Central Auditory Processing and the Use of Hearing Aids (CAPHA)

February 14, 2016 updated by: Jong Woo Chung

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Hearing aids
Patients who agree to use hearing aids
Device: Hearing aids
Using hearing aids for 12 months
No Intervention: No hearing aids
Patients who did not agree to use hearing aids

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from the baseline in the Hearing In Noise Test (HINT) score at 6 months
Time Frame: at screening and 6 months after starting hearing aids use
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes from the baseline in central auditory processing disorder test score at 1, 3, 6, 9 and 12 months
Time Frame: at screening, 1, 3, 6, 9, and 12 months after starting hearing aids use
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
changes from the baseline in the HINT score at 3, 9, and 12 months
Time Frame: baseline, 3, 9 and 12 months
baseline, 3, 9 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jong Woo Chung

Investigators

  • Study Chair: Jong Woo Chung, MD, Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

July 5, 2013

First Submitted That Met QC Criteria

July 9, 2013

First Posted (Estimate)

July 11, 2013

Study Record Updates

Last Update Posted (Estimate)

February 17, 2016

Last Update Submitted That Met QC Criteria

February 14, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMC-2013-0455

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data is being analyzed.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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