Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
363 participants
INTERVENTIONAL
2015-08-01
2020-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Central Auditory Processing Disorders Associated With Blast Exposure
NCT00554801
Central Auditory Processing Deficits Associated With Blast Exposure
NCT01567020
Hearing Aids for Veterans With Functional Hearing Difficulties
NCT06117254
Comparing Hearing Aid Fitting Methods in Blast-exposed Veterans
NCT06309264
Evaluation of a Non-invasive Tinnitus Device for the Management of Tinnitus Symptoms in Military Veterans
NCT06905158
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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 (clinical trial portion), a smaller group of participants from the first and second groups will be fitted with mild-gain open-fit hearing aids to determine if they benefit from mild high-frequency amplification. Changes in hearing handicap and speech perception will be compared from baseline to 6-months post-fitting. Perceived hearing aid benefit, hearing aid use time, and intent to continue use will be measured at the end of a 6-month treatment period. A delayed treatment group will be formed from group 1 and will be followed over a 12-month period with hearing aids fitted at 6 months. The participants will be assigned randomly from Part 1 of the study.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Immediate Hearing Aid Treatment: Blast-exposed Only
This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were negative for significant PTSD. They were fitted with open-fit hearing aids that provided mild high-frequency amplification and were monitored for 6 months.
mild-gain hearing aids with high-frequency emphasis over 6-months
open-fit hearing aids with mild amplification in the high frequencies.
Immediate Hearing Aid Treatment: Blast-exposed with PTSD
This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were comorbid for significant PTSD. They were fitted with open-fit hearing aids that provided mild high-frequency amplification and were monitored for 6 months.
mild-gain hearing aids with high-frequency emphasis over 6-months
open-fit hearing aids with mild amplification in the high frequencies.
Delayed Hearing Aid Treatment: Blast-exposed Only
This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were negative for significant PTSD. They were fitted with hearing aids after a 6-month delay. Their performance was monitored 6-months pre-fitting and for the 6 months after the fitting.
mild-gain hearing aids with high-frequency emphasis over 6-months
open-fit hearing aids with mild amplification in the high frequencies.
Non-treatment Diagnostic Testing: Normal
This group consisted of Veterans who completed the same pre-treatment diagnostic testing as the three treatment groups but were not enrolled in the hearing aid treatment protocol. This group included neurotypical Veterans with normal hearing and were negative for blast-exposure and PTSD.
No interventions assigned to this group
Non-Treatment Diagnostic Testing: Blast-exposed Only
This group consisted of Veterans who completed the same pre-treatment diagnostic testing as the three treatment groups but were not enrolled in the hearing aid treatment protocol. This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. They were negative for significant PTSD.
No interventions assigned to this group
Non-treatment Diagnostic Testing: Blast-exposed with PTSD
This group consisted of Veterans who completed the same pre-treatment diagnostic testing as the three treatment groups but were not enrolled in the hearing aid treatment protocol. This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were comorbid for significant PTSD.
No interventions assigned to this group
Non-treatment Diagnostic Testing: PTSD Only
This group consisted of Veterans who completed the same pre-treatment diagnostic testing as the three treatment groups but were not enrolled in the hearing aid treatment protocol. This group was negative for blast-exposure and hearing loss but positive for significant PTSD.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
mild-gain hearing aids with high-frequency emphasis over 6-months
open-fit hearing aids with mild amplification in the high frequencies.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
20 Years
50 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
VA Office of Research and Development
FED
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sheila R Pratt, PhD
Role: PRINCIPAL_INVESTIGATOR
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
VA Portland Health Care System, Portland, OR
Portland, Oregon, United States
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, United States
Sioux Falls VA Health Care System, Sioux Falls, SD
Sioux Falls, South Dakota, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Gallun FJ, Papesh MA, Lewis MS. Hearing complaints among veterans following traumatic brain injury. Brain Inj. 2017;31(9):1183-1187. doi: 10.1080/02699052.2016.1274781.
Gallun FJ, Lewis MS, Folmer RL, Diedesch AC, Kubli LR, McDermott DJ, Walden TC, Fausti SA, Lew HL, Leek MR. Implications of blast exposure for central auditory function: a review. J Rehabil Res Dev. 2012;49(7):1059-74. doi: 10.1682/jrrd.2010.09.0166.
Koerner TK, A Papesh M, Gallun FJ. A Questionnaire Survey of Current Rehabilitation Practices for Adults With Normal Hearing Sensitivity Who Experience Auditory Difficulties. Am J Audiol. 2020 Dec 9;29(4):738-761. doi: 10.1044/2020_AJA-20-00027. Epub 2020 Sep 23.
Folmer RL, Billings CJ, Diedesch-Rouse AC, Gallun FJ, Lew HL. Electrophysiological assessments of cognition and sensory processing in TBI: applications for diagnosis, prognosis and rehabilitation. Int J Psychophysiol. 2011 Oct;82(1):4-15. doi: 10.1016/j.ijpsycho.2011.03.005. Epub 2011 Mar 16.
Papesh MA, Stefl AA, Gallun FJ, Billings CJ. Effects of Signal Type and Noise Background on Auditory Evoked Potential N1, P2, and P3 Measurements in Blast-Exposed Veterans. Ear Hear. 2021 Jan/Feb;42(1):106-121. doi: 10.1097/AUD.0000000000000906.
Hoover EC, Souza PE, Gallun FJ. Auditory and Cognitive Factors Associated with Speech-in-Noise Complaints following Mild Traumatic Brain Injury. J Am Acad Audiol. 2017 Apr;28(4):325-339. doi: 10.3766/jaaa.16051.
Gallun FJ, Diedesch AC, Kubli LR, Walden TC, Folmer RL, Lewis MS, McDermott DJ, Fausti SA, Leek MR. Performance on tests of central auditory processing by individuals exposed to high-intensity blasts. J Rehabil Res Dev. 2012;49(7):1005-25. doi: 10.1682/jrrd.2012.03.0038.
Fausti SA, Wilmington DJ, Gallun FJ, Myers PJ, Henry JA. Auditory and vestibular dysfunction associated with blast-related traumatic brain injury. J Rehabil Res Dev. 2009;46(6):797-810. doi: 10.1682/jrrd.2008.09.0118.
Reavis KM, Snowden JM, Henry JA, Gallun FJ, Lewis MS, Carlson KF. Blast Exposure and Self-Reported Hearing Difficulty in Service Members and Veterans Who Have Normal Pure-Tone Hearing Sensitivity: The Mediating Role of Posttraumatic Stress Disorder. J Speech Lang Hear Res. 2021 Nov 8;64(11):4458-4467. doi: 10.1044/2021_JSLHR-20-00687. Epub 2021 Sep 28.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
C1164-R
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.