov 2012 (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.
The purpose of this study is to determine if aural rehabilitation adds measurable benefit and participant satisfaction to a cochlear implant recipient's overall treatment. Also, the study is designed to compare the efficacy of a commercially available aural rehabilitation program (LACE) and an electronic program which takes advantage of a traditional form of auditory training (NOOK) for cochlear implant users.
Detailed description
The primary objective of this study is to determine if aural rehabilitation adds measurable benefit and participant satisfaction to a cochlear implant recipient's overall treatment.
The secondary objective of this study is to compare the efficacy of a commercially available aural rehabilitation program (LACE) and an electronic program which takes advantage of a traditional form of auditory training (NOOK) for cochlear implant users.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LACE ( Listening And Communication Enhancement ) | Active comparator | Behavioral: LACEuse the commercially available auditory training program which is administered by computer as daily lessons. |
| NOOK (Electronic reader) | Active comparator | Behavioral: NOOKwill use an electronic reader (NOOK device) to do speech tracking |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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 |
|---|---|---|
| LACEcommercially available LACE program which is administered by computer as daily lessons. The participants will do this program for one month | Behavioural | LACE ( Listening And Communication Enhancement ) |
| NOOKwill use an electronic reader (Barnes and Noble - NOOK device) to do speech tracking.will do this activity for approximately one hour per day for five days out of seven for a total of four weeks. The speech tracking activity will involve reading approximately two books within the one month time frame. The participants will listen to the book while reading an unabridged book in printed form. | Behavioural | NOOK (Electronic reader) |
Primary outcome
Word recognition
Time frame: baseline to 6 months
Word recognition will be measured using the Consonant Nucleus Consonant (CNC) Test, a 50 word open set test.
Signal-to-noise ratio
Time frame: baseline to 6 months
The signal to noise ratio will be measured using the Bamford-Kowal-Bench (BKB) test.
1 secondary outcome
Percent of speech comprehension
Time frame: baseline to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2017.
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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.
Annamary Peterson principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LACE and NOOK in people with Cochlear Implant, run by Mayo Clinic at 1 site in United States.
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: finished, as of the sponsor's last update on 8 Sep 2017. 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 United States. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Word recognition (time frame: baseline to 6 months). The study lists 2 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 8 Sep 2017; AzTrials last refreshed its copy on 5 Nov 2026.