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Blast Exposed Veterans With Auditory Complaints

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ClinicalTrials.gov Identifier: NCT02122458
Recruitment Status : Recruiting
First Posted : April 24, 2014
Last Update Posted : October 10, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief 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.

Condition or disease Intervention/treatment Phase
Hearing Impairment Hearing Aid Fitting Device: mild-gain hearing aids Phase 1

Detailed Description:

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 with a battery of behavioral and physiologic measures. The potential contributions of co-occurring PTSD also will be evaluated. In a preliminary treatment study, a sub-sample of the targeted Veterans will be fitted with mild-gain hearing aids to determine if they benefit from low-level amplification of high-frequency sounds.

This study consists of two parts. In Part 1, four groups of Veterans, aged 20 - 50 years, will complete a battery of auditory and auditory-related assessments to better understand the deficit sources and patterns. The assessment measures will consist of questionnaires, behavioral tests, and auditory physiologic measures. One group will consist of blast-exposed Veterans with auditory problems but no PTSD. The second group will consist of blast-exposed Veterans with auditory problems plus PTSD. The third group will consist of Veterans with PTSD but no reported auditory problems, and the fourth groups will be a normal control group.

In Part 2 of the study, 25 participants from group 1, and 25 participants from group 2 will be fitted with mild-gain open-fit hearing aids. Changes in hearing handicap, hearing aid benefit, hearing aid use time, intent to continue use, and speech perception will be measured over a 6-month period. A delayed treatment group populated from group 1 will be followed over a 12-month period with hearing aids fitted at 6 months. The participants will be assigned randomly from Part 1, but can decline participation.

The information obtained from this study will help us understand the auditory problems experienced by blast-exposed Veterans and eventually contribute to the development of an efficient and effective assessment battery and intervention approaches.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 468 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Blast-exposed Veterans With Auditory Complaints
Actual Study Start Date : August 1, 2015
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: hearing impaired vs hearing impaired + PTSD
The investigators will have two treatment groups fitted with mild-gain open-fit hearing aids and will be monitored across 6 months.
Device: mild-gain hearing aids
open-fit hearing aids with mild amplification in the high frequencies.
Other Name: hearing aids

delayed treatment
A third group will consist of a delayed treatment group. This group will be monitored over 12 months with hearing aids fitted at 6 months.
Device: mild-gain hearing aids
open-fit hearing aids with mild amplification in the high frequencies.
Other Name: hearing aids

No Intervention: Diagnostic Testing
Battery of auditory and auditory related assessment tasks.



Primary Outcome Measures :
  1. Hearing Handicap [ Time Frame: 6 months ]
    Self-perceived hearing handicap as measured with the Hearing Handicap Inventory for Adults

  2. Hearing Aid Benefit [ Time Frame: 6 months ]
    Self-perceived hearing aid benefit

  3. Intent to continue use [ Time Frame: 6 months ]
    Indication of whether the participants will continue to use the hearing aids after the study has ended


Secondary Outcome Measures :
  1. Hearing Aid Use Time [ Time Frame: 6 months ]
    Average daily use of hearing aids

  2. Speech Perception [ Time Frame: 6 months ]
    Aided and unaided speech perception in noise and in quiet



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age 20 - 50 years; U.S. Veteran;
  • English-speaking;
  • history of blast exposure and no history of blast exposure;
  • history of PTSD and no history of PTSD;
  • self-perceived hearing handicap and no self-perceived hearing handicap;
  • normal or near normal pure tone hearing thresholds;
  • history of brain injury and no history of brain injury;
  • normal vision.

Exclusion Criteria:

  • hyperacusis;
  • marked tinnitus;
  • pure tone hearing thresholds consistent with a hearing loss;
  • greater the 20/30 vision screening results (corrected or uncorrected);
  • marked speech perception deficits

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02122458


Contacts
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Contact: Sheila R Pratt, PhD Sheila.Pratt@va.gov
Contact: Elizabeth G Haley (412) 360-6409 Elizabeth.Haley@va.gov

Locations
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United States, Oregon
VA Portland Health Care System, Portland, OR Recruiting
Portland, Oregon, United States, 97239
Contact: Frederick Gallun, PhD    503-220-8262 ext 57472    Frederick.Gallun@va.gov   
United States, Pennsylvania
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA Recruiting
Pittsburgh, Pennsylvania, United States, 15240
Contact: Sheila R Pratt, PhD       Sheila.Pratt@va.gov   
Contact: Elizabeth G Haley    (412) 360-6409    Elizabeth.Haley@va.gov   
Principal Investigator: Sheila R Pratt, PhD         
United States, South Dakota
Sioux Falls VA Health Care System, Sioux Falls, SD Recruiting
Sioux Falls, South Dakota, United States, 57117-5046
Contact: Lindsey E Jorgensen, PhD    605-677-5474    Lindsey.Jorgensen@va.gov   
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Sheila R Pratt, PhD VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02122458     History of Changes
Other Study ID Numbers: C1164-R
First Posted: April 24, 2014    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
hearing impairment
post-traumatic stress disorder
traumatic brain injury
auditory processing disorder
Additional relevant MeSH terms:
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Hearing Loss
Deafness
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms