Auditory Processing DisorderNCT00167128
The Phonak EduLink-System in Students With Specific Performance Deficits in Speech-in-Noise Intelligibility
A study testing hearing aid, Phonak EduLink-FM System in people with Auditory Processing Disorder, run by University Hospital Muenster at 2 sites in 2 countries.
Trial summary
In the management and remediation of students with specific performance deficits in speech-in-noise intelligibility, most often, a "triad" approach for treatment is used, which includes direct therapy, compensatory strategies, and environmental modifications. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Auditory Processing Disorder
- What is being tested?
- hearing aid, Phonak EduLink-FM System
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Mar 2005to not given
- 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 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of specific performance deficits in speech-in-noise intelligibility based on two or more standardized tests of auditory processing in noise including retests.
- Students in the 1st to 4th class of primary school
Who cannot join
- Hearing loss, defined as:
- Air conduction pure tone thresholds (250-8000 Hz) exceeding 20 dBHL
- Air-bone gaps, even in the presence of normal sensitivity, exceeding 10 dBHL
- Abnormal tympanogram
- History or diagnosis of behavioral and/or emotional disorders meeting ICD-GM-criteria (including attention deficit/hyperactivity disorders (AD-/HD)
- Non-German speaking
Show all 9Show fewer
- Cognitively impaired children (IQ < 85)
- Children currently using psychoactive medication
- Students with special education
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Germany1 site, 1 recruiting
- Recruiting
Department of Phoniatrics and Pediatric Audiology, University Hospital Münster
Münster, 48149
Peter Matulat, +49(0)251 83 ext. 56898, matulat@uni-muenster.de
Antoinette G Dinnesen, Prof. Dr., +49(0)251 83 ext. 56859, a.g.dinnesen@uni-muenster.de
Switzerland1 site, 1 recruiting
- Recruiting
Phonak AG
Stäfa, 8712
Jürgen Tchorz, Dr, +41 1928 ext. 0101, juergen.tchorz@phonak.ch
About this study
In the management and remediation of students with specific performance deficits in speech-in-noise intelligibility, most often, a "triad" approach for treatment is used, which includes direct therapy, compensatory strategies, and environmental modifications.
The purpose of the study is to determine whether a new hearing aid, the Phonak EduLink-FM System, can improve specific performance deficits in speech-in-noise intelligibility. Participants will complete a test battery related to auditory processing, as well as some psychological tests and questionnaires. One group of participants with specific performance deficits in speech-in-noise intelligibility will receive the hearing aid for use in school; a second group will not. The effect of this treatment on auditory performance, school performance and satisfaction, attention and verbal learning and memory, self concept, behavior and listening effort following 26 weeks of hearing aid use will be compared across the groups.
- Conditions
- Auditory Processing Disorder
- Being tested
- hearing aid, Phonak EduLink-FM System
- Keywords
- Auditory Processing Disorder, speech-in-noise intelligibility
- Medical subject headings
- Auditory Perceptual Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hearing aid, Phonak EduLink-FM SystemDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
auditory performance
Measured: following 26 weeks hearing aid use
school performance and satisfaction
Measured: following 26 weeks hearing aid use
attention
Measured: following 26 weeks hearing aid use
verbal learning and memory
Measured: following 26 weeks hearing aid use
Secondary outcomes (3)
self concept
Measured: following 26 weeks hearing aid use
behavior
Measured: following 26 weeks hearing aid use
listening effort
Measured: following 26 weeks hearing aid use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Auditory Processing DisorderStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Collaborators
- Phonak AG, Switzerland
- Investigators
- Peter Matulat, Principal investigator, Department of Phoniatrics and Pediatric Audiology, University Hospital MünsterAntoinette G Dinnesen, Prof. Dr., Study director, Department of Phoniatrics and Pediatric Audiology, University Hospital Münster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00167128
- Sponsor's protocol ID
- phonpaed002
- Status last verified
- May 2006
- First submitted
- 12 Sep 2005
- Last updated
- 15 Aug 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Phonak EduLink-System in Students With Specific Performance Deficits in Speech-in-Noise Intelligibility
- ClinicalTrials.gov ID
- NCT00167128
- Acronym / sponsor ID
- phonpaed002
- Conditions
- Auditory Processing Disorder
- Keywords
- Auditory Processing Disorder, speech-in-noise intelligibility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Collaborators
- Phonak AG, Switzerland
- Study start
- Mar 2005
- First posted
- 14 Sep 2005 (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.
In the management and remediation of students with specific performance deficits in speech-in-noise intelligibility, most often, a "triad" approach for treatment is used, which includes direct therapy, compensatory strategies, and environmental modifications.
The purpose of the study is to determine whether a new hearing aid, the Phonak EduLink-FM System, can improve specific performance deficits in speech-in-noise intelligibility. Participants will complete a test battery related to auditory processing, as well as some psychological tests and questionnaires. One group of participants with specific performance deficits in speech-in-noise intelligibility will receive the hearing aid for use in school; a second group will not. The effect of this treatment on auditory performance, school performance and satisfaction, attention and verbal learning and memory, self concept, behavior and listening effort following 26 weeks of hearing aid use will be compared across the groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Diagnosis of specific performance deficits in speech-in-noise intelligibility based on two or more standardized tests of auditory processing in noise including retests.
- Students in the 1st to 4th class of primary school
Key exclusion criteria (9 listed)
- Hearing loss, defined as:
- History or diagnosis of behavioral and/or emotional disorders meeting ICD-GM-criteria (including attention deficit/hyperactivity disorders (AD-/HD)
- Non-German speaking
- Cognitively impaired children (IQ < 85)
- Children currently using psychoactive medication
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 |
|---|---|---|
| hearing aid, Phonak EduLink-FM System | Device | – |
Primary outcome
auditory performance
Time frame: following 26 weeks hearing aid use
school performance and satisfaction
Time frame: following 26 weeks hearing aid use
attention
Time frame: following 26 weeks hearing aid use
verbal learning and memory
Time frame: following 26 weeks hearing aid use
3 secondary outcomes
self concept
Time frame: following 26 weeks hearing aid use
behavior
Time frame: following 26 weeks hearing aid use
listening effort
Time frame: following 26 weeks hearing aid use
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2007.
Related trials for Auditory Processing Disorder
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BiOfeedback, Online for Sibilant Treatment
Speech Sound Disorder
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Online Rotating Delivery of Perception/Production Enhanced Treatment for Rhotics
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Recruiting
Listening Effort in Cochlear Implant Users
Auditory Perception; Abnormal, Hearing Loss, Sensorineural
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.
Peter Matulat principal investigator
Department of Phoniatrics and Pediatric Audiology, University Hospital Münster
Antoinette G Dinnesen, Prof. Dr. study director
Department of Phoniatrics and Pediatric Audiology, University Hospital Münster
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hearing aid, Phonak EduLink-FM System in people with Auditory Processing Disorder, run by University Hospital Muenster at 2 sites in 2 countries.
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 2 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 15 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter Matulat (+49(0)251 83 ext. 56898, matulat@uni-muenster.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
auditory performance (time frame: following 26 weeks hearing aid use). The study lists 4 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 15 Aug 2007.