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

August 14, 2007 updated by: University Hospital Muenster

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Münster, Germany, 48149
        • Recruiting
        • Department of Phoniatrics and Pediatric Audiology, University Hospital Münster
        • Contact:
        • Principal Investigator:
          • Peter Matulat
        • Sub-Investigator:
          • Claus-Michael Schmidt, Dr
  • Switzerland
      • Stäfa, Switzerland, 8712

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
auditory performance
Time Frame: following 26 weeks hearing aid use
following 26 weeks hearing aid use
school performance and satisfaction
Time Frame: following 26 weeks hearing aid use
following 26 weeks hearing aid use
attention
Time Frame: following 26 weeks hearing aid use
following 26 weeks hearing aid use
verbal learning and memory
Time Frame: following 26 weeks hearing aid use
following 26 weeks hearing aid use

Secondary Outcome Measures

Outcome Measure
Time Frame
self concept
Time Frame: following 26 weeks hearing aid use
following 26 weeks hearing aid use
behavior
Time Frame: following 26 weeks hearing aid use
following 26 weeks hearing aid use
listening effort
Time Frame: following 26 weeks hearing aid use
following 26 weeks hearing aid use

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Muenster

Collaborators

Phonak AG, Switzerland

Investigators

  • Principal Investigator: Peter Matulat, Department of Phoniatrics and Pediatric Audiology, University Hospital Münster

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 14, 2005

Study Record Updates

Last Update Posted (Estimate)

August 15, 2007

Last Update Submitted That Met QC Criteria

August 14, 2007

Last Verified

May 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • phonpaed002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Auditory Processing Disorder

Clinical Trials on hearing aid, Phonak EduLink-FM System

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Netherlands

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe