Central Auditory Processing and the Use of Hearing Aids

Study Overview
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Brief Summary
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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
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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

Official Title
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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)

Conditions
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Auditory Processing Disorder, Central

Intervention / Treatment
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* Device: Hearing aids


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

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 | 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 |  | baseline, 3, 9 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Central auditory processing, Bilateral sensorineural hearing loss, Hearing aids