The Phonak EduLink-System in Students With Specific Performance Deficits in Speech-in-Noise Intelligibility

U

University Hospital Muenster

Status

Unknown

Conditions

Auditory Processing Disorder

Treatments

Device: hearing aid, Phonak EduLink-FM System

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00167128
phonpaed002

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

6 to 11 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

2

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Central trial contact

Antoinette G Dinnesen, Prof. Dr.; Peter Matulat

Data sourced from clinicaltrials.gov

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