Auditory Processing Disorder, CentralCAPHANCT01897181
Central Auditory Processing and the Use of Hearing Aids
A study testing Hearing aids in people with Auditory Processing Disorder, Central, run by Jong Woo Chung at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Auditory Processing Disorder, Central
- What is being tested?
- Hearing aids
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults of age 45 years of older
- Bilateral sensorineural hearing loss
- Average pure tone audiometry threshold >= 40dB
- Speech discrimination >= 60% in both ears
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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
- Conditions
- Auditory Processing Disorder, Central
- Being tested
- Hearing aids
- Keywords
- Central auditory processing, Bilateral sensorineural hearing loss, Hearing aids
- Medical subject headings
- Language Development Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hearing aidsDevice
Using hearing aids for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Hearing aids | Active comparator | Patients who agree to use hearing aids Receives: Device: Hearing aids |
| No hearing aids | No intervention | Patients who did not agree to use hearing aids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from the baseline in the Hearing In Noise Test (HINT) score at 6 months
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.
Measured: at screening and 6 months after starting hearing aids use
Secondary outcomes (2)
changes from the baseline in central auditory processing disorder test score at 1, 3, 6, 9 and 12 months
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.
Measured: at screening, 1, 3, 6, 9, and 12 months after starting hearing aids use
changes from the baseline in the HINT score at 3, 9, and 12 months
Measured: baseline, 3, 9 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Auditory Processing Disorder, CentralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jong Woo Chung
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jong Woo Chung, Asan Medical Center
- Investigators
- Jong Woo Chung, MD, Study chair, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01897181
- Sponsor's protocol ID
- AMC-2013-0455
- Acronym
- CAPHA
- Status last verified
- Feb 2016
- First submitted
- 5 Jul 2013
- Last updated
- 17 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: Data is being analyzed.
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01897181
- Acronym / sponsor ID
- CAPHA / AMC-2013-0455
- Conditions
- Auditory Processing Disorder, Central
- Keywords
- Central auditory processing, Bilateral sensorineural hearing loss, Hearing aids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Jong Woo ChungUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 11 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hearing aids | Active comparator | Device: Hearing aidsPatients who agree to use hearing aids |
| No hearing aids | No intervention | –Patients who did not agree to use hearing aids |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults of age 45 years of older
- Bilateral sensorineural hearing loss
- Average pure tone audiometry threshold >= 40dB
- Speech discrimination >= 60% in both ears
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hearing aidsUsing hearing aids for 12 months | Device | Hearing aids |
Primary outcome
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.
2 secondary outcomes
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
changes from the baseline in the HINT score at 3, 9, and 12 months
Time frame: baseline, 3, 9 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2016.
- Individual participant dataSharing planned: Undecided. Data is being analyzed.
Related trials for Auditory Processing Disorder, Central
Recruiting
Central Auditory Processing Modulation Underlying Anxiety Reduction Using Clinically Designed Improvisatory Music
Alzheimer's Disease
Active, not recruiting
Mental And Speech Developmental Delay Autism Spectrum-Type Behavioral Disorder
Autism Spectrum Disorder (ASD), Central Auditory Processing Disorder
RecruitingPhase 1/2
A Treatment for a Form of Age-Related Central Auditory Processing Disorder Consisting of Clemastine Fumarate Plus Engineered Sound
Central Auditory Processing Disorder, Hearing Impaired (Partially)
Recruiting
Hearing Aids for Veterans With Functional Hearing Difficulties
Auditory Processing Disorder
Recruiting
Comparing Hearing Aid Fitting Methods in Blast-exposed Veterans
Auditory Diseases, Central
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jong Woo Chung, MD study chair
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hearing aids in people with Auditory Processing Disorder, Central, run by Jong Woo Chung at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2016.