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

Primary Purpose

Auditory Processing Disorder

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
hearing aid, Phonak EduLink-FM System
Sponsored by
University Hospital Muenster
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Auditory Processing Disorder focused on measuring Auditory Processing Disorder, speech-in-noise intelligibility

Eligibility Criteria

6 Years - 11 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Department of Phoniatrics and Pediatric Audiology, University Hospital MünsterRecruiting
  • Phonak AGRecruiting

Outcomes

Primary Outcome Measures

auditory performance
school performance and satisfaction
attention
verbal learning and memory

Secondary Outcome Measures

self concept
behavior
listening effort

Full Information

First Posted
September 12, 2005
Last Updated
August 14, 2007
Sponsor
University Hospital Muenster
Collaborators
Phonak AG, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT00167128
Brief Title
The Phonak EduLink-System in Students With Specific Performance Deficits in Speech-in-Noise Intelligibility
Official Title
The Phonak EduLink-System in Students With Specific Performance Deficits in Speech-in-Noise Intelligibility
Study Type
Interventional

2. Study Status

Record Verification Date
May 2006
Overall Recruitment Status
Unknown status
Study Start Date
March 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital Muenster
Collaborators
Phonak AG, Switzerland

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Auditory Processing Disorder
Keywords
Auditory Processing Disorder, speech-in-noise intelligibility

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
hearing aid, Phonak EduLink-FM System
Primary Outcome Measure Information:
Title
auditory performance
Time Frame
following 26 weeks hearing aid use
Title
school performance and satisfaction
Time Frame
following 26 weeks hearing aid use
Title
attention
Time Frame
following 26 weeks hearing aid use
Title
verbal learning and memory
Time Frame
following 26 weeks hearing aid use
Secondary Outcome Measure Information:
Title
self concept
Time Frame
following 26 weeks hearing aid use
Title
behavior
Time Frame
following 26 weeks hearing aid use
Title
listening effort
Time Frame
following 26 weeks hearing aid use

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peter Matulat
Phone
+49(0)251 83
Ext
56898
Email
matulat@uni-muenster.de
First Name & Middle Initial & Last Name or Official Title & Degree
Antoinette G Dinnesen, Prof. Dr.
Phone
+49(0)251 83
Ext
56859
Email
a.g.dinnesen@uni-muenster.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Matulat
Organizational Affiliation
Department of Phoniatrics and Pediatric Audiology, University Hospital Münster
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Antoinette G Dinnesen, Prof. Dr.
Organizational Affiliation
Department of Phoniatrics and Pediatric Audiology, University Hospital Münster
Official's Role
Study Director
Facility Information:
Facility Name
Department of Phoniatrics and Pediatric Audiology, University Hospital Münster
City
Münster
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Matulat
Phone
+49(0)251 83
Ext
56898
Email
matulat@uni-muenster.de
First Name & Middle Initial & Last Name & Degree
Antoinette G Dinnesen, Prof. Dr.
Phone
+49(0)251 83
Ext
56859
Email
a.g.dinnesen@uni-muenster.de
First Name & Middle Initial & Last Name & Degree
Peter Matulat
First Name & Middle Initial & Last Name & Degree
Antoinette G Dinnesen, Prof. Dr.
First Name & Middle Initial & Last Name & Degree
Claus-Michael Schmidt, Dr
Facility Name
Phonak AG
City
Stäfa
ZIP/Postal Code
8712
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jürgen Tchorz, Dr
Phone
+41 1928
Ext
0101
Email
juergen.tchorz@phonak.ch

12. IPD Sharing Statement

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

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