Measurement and Prediction of Outcomes of Amplification
Primary Purpose
Hearing Impaired
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Hearing
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Impaired focused on measuring Hearing loss, hearing aid, amplification
Eligibility Criteria
Hearing-impaired patients
Sites / Locations
- VAMC, Memphis
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00013416
First Posted
March 14, 2001
Last Updated
January 20, 2009
Sponsor
US Department of Veterans Affairs
1. Study Identification
Unique Protocol Identification Number
NCT00013416
Brief Title
Measurement and Prediction of Outcomes of Amplification
Official Title
Measurement and Prediction of Outcomes of Amplification
Study Type
Interventional
2. Study Status
Record Verification Date
January 2001
Overall Recruitment Status
Completed
Study Start Date
October 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2002 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
US Department of Veterans Affairs
4. Oversight
5. Study Description
Brief Summary
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.
Detailed Description
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:
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.
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.
The post-fitting time course of hearing aid fitting outcome data is different for different outcome variables.
Self-report hearing aid fitting outcomes are stable after 3 months of hearing aid use.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Impaired
Keywords
Hearing loss, hearing aid, amplification
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Hearing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Hearing-impaired patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Fryer, Ph.D., Asst. Director
Organizational Affiliation
Department of Veterans Affairs, Program Analysis and Review Section (PARS), rehabilitation Research & Development Service
First Name & Middle Initial & Last Name & Degree
Nancy Rocheleau, Program Analyst
Organizational Affiliation
Department of Veterans Affairs, Program Analysis and Rreview Section (PARS), Rehabilitation Research & Development Service
Facility Information:
Facility Name
VAMC, Memphis
City
Memphis
State/Province
Tennessee
Country
United States
12. IPD Sharing Statement
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Measurement and Prediction of Outcomes of Amplification
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