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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2006 by University Hospital Muenster.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00167128
First Posted: September 14, 2005
Last Update Posted: August 15, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Phonak AG, Switzerland
Information provided by:
University Hospital Muenster
  Purpose

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 Intervention
Auditory Processing Disorder Device: hearing aid, Phonak EduLink-FM System

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University Hospital Muenster:

Primary Outcome Measures:
  • auditory performance [ Time Frame: following 26 weeks hearing aid use ]
  • school performance and satisfaction [ Time Frame: following 26 weeks hearing aid use ]
  • attention [ Time Frame: following 26 weeks hearing aid use ]
  • verbal learning and memory [ Time Frame: following 26 weeks hearing aid use ]

Secondary Outcome Measures:
  • self concept [ Time Frame: following 26 weeks hearing aid use ]
  • behavior [ Time Frame: following 26 weeks hearing aid use ]
  • listening effort [ Time Frame: following 26 weeks hearing aid use ]

Estimated Enrollment: 30
Study Start Date: March 2005
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   6 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00167128


Contacts
Contact: Peter Matulat +49(0)251 83 ext 56898 matulat@uni-muenster.de
Contact: Antoinette G Dinnesen, Prof. Dr. +49(0)251 83 ext 56859 a.g.dinnesen@uni-muenster.de

Locations
Germany
Department of Phoniatrics and Pediatric Audiology, University Hospital Münster Recruiting
Münster, Germany, 48149
Contact: Peter Matulat    +49(0)251 83 ext 56898    matulat@uni-muenster.de   
Contact: Antoinette G Dinnesen, Prof. Dr.    +49(0)251 83 ext 56859    a.g.dinnesen@uni-muenster.de   
Principal Investigator: Peter Matulat         
Principal Investigator: Antoinette G Dinnesen, Prof. Dr.         
Sub-Investigator: Claus-Michael Schmidt, Dr         
Switzerland
Phonak AG Recruiting
Stäfa, Switzerland, 8712
Contact: Jürgen Tchorz, Dr    +41 1928 ext 0101    juergen.tchorz@phonak.ch   
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
  More Information

ClinicalTrials.gov Identifier: NCT00167128     History of Changes
Other Study ID Numbers: phonpaed002
First Submitted: September 12, 2005
First Posted: September 14, 2005
Last Update Posted: August 15, 2007
Last Verified: May 2006

Keywords provided by University Hospital Muenster:
Auditory Processing Disorder
speech-in-noise intelligibility

Additional relevant MeSH terms:
Auditory Perceptual Disorders
Auditory Diseases, Central
Retrocochlear Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Cognition Disorders
Neurocognitive Disorders
Mental Disorders