Central Auditory Processing and 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 Design:||Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|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)|
- 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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
|Study Start Date:||July 2013|
|Estimated Study Completion Date:||September 2015|
|Estimated Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01897181
|Contact: Jong Woo Chung, MDfirstname.lastname@example.org|
|Korea, Republic of|
|Asan Medical Center||Recruiting|
|Seoul, Korea, Republic of, 138-736|
|Contact: Jong Woo Chung 82-2-3010-3718 email@example.com|
|Study Chair:||Jong Woo Chung, MD||Asan Medical Center|