Clinical trial NCT00167128: The Phonak EduLink-System in Students With Specific Performance Deficits in Speech-in-Noise Intelligibility
Official title: The Phonak EduLink-System in Students With Specific Performance Deficits in Speech-in-Noise Intelligibility
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Auditory Processing Disorder
Keywords: Auditory Processing Disorder
speech-in-noise intelligibility
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
Collaborators: name: Phonak AG, Switzerland
First posted: 2005-09-14
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* Cognitively impaired children (IQ \< 85)
* Children currently using psychoactive medication
* Students with special education

Primary outcomes:
measure: auditory performance
timeFrame: following 26 weeks hearing aid use
measure: school performance and satisfaction
timeFrame: following 26 weeks hearing aid use
measure: attention
timeFrame: following 26 weeks hearing aid use
measure: verbal learning and memory
timeFrame: following 26 weeks hearing aid use
Secondary outcomes:
measure: self concept
timeFrame: following 26 weeks hearing aid use
measure: behavior
timeFrame: following 26 weeks hearing aid use
measure: listening effort
timeFrame: following 26 weeks hearing aid use
Other outcomes:
Locations:
city: Münster
country: Germany
facility: Department of Phoniatrics and Pediatric Audiology, University Hospital Münster
city: Stäfa
country: Switzerland
facility: Phonak AG
Study officials:
affiliation: Department of Phoniatrics and Pediatric Audiology, University Hospital Münster
name: Peter Matulat
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Phoniatrics and Pediatric Audiology, University Hospital Münster
name: Antoinette G Dinnesen, Prof. Dr.
role: STUDY_DIRECTOR
References: