Hearing ImpairmentNCT02122458

Blast Exposed Veterans With Auditory Complaints

A study testing mild-gain hearing aids with high-frequency emphasis over 6-months in people with Hearing Impairment and Hearing Aid Fitting, run by VA Office of Research and Development at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 20 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Hearing Impairment, Hearing Aid Fitting
What is being tested?: mild-gain hearing aids with high-frequency emphasis over 6-months
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 363 participants
Where: 3 sitesUnited States
Study dates: 1 Aug 2015to 31 Dec 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, 15240
VA Portland Health Care System, Portland, OR
Portland, Oregon, 97239
Sioux Falls VA Health Care System, Sioux Falls, SD
Sioux Falls, South Dakota, 57117-5046

Other trials in United States

About this study

Official title: Blast-exposed Veterans With Auditory Complaints

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.

Read the 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 (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: Hearing Impairment, Hearing Aid Fitting
Being tested: mild-gain hearing aids with high-frequency emphasis over 6-months
Keywords: hearing impairment, post-traumatic stress disorder, traumatic brain injury, auditory processing disorder
Medical subject headings: Hearing Loss, Stress Disorders, Post-Traumatic, Brain Injuries, Traumatic, Auditory Perceptual Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

mild-gain hearing aids with high-frequency emphasis over 6-monthsDevice
Also called hearing aids
open-fit hearing aids with mild amplification in the high frequencies.

Study groups in NCT02122458
Study group	Role	What they receive
Immediate Hearing Aid Treatment: Blast-exposed Only	Active comparator	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. Receives: Device: mild-gain hearing aids with high-frequency emphasis over 6-months
Immediate Hearing Aid Treatment: Blast-exposed with PTSD	Active comparator	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. Receives: Device: mild-gain hearing aids with high-frequency emphasis over 6-months
Delayed Hearing Aid Treatment: Blast-exposed Only	Active comparator	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. Receives: Device: mild-gain hearing aids with high-frequency emphasis over 6-months
Non-treatment Diagnostic Testing: Normal	No intervention	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.
Non-Treatment Diagnostic Testing: Blast-exposed Only	No intervention	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.
Non-treatment Diagnostic Testing: Blast-exposed with PTSD	No intervention	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.
Non-treatment Diagnostic Testing: PTSD Only	No intervention	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.

What is being measured

The primary outcome is the main question the study is designed to answer.

Hearing Handicap Inventory for Adults (HHIA)
Self-perceived hearing handicap was measured with the Hearing Handicap Inventory for Adults (HHIA), pre- and 6-months post-hearing aid fitting. The minimum score is 0 and the maximum score is 100, with the higher score reflecting greater handicap (worse outcome). The data are presented as a comparison between the two questionnaire administrations (pre- and 6-months post-fitting). The null hypothesis tested was that there would be no difference between the HHIA administered at baseline (pre-fitting) and 6-months post-fitting for all groups.
Measured: The participants wore their hearing aids for 6 months-fitting (baseline to 6-months post-fitting). The delayed group had a 6-month delay prior to treatment.
Hearing Aid Benefit (Abbreviated Profile of Hearing Aid Benefit, APHAB)
The Abbreviated Profile of Hearing Aid Benefit (APHAB) was administered at the end of the treatment period (6-months post-fitting) to measure self-perceived benefit. The APHAB is a 24-item self-assessment inventory used to indicate the extent to which listeners experience listening difficulties (with and without hearing aids) in various settings. The questionnaire uses a 7-point scale that corresponds to the frequency with which difficulties are experienced (99 to 1% of the time). The APHAB was administered for both unaided listening and aided listening, and benefit was calculated by subtracting the mean aided scores from the mean unaided scores. Higher benefit scores (e.g., 99% unaided - 25% aided vs. 99% unaided - 50% aided) reflected greater benefit (better outcome) and negative scores were possible. The null hypothesis tested was that no hearing aid benefit would be demonstrated by any of the 3 groups at 6-months post-fitting.
Measured: The APHAB was administered 6-months post-fitting. The delayed group had a 6-month delay prior to the treatment (6-months of wearing the hearing aids).
Intent to Continue Use
The participants reported whether they would continue to use their hearing aids after the study has ended. The null hypothesis tested was that neither group would demonstrate a significant preference for retaining their hearing aids.
Measured: 6 months post-fitting

Secondary outcomes (2)

Hearing Aid Use Time (Number of Participants With an Average Hearing Aid Use Time of 4 Hours a Day)
Hearing aid use time was the number of participants who wore their hearing aids for an average of at least 4 hours per day. The average number of hours that the participants used their hearing aids was measured by their hearing aid data logging systems. These data were collected at the end of the treatment interval for each participant and were considered a positive outcome if they wore their hearing aids at least 4 hours a day on average after 1 month of use. The null hypothesis tested was that none of the participants in the three groups would not demonstrate hearing aid use time 4 hours or more, on average per day.
Measured: Hearing aid use time was collected at 6 months post-fitting.
Speech Perception in Quiet and in Noise
The participants' speech perception was measured at the word level with the California Consonant Test (CCT). The CCT is a 50 item a closed-set word identification test. It was administered at 3 timepoints (pre-fitting, 1-week post-fitting, and 6-months post-fitting), with testing was completed in quiet and in background noise (speech babble, +3 dB signal/babble) at each timepoint. The participants were unaided during the pre-fitting testing but wore their hearing aids during the two post-fitting sessions. The outcome measure was the proportion of correct trials out of 50. A correct trial consisted of an accurate identification of the target word presented to the participant in the sound-field at 40 dB sensation level. The null hypothesis tested was that speech perception would not improve over the treatment intervals for the groups for either test condition (quiet and noise).
Measured: The CCT was administered immediately pre-fitting (unaided), 1 week post-fitting (aided), and 6 months post-fitting (aided).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 201531 Dec 2020

First posted24 Apr 2014 (estimated)
Study start1 Aug 2015
Primary completion30 Nov 2020
Study completion31 Dec 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Hearing ImpairmentStudies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: The primary study was diagnostic, with a goal of better understanding and determining the best diagnostic assessment battery for capturing the hearing and auditory problems reported by blast-exposed Veterans. The secondary purpose was to implement a preliminary treatment study to determine if blast-exposed Veterans with hearing complaints, but normal audiometric data benefited from low-gain hearing aids. This secondary treatment study is the clinical trial portion of this study.
Masking: None (open label)
Enrolment: 363 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02122458
Sponsor's protocol ID: C1164-R
Status last verified: Jun 2023
First submitted: 22 Apr 2014
Last updated: 22 Jun 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes: De-identified Individual participant data and the study data dictionary will be made available upon request to the PI (spratt@pitt.edu).

Publications

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.
PubMed 28981349
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.
PubMed 23341279
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.
PubMed 32966118
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.
PubMed 21419179
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.
PubMed 32520849
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.
PubMed 28418327
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.
PubMed 23341276
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.
PubMed 20104403
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.
PubMed 34582257

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Hearing Impairment

All Hearing Impairment trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Blast-exposed Veterans With Auditory Complaints
ClinicalTrials.gov ID: NCT02122458
Acronym / sponsor ID: C1164-R
Conditions: Hearing Impairment, Hearing Aid Fitting
Keywords: hearing impairment, post-traumatic stress disorder, traumatic brain injury, auditory processing disorder
Study type: Interventional
Recruitment status: Completed
Enrolment: 363 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Study start: 1 Aug 2015 (actual)
Primary completion: 30 Nov 2020 (actual)
Study completion: 31 Dec 2020 (actual)
First posted: 24 Apr 2014 (estimated)
Results: Posted 22 Jun 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 7
Model description: The primary study was diagnostic, with a goal of better understanding and determining the best diagnostic assessment battery for capturing the hearing and auditory problems reported by blast-exposed Veterans. The secondary purpose was to implement a preliminary treatment study to determine if blast-exposed Veterans with hearing complaints, but normal audiometric data benefited from low-gain hearing aids. This secondary treatment study is the clinical trial portion of this study.

