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Blast Exposed Veterans With Auditory Complaints

NCT02122458 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 363

Last updated 2023-06-22

Study results available
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Summary

The purpose of this study is to study blast-exposed Veterans who report hearing handicap but show normal or near normal results on standard audiometric testing. The characteristics and nature of their auditory and auditory-related skills will be examined, along with whether coexisting PTSD contributes to the hearing problems of these Veterans. In a preliminary treatment study, a sub-sample of these Veterans will be fitted with mild-gain hearing aids to determine if they benefit from low-level amplification of high-frequency sounds.

Conditions

Interventions

DEVICE

mild-gain hearing aids with high-frequency emphasis over 6-months

open-fit hearing aids with mild amplification in the high frequencies.

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Sheila R Pratt, PhD · VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-08-01
Primary Completion
2020-11-30
Completion
2020-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02122458 on ClinicalTrials.gov