CAPHA: Central Auditory Processing and the Use of Hearing Aids

• Sponsor: Jong Woo Chung (Other)
• Overall Status: Completed
• CT.gov ID: NCT01897181
• Collaborator: (none)
• Enrollment: 27
• Location: 1
• Arms: 2
• Duration (Months): 29
• Patients Per Site Per Month: 0.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Auditory Processing Disorder, Central	Device: Hearing aids	N/A

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 27 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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)
• Study Start Date: Jul 1, 2013
• Actual Primary Completion Date: Dec 1, 2015
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Change from the baseline in the Hearing In Noise Test (HINT) score at 6 months [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.

Secondary Outcome Measures

1. changes from the baseline in central auditory processing disorder test score at 1, 3, 6, 9 and 12 months [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.

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jong Woo Chung, MD, Asan Medical Center
• ClinicalTrials.gov Identifier: NCT01897181
• Other Study ID Numbers: AMC-2013-0455
• First Posted: Jul 11, 2013
• Last Update Posted: Feb 17, 2016
• Last Verified: Feb 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Jong Woo Chung, MD, Asan Medical Center: Central auditory processing; Bilateral sensorineural hearing loss; Hearing aids
• Additional relevant MeSH terms: Auditory Perceptual Disorders; Language Development Disorders

Study Results

No Results Posted as of Feb 17, 2016