Arm	Type	Receives
Immediate Hearing Aid Treatment: Blast-exposed Only	Active comparator	Device: mild-gain hearing aids with high-frequency emphasis over 6-monthsThis 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.
Immediate Hearing Aid Treatment: Blast-exposed with PTSD	Active comparator	Device: mild-gain hearing aids with high-frequency emphasis over 6-monthsThis 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.
Delayed Hearing Aid Treatment: Blast-exposed Only	Active comparator	Device: mild-gain hearing aids with high-frequency emphasis over 6-monthsThis 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.
Non-treatment Diagnostic Testing: Normal	No intervention	–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.
Non-Treatment Diagnostic Testing: Blast-exposed Only	No intervention	–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.
Non-treatment Diagnostic Testing: Blast-exposed with PTSD	No intervention	–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.
Non-treatment Diagnostic Testing: PTSD Only	No intervention	–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.

Who may qualify

Ages: 20 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

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;

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
mild-gain hearing aids with high-frequency emphasis over 6-monthsAlso: hearing aidsopen-fit hearing aids with mild amplification in the high frequencies.	Device	Delayed Hearing Aid Treatment: Blast-exposed Only, Immediate Hearing Aid Treatment: Blast-exposed Only, Immediate Hearing Aid Treatment: Blast-exposed with PTSD

Primary outcome

Hearing Handicap Inventory for Adults (HHIA)
Time frame: The participants wore their hearing aids for 6 months-fitting (baseline to 6-months post-fitting). The delayed group had a 6-month delay prior to treatment.
Self-perceived hearing handicap was measured with the Hearing Handicap Inventory for Adults (HHIA), pre- and 6-months post-hearing aid fitting. The minimum score is 0 and the maximum score is 100, with the higher score reflecting greater handicap (worse outcome). The data are presented as a comparison between the two questionnaire administrations (pre- and 6-months post-fitting). The null hypothesis tested was that there would be no difference between the HHIA administered at baseline (pre-fitting) and 6-months post-fitting for all groups.
Hearing Aid Benefit (Abbreviated Profile of Hearing Aid Benefit, APHAB)
Time frame: The APHAB was administered 6-months post-fitting. The delayed group had a 6-month delay prior to the treatment (6-months of wearing the hearing aids).
The Abbreviated Profile of Hearing Aid Benefit (APHAB) was administered at the end of the treatment period (6-months post-fitting) to measure self-perceived benefit. The APHAB is a 24-item self-assessment inventory used to indicate the extent to which listeners experience listening difficulties (with and without hearing aids) in various settings. The questionnaire uses a 7-point scale that corresponds to the frequency with which difficulties are experienced (99 to 1% of the time). The APHAB was administered for both unaided listening and aided listening, and benefit was calculated by subtracting the mean aided scores from the mean unaided scores. Higher benefit scores (e.g., 99% unaided - 25% aided vs. 99% unaided - 50% aided) reflected greater benefit (better outcome) and negative scores were possible. The null hypothesis tested was that no hearing aid benefit would be demonstrated by any of the 3 groups at 6-months post-fitting.
Intent to Continue Use
Time frame: 6 months post-fitting
The participants reported whether they would continue to use their hearing aids after the study has ended. The null hypothesis tested was that neither group would demonstrate a significant preference for retaining their hearing aids.

2 secondary outcomes

Hearing Aid Use Time (Number of Participants With an Average Hearing Aid Use Time of 4 Hours a Day)
Time frame: Hearing aid use time was collected at 6 months post-fitting.
Speech Perception in Quiet and in Noise
Time frame: The CCT was administered immediately pre-fitting (unaided), 1 week post-fitting (aided), and 6 months post-fitting (aided).

Results and safety

Results posted to the registry on 22 Jun 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Immediate Hearing Aid Treatment: Blast-exposed Only	12	9
Immediate Hearing Aid Treatment: Blast-exposed With PTSD	18	13
Delayed Hearing Aid Treatment: Blast-exposed Only	7	7
Non-treatment Diagnostic Testing: Normal	82	67
Non-treatment Diagnostic Testing: Blast-exposed Only	45	31
Non-treatment Diagnostic Testing: Blast-exposed With PTSD	43	23
Non-treatment Diagnostic Testing: PTSD Only	19	18

Primary outcome: Hearing Handicap Inventory for Adults (HHIA)

Time frame: The participants wore their hearing aids for 6 months-fitting (baseline to 6-months post-fitting). The delayed group had a 6-month delay prior to treatment.. Mean (95% Confidence Interval). Unit: Scale score

