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

NCT ID: NCT00167128

Last Updated: 2007-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Auditory Processing Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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hearing aid, Phonak EduLink-FM System

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Phonak AG, Switzerland

INDUSTRY

Sponsor Role collaborator

University Hospital Muenster

OTHER

Sponsor Role lead

Principal Investigators

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Peter Matulat

Role: PRINCIPAL_INVESTIGATOR

Department of Phoniatrics and Pediatric Audiology, University Hospital Münster

Antoinette G Dinnesen, Prof. Dr.

Role: STUDY_DIRECTOR

Department of Phoniatrics and Pediatric Audiology, University Hospital Münster

Locations

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Department of Phoniatrics and Pediatric Audiology, University Hospital Münster

Münster, , Germany

Site Status RECRUITING

Phonak AG

Stäfa, , Switzerland

Site Status RECRUITING

Countries

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Germany Switzerland

Central Contacts

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Peter Matulat

Role: CONTACT

+49(0)251 83 ext. 56898

Antoinette G Dinnesen, Prof. Dr.

Role: CONTACT

+49(0)251 83 ext. 56859

Facility Contacts

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Peter Matulat

Role: primary

+49(0)251 83 ext. 56898

Antoinette G Dinnesen, Prof. Dr.

Role: backup

+49(0)251 83 ext. 56859

Jürgen Tchorz, Dr

Role: primary

+41 1928 ext. 0101

Other Identifiers

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phonpaed002

Identifier Type: -

Identifier Source: org_study_id