- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00013455
Quantifying Auditory Perceptual Learning Following Hearing Aid Fitting
January 20, 2009 updated by: US Department of Veterans Affairs
The purpose of this study is to examine and relate physiological, behavioral, and self-perceived changes after a period of hearing aid use and as a function of auditory training.
The project will focus on the following questions: 1)Is experience-related behavioral change in hearing aid performance reflected as a neurophysiologic change?
2)Does a neurophysiologic change occur prior to or in conjunction with an experience-related behavioral change?
3) Does behavioral training modify the neurophysiologic representation of speech following the provision of hearing aids?
4)What is the relationship between physiologic, behavioral,and self-perceived change impacted by behavioral training?
5)Are neurophysiologic changes limited to trained stimuli or does auditory training alter neurophysiological responses?
Study Overview
Detailed Description
The purpose of this study is to examine and relate physiological, behavioral, and self-perceived changes after a period of hearing aid use and as a function of auditory training.
The primary objective of this study is to determine how physiological changes may be related to functional changes.
The design of this experiment also will allow for evaluation of training effects, in particular, whether training enhances physiological change and further whether specific training transfers functionally and physiologically to similar stimuli.
The proposed project will focus on the following questions: 1) Is an experience-related behavioral change in hearing aid performance over time reflected as a neurophysiologic change in the central auditory system? 2) Does a neurophysiologic change occur prior to or in conjunction with an experience-related behavioral change in hearing aid performance over time? 3) Does behavioral training over an extended period of time modify the neurophysiologic representation of speech following the provision of hearing aids? 4) What is the relationship between physiologic, behavioral, and self-perceived change over time and is this relationship impacted by behavioral training?
5) Are neurophysiologic changes in acoustic representations at a pre-attentive level limited to trained stimuli or does auditory training following the provision of hearing aids alter neurophysiological responses to novel speech sounds with acoustic content similar to the trained stimuli?
Forty-eight hearing-impaired adults between the ages of 18 and 60 with no hearing aid experience will serve as subjects.
Subjects will be randomly assigned to one of two experimental groups: a. individuals who receive auditory exposure in the real-world only; b. individuals who receive intense, controlled auditory practice with feedback, in addition to auditory exposure in the real world.
Dependent variables will include measures of behavioral function (frequency specific speech recognition and confidence in different levels of noise), physiological function (amplitude and latency of mismatch negativity), and self-perception (Abbreviated Profile of Hearing Aid Benefit) over time.
Data will be analyzed to evaluate relative change over time for each dependent variable and also to examine the relationship between the dependent variables considering hours of hearing aid use and audibility as potential covariates.
Study Type
Interventional
Enrollment (Anticipated)
48
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pennsylvania
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Pittsburgh, Pennsylvania, United States
- VAMC, Pittsburgh
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Hearing impaired adults
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- David Wolff, Ph.D., Special Assistant to the Director, Ph.D., Department of Veterans Affairs, Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2000
Study Completion (Actual)
August 1, 2003
Study Registration Dates
First Submitted
March 14, 2001
First Submitted That Met QC Criteria
March 15, 2001
First Posted (Estimate)
March 16, 2001
Study Record Updates
Last Update Posted (Estimate)
January 21, 2009
Last Update Submitted That Met QC Criteria
January 20, 2009
Last Verified
May 1, 2002
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- C2236R
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.