Central Auditory Processing and the Use of Hearing Aids (CAPHA)
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|ClinicalTrials.gov Identifier: NCT01897181|
Recruitment Status : Completed
First Posted : July 11, 2013
Last Update Posted : February 17, 2016
|Condition or disease||Intervention/treatment||Phase|
|Auditory Processing Disorder, Central||Device: Hearing aids||Not Applicable|
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)
- 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 (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||July 2013|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
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
- 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.
- 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.
- changes from the baseline in the HINT score at 3, 9, and 12 months [ Time Frame: baseline, 3, 9 and 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01897181
|Korea, Republic of|
|Asan Medical Center|
|Seoul, Korea, Republic of, 138-736|
|Study Chair:||Jong Woo Chung, MD||Asan Medical Center|