NCT00167128

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
Last Updated

August 15, 2007

Status Verified

May 1, 2006

First QC Date

September 12, 2005

Last Update Submit

August 14, 2007

Conditions

Auditory Processing Disorder

Keywords

Auditory Processing Disorderspeech-in-noise intelligibility

Outcome Measures

Primary Outcomes (4)

  • auditory performance

    following 26 weeks hearing aid use

  • school performance and satisfaction

    following 26 weeks hearing aid use

  • attention

    following 26 weeks hearing aid use

  • verbal learning and memory

    following 26 weeks hearing aid use

Secondary Outcomes (3)

  • self concept

    following 26 weeks hearing aid use

  • behavior

    following 26 weeks hearing aid use

  • listening effort

    following 26 weeks hearing aid use

Interventions

hearing aid, Phonak EduLink-FM SystemDEVICE

Eligibility Criteria

Age6 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Phoniatrics and Pediatric Audiology, University Hospital Münster

Münster, 48149, Germany

RECRUITING

Phonak AG

Stäfa, 8712, Switzerland

RECRUITING

MeSH Terms

Conditions

Auditory Perceptual Disorders

Interventions

Hearing Aids

Condition Hierarchy (Ancestors)

Auditory Diseases, CentralRetrocochlear DiseasesEar DiseasesOtorhinolaryngologic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsCognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Wearable Electronic DevicesElectrical Equipment and SuppliesEquipment and SuppliesSensory Aids

Study Officials

  • Peter Matulat

    Department of Phoniatrics and Pediatric Audiology, University Hospital Münster

    PRINCIPAL INVESTIGATOR

  • Antoinette G Dinnesen, Prof. Dr.

    Department of Phoniatrics and Pediatric Audiology, University Hospital Münster

    STUDY DIRECTOR

Central Study Contacts

Peter Matulat

CONTACT

+49(0)251 83matulat@uni-muenster.de

Antoinette G Dinnesen, Prof. Dr.

CONTACT

+49(0)251 83a.g.dinnesen@uni-muenster.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 14, 2005

Study Start

March 1, 2005

Last Updated

August 15, 2007

Record last verified: 2006-05

Locations

CH(1)DE(1)