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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jong Woo Chung, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01897181
First received: July 5, 2013
Last updated: February 14, 2016
Last verified: February 2016
  Purpose
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.

Condition Intervention
Auditory Processing Disorder, Central
Device: Hearing aids

Study Type: Interventional
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)

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 27
Study Start Date: July 2013
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01897181

Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Jong Woo Chung
Investigators
Study Chair: Jong Woo Chung, MD Asan Medical Center
  More Information

Responsible Party: Jong Woo Chung, MD, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01897181     History of Changes
Other Study ID Numbers: AMC-2013-0455 
Study First Received: July 5, 2013
Last Updated: February 14, 2016
Health Authority: Korea: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: Undecided
Plan Description: Data is being analyzed.

Keywords provided by Asan Medical Center:
Central auditory processing
Bilateral sensorineural hearing loss
Hearing aids

Additional relevant MeSH terms:
Language Development Disorders
Hearing Loss
Hearing Loss, Sensorineural
Auditory Perceptual Disorders
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Auditory Diseases, Central
Retrocochlear Diseases
Brain Diseases
Central Nervous System Diseases
Perceptual Disorders
Neurobehavioral Manifestations
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Language Disorders
Communication Disorders

ClinicalTrials.gov processed this record on July 24, 2016