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| Sponsor: | Department of Veterans Affairs |
|---|---|
| Information provided by: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00013416 |
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 | Intervention | Phase |
|---|---|---|
|
Hearing Impaired |
Procedure: Hearing |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Measurement and Prediction of Outcomes of Amplification |
| Estimated Enrollment: | 120 |
| Study Start Date: | October 1999 |
| Study Completion Date: | 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:
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 older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Hearing-impaired patients
Contacts and Locations| United States, Tennessee | |
| VAMC, Memphis | |
| Memphis, Tennessee, United States | |
| Investigator: | John Fryer, Ph.D., Asst. Director | Department of Veterans Affairs, Program Analysis and Review Section (PARS), rehabilitation Research & Development Service |
| Investigator: | Nancy Rocheleau, Program Analyst | Department of Veterans Affairs, Program Analysis and Rreview Section (PARS), Rehabilitation Research & Development Service |
More Information
| ClinicalTrials.gov Identifier: | NCT00013416 History of Changes |
| Other Study ID Numbers: | C2002R |
| Study First Received: | March 14, 2001 |
| Last Updated: | January 20, 2009 |
| Health Authority: | United States: Federal Government |
|
Hearing loss, hearing aid, amplification |
|
Deafness Hearing Loss Hearing Disorders Ear Diseases Otorhinolaryngologic Diseases |
Sensation Disorders Neurologic Manifestations Nervous System Diseases Signs and Symptoms |