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

Auditory Processing Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00167128
• Other study ID #: phonpaed002
• Status: Recruiting
• Phase: N/A
• First received: September 12, 2005
• Last updated: August 14, 2007
• Start date: March 2005

Study information

• Verified date: May 2006
• Source: University Hospital Muenster
• Contact: Peter Matulat
• Phone: +49(0)251 83
• Email: matulat[@]uni-muenster.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 11 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Auditory Perceptual Disorders
• Auditory Processing Disorder

Intervention

Device:
• hearing aid, Phonak EduLink-FM System

Locations

Country	Name	City	State
Germany	Department of Phoniatrics and Pediatric Audiology, University Hospital Münster	Münster
Switzerland	Phonak AG	Stäfa

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Muenster	Phonak AG, Switzerland

Countries where clinical trial is conducted

Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	auditory performance		following 26 weeks hearing aid use
Primary	school performance and satisfaction		following 26 weeks hearing aid use
Primary	attention		following 26 weeks hearing aid use
Primary	verbal learning and memory		following 26 weeks hearing aid use
Secondary	self concept		following 26 weeks hearing aid use
Secondary	behavior		following 26 weeks hearing aid use
Secondary	listening effort		following 26 weeks hearing aid use