Quantifying Auditory Perceptual Learning Following Hearing Aid Fitting
Primary Purpose
Hearing Loss
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Hearing
Sponsored by
About this trial
This is an interventional diagnostic trial for Hearing Loss focused on measuring Hearing aid, hearing impaired
Eligibility Criteria
Hearing impaired adults
Sites / Locations
- VAMC, Pittsburgh
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00013455
First Posted
March 14, 2001
Last Updated
January 20, 2009
Sponsor
US Department of Veterans Affairs
1. Study Identification
Unique Protocol Identification Number
NCT00013455
Brief Title
Quantifying Auditory Perceptual Learning Following Hearing Aid Fitting
Official Title
Quantifying Auditory Perceptual Learning Following Hearing Aid Fitting
Study Type
Interventional
2. Study Status
Record Verification Date
May 2002
Overall Recruitment Status
Completed
Study Start Date
August 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
US Department of Veterans Affairs
4. Oversight
5. Study Description
Brief Summary
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?
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
Keywords
Hearing aid, hearing impaired
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Hearing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Hearing impaired adults
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Wolff, Ph.D., Special Assistant to the Director, Ph.D.
Organizational Affiliation
Department of Veterans Affairs, Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service
Facility Information:
Facility Name
VAMC, Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
12. IPD Sharing Statement
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Quantifying Auditory Perceptual Learning Following Hearing Aid Fitting
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