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

Sponsor
University Hospital Muenster (Other)
Overall Status
Unknown status
CT.gov ID
NCT00167128
Collaborator
Phonak AG, Switzerland (Industry)
30
2
15

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: hearing aid, Phonak EduLink-FM System
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Phonak EduLink-System in Students With Specific Performance Deficits in Speech-in-Noise Intelligibility
Study Start Date :
Mar 1, 2005

Outcome Measures

Primary Outcome Measures

  1. auditory performance [following 26 weeks hearing aid use]

  2. school performance and satisfaction [following 26 weeks hearing aid use]

  3. attention [following 26 weeks hearing aid use]

  4. verbal learning and memory [following 26 weeks hearing aid use]

Secondary Outcome Measures

  1. self concept [following 26 weeks hearing aid use]

  2. behavior [following 26 weeks hearing aid use]

  3. listening effort [following 26 weeks hearing aid use]

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 11 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Phoniatrics and Pediatric Audiology, University Hospital Münster Münster Germany 48149
2 Phonak AG Stäfa Switzerland 8712

Sponsors and Collaborators

  • University Hospital Muenster
  • Phonak AG, Switzerland

Investigators

  • Principal Investigator: Peter Matulat, Department of Phoniatrics and Pediatric Audiology, University Hospital Münster
  • Study Director: Antoinette G Dinnesen, Prof. Dr., Department of Phoniatrics and Pediatric Audiology, University Hospital Münster

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00167128
Other Study ID Numbers:
  • phonpaed002
First Posted:
Sep 14, 2005
Last Update Posted:
Aug 15, 2007
Last Verified:
May 1, 2006
Keywords provided by , ,
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 15, 2007