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Measurement and Prediction of Outcomes of Amplification - Article


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Deafness & Hearing Loss




Clinical Trial: Measurement and Prediction of Outcomes of Amplification

This study is no longer recruiting patients.

Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs

Purpose

The long-term goal of this research program is to develop methods to predict both the benefit and the satisfaction that hearing-impaired patients will derive from auditory amplification in daily life. This proposal has three primary objectives: (1) To determine the influence of extra-audiological variables, such as personality attributes and expectations, on the subjective outcomes of hearing aid fittings, (2) To establish a scientific basis for selection, administration, and interpretation of self-report measures of hearing aid fitting outcome, (3) To resolve the long-standing debate about the efficacy of using clinically measured loudness perception data in hearing aid prescriptions.

Condition Treatment or Intervention Phase
Hearing impaired
 Procedure: Hearing
Phase II

MedlinePlus related topics:  Hearing Disorders and Deafness

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study

Further Study Details: 

Expected Total Enrollment:  120

Study start: October 1999;  Study completion: September 2002

The long-term goal of this research program is to develop methods where by clinicians can predict both the benefit and the satisfaction that individual hearing-impaired patients will derive from amplification in daily life. The present proposal continues the research directions pursued in several cycles of previous RR&D funding from 1986 to 1996. This proposal has three primary objectives: (1) To determine the influence of extra-audiological variables, such as personality attributes and expectations, on the subjective outcomes of hearing aid fittings, (2) To establish a scientific basis for selection, administration, and interpretation of self-report measures of hearing aid fitting outcome, (3) To resolve the long-standing debate about the efficacy of using clinically measured loudness perception data in hearing aid prescriptions. HYPOTHESES:

1. Inter-subject differences in personality traits, coping style, and/or expectations account for a significant and substantial amount of the variance in hearing aid fitting outcomes, independent of hearing impairment and fitting strategy.

2. Prediction of hearing aid fitting outcomes will be substantially improved if the prediction model includes extra-audiological data as well as data on impairment and hearing aid.

3. The post-fitting time course of hearing aid fitting outcome data is different for different outcome variables.

4. Self-report hearing aid fitting outcomes are stable after 3 months of hearing aid use.

5. Fitting outcomes are optimized for individuals with unpredictable loudness perception when clinically measured loudness data are used in the hearing aid fitting protocol.

PROCEDURES: Investigations will explore:(1)the determinants and characteristics of subjective outcome variables, and (2) the value of individual loudness data in hearing aid fitting. Subjects will be elderly men and women with bilateral sensorineural hearing loss. The work will be performed at the Memphis VAMC Hearing Aid Research Laboratory.

Determinants and characteristics of subjective outcome variables. When self-reports are used to evaluate hearing aid fitting outcome, it is assumed that the data primarily reflect the efficacy of the hearing aid and the fitting strategy. There is a lack of information about the extent to which other variables might impact self-report data. We will explore this topic with 120 potential hearing aid wearers, followed from their initial expression of interest in amplification through the entire fitting process and for six months after the fitting. Data describing a range of pre-fitting variables as well as hearing impairment, and hearing aid fitting will be collected in a consortium of six clinical sites (including 5 VA sites) coordinated from the Memphis laboratory. The Memphis research team will complete data collection with each subject by collecting outcome data at three post-fitting intervals.

Eligibility

Ages Eligible for Study:  60 Years and above,  Genders Eligible for Study:  Both

Criteria

Hearing-impaired patients

Location Information


Tennessee
      VAMC, Memphis, Memphis,  Tennessee,  United States

Study chairs or principal investigators

John Fryer, Ph.D., Asst. Director,  Department of Veterans Affairs, Program Analysis and Review Section (PARS), rehabilitation Research & Development Service   
Nancy Rocheleau, Program Analyst,  Department of Veterans Affairs, Program Analysis and Rreview Section (PARS), Rehabilitation Research & Development Service   

More Information

Study ID Numbers:  C2002
Record last reviewed:  January 2001
Last Updated:  October 13, 2004
Record first received:  March 14, 2001
ClinicalTrials.gov Identifier:  NCT00013416
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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December 4, 2008



Page Updated: September 6, 2005
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