Hearing LossLittlEarsNCT00785707
Littlears Auditory Questionnaire: Validation Study in CI Children
An observational study of Hearing Loss, run by Med-El Corporation at 5 sites in United States.
Trial summary
The LittlEARS Auditory Questionnaire is designed to assess the development of the auditory behavior in children during the first two (hearing) years. The questionnaire has been validated on children with normal hearing whose native language is German. Read more about this study
- Who is it for?
- Ages Up to 24 months
- Conditions the study is for
- Hearing Loss
- How many people
- 31 participants
- Where
- 5 sitesUnited States
- Study dates
- May 2008to Feb 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Up to 24 months
- All sexes
- No healthy volunteers
- Child
Study population: Children under the age of 24 months at time of cochlear implantation recommended by the cochlear implant clinic.
Who may be able to join
- General:
- Less than or 24 months of age prior to implantation
- Cochlear implant candidate deemed by the clinic
- To be implanted with a MED-EL cochlear implant PULSARCI100 or SONATATI100
- English as the primary language at home
- Realistic expectations of guardians
Show all 10Show fewer
- Willing and available to comply with all scheduled procedures as defined in the protocol
- Medical:
- Good general health status, as judged by Primary Investigator
- No contraindications for surgery, in general, or cochlear implant surgery in particular
Who cannot join
- General:
- Prior experience with any cochlear implant system
- Older than 24 months at time of implantation
- Medical:
- Severed or non-functional auditory nerve in the ear(s) to be implanted
- Cognitive and/or neurological dysfunction
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Georgia Health Sciences University
Augusta, Georgia, 30912
University of North Carolina-Chapel Hill/CCCDP
Durham, North Carolina, 27713
Cook Children's Medical Center
Fort Worth, Texas, 76104
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Vanderbilt University
Nashville, Tennessee, 37232
About this study
Official title: Littlears Auditory Questionnaire Validation Study in CI Children With LittlEARS My Diary: Language: North American English
The LittlEARS Auditory Questionnaire is designed to assess the development of the auditory behavior in children during the first two (hearing) years. The questionnaire has been validated on children with normal hearing whose native language is German. A comparison was made between North American English speaking children with normal hearing and found that it was consistent with the German data. This study is to validate the questionnaire in children with cochlear implants.
- Conditions
- Hearing Loss
- Keywords
- sensorineural hearing loss, cochlear implant
- Medical subject headings
- Hearing Loss, Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| cochlear implant | children less than 24 months at time of cochlear implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Validate the LittleEARS Auditory Questionnaire
The LittleEARS auditory questionnaire (LEAQ) uses parent responses to assess auditory behavior in children up to 24 months of age. The questionnaire is scored from 0 to 35 with 0 indicating poorer performance and 35 indicating better performance. There are no subscales for the questionnaire.
Measured: 24 months
Secondary outcomes (1)
Change in LEAQ Scale Score of Cochlear Implanted Children Over 24 Months After First CI Fitting
The LittleEARS auditory questionnaire (LEAQ) uses parent responses to assess auditory behavior in children up to 24 months of age. The questionnaire is scored from 0 to 35 with 0 indicating poorer performance and 35 indicating better performance. There are no subscales for the questionnaire. This outcome measure is reported as a change on the LEAQ scale from initial CI fitting to 24 months.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2008 (estimated)
- Study startMay 2008
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Med-El Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00785707
- Sponsor's protocol ID
- MED-EL NA 020
- Acronym
- LittlEars
- Status last verified
- Apr 2017
- First submitted
- 4 Nov 2008
- Last updated
- 26 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Fisseni HJ. (1998) Lehrbuch der psychologischen Diagnostik, Göttingen, Hogrefe.
Kühn-Inacker H, Weichbold V, Tsaikpini L, Coninx F, D'Hease P. (2003) LittlEARS Hörfragebogen - Handanweisung. MED-EL Headquarters, Innsbruck, Austria.
Weichbold V, Tsiakpini L, Coninx F, D'Haese P. [Development of a parent questionnaire for assessment of auditory behaviour of infants up to two years of age]. Laryngorhinootologie. 2005 May;84(5):328-34. doi: 10.1055/s-2004-826232. German.
PubMed 15909244
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Littlears Auditory Questionnaire Validation Study in CI Children With LittlEARS My Diary: Language: North American English
- ClinicalTrials.gov ID
- NCT00785707
- Acronym / sponsor ID
- LittlEars / MED-EL NA 020
- Conditions
- Hearing Loss
- Keywords
- sensorineural hearing loss, cochlear implant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Med-El CorporationIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 5 Nov 2008 (estimated)
- Results
- Posted 26 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The LittlEARS Auditory Questionnaire is designed to assess the development of the auditory behavior in children during the first two (hearing) years. The questionnaire has been validated on children with normal hearing whose native language is German. A comparison was made between North American English speaking children with normal hearing and found that it was consistent with the German data. This study is to validate the questionnaire in children with cochlear implants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cochlear implant | – | –children less than 24 months at time of cochlear implantation |
Who may qualify
- Ages
- Up to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children under the age of 24 months at time of cochlear implantation recommended by the cochlear implant clinic.
Key inclusion criteria (10 listed)
- Less than or 24 months of age prior to implantation
- Cochlear implant candidate deemed by the clinic
- To be implanted with a MED-EL cochlear implant PULSARCI100 or SONATATI100
- English as the primary language at home
- Realistic expectations of guardians
Key exclusion criteria (6 listed)
- Prior experience with any cochlear implant system
- Older than 24 months at time of implantation
- Severed or non-functional auditory nerve in the ear(s) to be implanted
- Cognitive and/or neurological dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To Validate the LittleEARS Auditory Questionnaire
Time frame: 24 months
The LittleEARS auditory questionnaire (LEAQ) uses parent responses to assess auditory behavior in children up to 24 months of age. The questionnaire is scored from 0 to 35 with 0 indicating poorer performance and 35 indicating better performance. There are no subscales for the questionnaire.
1 secondary outcome
Change in LEAQ Scale Score of Cochlear Implanted Children Over 24 Months After First CI Fitting
Time frame: 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundFisseni HJ. (1998) Lehrbuch der psychologischen Diagnostik, Göttingen, Hogrefe.
- BackgroundKühn-Inacker H, Weichbold V, Tsaikpini L, Coninx F, D'Hease P. (2003) LittlEARS Hörfragebogen - Handanweisung. MED-EL Headquarters, Innsbruck, Austria.
- Background: PubMed 15909244Weichbold V, Tsiakpini L, Coninx F, D'Haese P. [Development of a parent questionnaire for assessment of auditory behaviour of infants up to two years of age]. Laryngorhinootologie. 2005 May;84(5):328-34. doi: 10.1055/s-2004-826232. German.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Loss, run by Med-El Corporation at 5 sites 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?
The sponsor lists 10 inclusion and 6 exclusion criteria. 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 26 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Yes. Results are posted in the registry (first posted 26 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
To Validate the LittleEARS Auditory Questionnaire (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00785707, which also lists 3 linked publications.
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 26 Jun 2017.