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

Primary Purpose

Auditory Processing Disorder, Central

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Hearing aids
Sponsored by
Jong Woo Chung
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Auditory Processing Disorder, Central focused on measuring Central auditory processing, Bilateral sensorineural hearing loss, Hearing aids

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Asan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Hearing aids

No hearing aids

Arm Description

Patients who agree to use hearing aids

Patients who did not agree to use hearing aids

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
changes from the baseline in the HINT score at 3, 9, and 12 months

Full Information

First Posted
July 5, 2013
Last Updated
February 14, 2016
Sponsor
Jong Woo Chung
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1. Study Identification

Unique Protocol Identification Number
NCT01897181
Brief Title
Central Auditory Processing and the Use of Hearing Aids
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jong Woo Chung

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Auditory Processing Disorder, Central
Keywords
Central auditory processing, Bilateral sensorineural hearing loss, Hearing aids

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hearing aids
Arm Type
Active Comparator
Arm Description
Patients who agree to use hearing aids
Arm Title
No hearing aids
Arm Type
No Intervention
Arm Description
Patients who did not agree to use hearing aids
Intervention Type
Device
Intervention Name(s)
Hearing aids
Intervention Description
Using hearing aids for 12 months
Primary Outcome Measure Information:
Title
Change from the baseline in the Hearing In Noise Test (HINT) score at 6 months
Description
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.
Time Frame
at screening and 6 months after starting hearing aids use
Secondary Outcome Measure Information:
Title
changes from the baseline in central auditory processing disorder test score at 1, 3, 6, 9 and 12 months
Description
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.
Time Frame
at screening, 1, 3, 6, 9, and 12 months after starting hearing aids use
Title
changes from the baseline in the HINT score at 3, 9, and 12 months
Time Frame
baseline, 3, 9 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jong Woo Chung, MD
Organizational Affiliation
Asan Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Data is being analyzed.

Learn more about this trial

Central Auditory Processing and the Use of Hearing Aids

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