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| Tracking Information | |||||
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| First Received Date ICMJE | March 14, 2001 | ||||
| Last Updated Date | January 20, 2009 | ||||
| Start Date ICMJE | August 2000 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00013455 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Quantifying Auditory Perceptual Learning Following Hearing Aid Fitting | ||||
| Official Title ICMJE | Quantifying Auditory Perceptual Learning Following Hearing Aid Fitting | ||||
| 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? |
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| 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. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Diagnostic, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study | ||||
| Condition ICMJE | Hearing Loss | ||||
| Intervention ICMJE | Device: Hearing | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 48 | ||||
| Completion Date | August 2003 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Hearing impaired adults |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00013455 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | C2236R | ||||
| Study Sponsor ICMJE | Department of Veterans Affairs | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Department of Veterans Affairs | ||||
| Verification Date | May 2002 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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