Central Auditory Processing and the Use of Hearing Aids

Auditory Processing Disorder, Central Clinical Trial

— CAPHA  

Official title:

Evaluation of the Central Auditory Processing in Patients (Elder Than 45 Years Old) With Bilateral Sensorineural Hearing Loss and the Change of the Central Auditory Processing Ability by the Use of Hearing Aids (CAPHA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01897181
• Other study ID #: AMC-2013-0455
• Status: Completed
• Phase: N/A
• First received: July 5, 2013
• Last updated: February 14, 2016
• Start date: July 2013
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the central auditory processing in patients with bilateral sensorineural hearing loss and to observe the change of the central auditory processing ability after using hearing aids.

Description:

Screening for recruiting

• Among patients who are visiting for hearing disturbance, patients with bilateral sensorineural hearing loss will be included after audiologic tests, history taking and physical examination.

• audiologic tests: pure tone audiometry, speech audiometry, impedence audiometry, distortion product otoacoustic emission, auditory brainstem response.

Dividing into "Hearing aids" group and "No hearing aids" group

• The use of hearing aids will be recommended to all included patients.

• Hearing aids group: patients who want to be prescribed hearing aids (28 subjects)

• No hearing aids group: patients who do not want to be prescribed hearing aids (28 subjects)

Audiologic test

• Hearing in noise test (HINT), central auditory processing disorder test

• at screening, 1, 3, 6, 9 and 12 months after starting hearing aids use

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• Adults of age 45 years of older

• Bilateral sensorineural hearing loss

• Average pure tone audiometry threshold >= 40dB

• Speech discrimination >= 60% in both ears

Exclusion Criteria:

• Refusing the study

• Medical history of any brain damage or intracranial surgery

• Showing signs of central lesion in MRI or neurologic exams

• Speech discrimination < 60% in any ear

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Auditory Perceptual Disorders
• Auditory Processing Disorder, Central
• Hearing Loss, Sensorineural
• Language Development Disorders

Intervention

Device:
• Hearing aids
Using hearing aids for 12 months

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Jong Woo Chung

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from the baseline in the Hearing In Noise Test (HINT) score at 6 months	HINT measures a person's ability to hear speech in quiet and in noise. In the test, the patient is required to repeat sentences both in a quiet environment and with competing noise being presented from different directions.	at screening and 6 months after starting hearing aids use	No
Secondary	changes from the baseline in central auditory processing disorder test score at 1, 3, 6, 9 and 12 months	The central auditory processing disorder test is composed of three subtests; duration pattern test, frequency pattern test and dichotic words test. The patient is required to discriminate long duration sound from short one and high frequency sound from low one, and to repeat two words that are given simultaneously.	at screening, 1, 3, 6, 9, and 12 months after starting hearing aids use	No
Secondary	changes from the baseline in the HINT score at 3, 9, and 12 months		baseline, 3, 9 and 12 months	No