NCT00013455

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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2000

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2000

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2001

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 16, 2001

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2003

Completed
Last Updated

January 21, 2009

Status Verified

May 1, 2002

First QC Date

March 14, 2001

Last Update Submit

January 20, 2009

Conditions

Keywords

Hearing aid, hearing impaired

Interventions

HearingDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Hearing impaired adults

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

VAMC, Pittsburgh

Pittsburgh, Pennsylvania, United States

Location

MeSH Terms

Conditions

Hearing Loss

Interventions

Audiometry

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hearing TestsDiagnostic Techniques, OtologicalDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • David Wolff, Ph.D., Special Assistant to the Director, Ph.D.

    Department of Veterans Affairs, Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
FED

Study Record Dates

First Submitted

March 14, 2001

First Posted

March 16, 2001

Study Start

August 1, 2000

Study Completion

August 1, 2003

Last Updated

January 21, 2009

Record last verified: 2002-05

Locations