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Completed

NCT Number: NCT01897181

Central Auditory Processing and the Use of Hearing Aids

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.

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Key information

Conditions

Auditory Processing Disorder, Central Communication Disorders Language Development Disorders Language Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asan Medical Center

Seoul, 138-736, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hearing aids

Device

Using hearing aids for 12 months

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

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

    Time frame: baseline, 3, 9 and 12 months

Sponsors and collaborators

Lead sponsor

Jong Woo Chung

Other

Registry information

Official study 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)

Acronym: CAPHA

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jul 11, 2013
Registry last updated
Feb 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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