Measure	Immediate Hearing Aid Treatment: Blast-exposed Only n = 9	Immediate Hearing Aid Treatment: Blast-exposed With PTSD n = 13	Delayed Hearing Aid Treatment: Blast-exposed Only n = 7
Value	26.20 (19.04 to 33.33)	37.34 (31.37 to 43.32)	19.21 (10.48 to 27.95)

Immediate Hearing Aid Treatment: Blast-exposed Only vs Immediate Hearing Aid Treatment: Blast-exposed With PTSD vs Delayed Hearing Aid Treatment: Blast-exposed Only: Mean Difference (Net): .448 (95% CI -8.66 to 9.56), p = .05, Mixed Models Analysis

Population analysed: A total of 37 participants were recruited to enroll in the treatment (clinical trial) part of the study. Eight of these 37 participants did not complete the treatment. The handicap scale was administered twice (pre-fitting and 6-months post-fitting) to the three groups. The Outcome Measure Data Table reflect comparisons between the overall scores for the 2 questionnaire administrations.

Primary outcome: Hearing Aid Benefit (Abbreviated Profile of Hearing Aid Benefit, APHAB)

Time frame: The APHAB was administered 6-months post-fitting. The delayed group had a 6-month delay prior to the treatment (6-months of wearing the hearing aids).. Mean (Standard Deviation). Unit: Scale score

Measure	Immediate Hearing Aid Treatment: Blast-Exposed Only n = 9	Immediate Hearing Aid Treatment: Blast-exposed With PTSD n = 13	Delayed Hearing Aid Treatment: Blast-exposed Only n = 7
Value	-.362 (.301)	-.270 (.821)	-.080 (.331)

Immediate Hearing Aid Treatment: Blast-Exposed Only vs Immediate Hearing Aid Treatment: Blast-exposed With PTSD vs Delayed Hearing Aid Treatment: Blast-exposed Only: p = .05, ANOVA

Population analysed: A total of 37 participants were recruited to enroll in the treatment (clinical trial) part of the study. Eight of these 36 participants did not complete the treatment. The APHAB benefit data shown here were collected at 6-months post-fitting (end of the treatment) from the 3 groups of participants. One APHAB (aided and unaided portions) was completed per participant.

Primary outcome: Intent to Continue Use

Time frame: 6 months post-fitting. Count of participants. Unit: Participants

Measure	Immediate Hearing Aid Treatment: Blast-Exposed Only n = 9	Immediate Hearing Aid Treatment: Blast-Exposed With PTSD n = 13	Delayed Hearing Aid Treatment: Blast-exposed Only n = 7
Value	9	13	7

Population analysed: A total of 37 participants were recruited to enroll in the treatment (clinical trial) part of the study. Eight of these 36 participants did not complete the treatment. The data shown here were collected at 6-months post-fitting (end of the treatment) from the 3 groups of participants.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were queried for each individual participant per session from enrollment to completion of their participation in study and summarized yearly at IRB renewal, Adverse Events were collected for 6 months from all participants except for those enrolled in the Delayed Hearing Aid Treatment Arm/Group, which was assessed for up to 1 year.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Immediate Hearing Aid Treatment: Blast-exposed Only	1 of 12 (8.3%)	0 of 12 (0%)	0 of 12
Immediate Hearing Aid Treatment: Blast-exposed With PTSD	0 of 18 (0%)	0 of 18 (0%)	0 of 18
Delayed Hearing Aid Treatment: Blast-exposed Only	0 of 7 (0%)	0 of 7 (0%)	0 of 7
Non-treatment Diagnostic Testing: Normal	0 of 82 (0%)	0 of 82 (0%)	0 of 82
Non-treatment Diagnostic Testing: Blast-exposed Only	0 of 45 (0%)	0 of 45 (0%)	0 of 45
Non-treatment Diagnostic Testing: Blast-exposed With PTSD	0 of 43 (0%)	0 of 43 (0%)	0 of 43
Non-treatment Diagnostic Testing: PTSD Only	0 of 19 (0%)	0 of 19 (0%)	0 of 19

Limitations and caveats (from the sponsor): The hearing aid treatment portion of this study was preliminary in nature and limited by the number of participants enrolled and amount of time with which those enrolled wore their hearing aids. Problems with hearing aid wear-time compliance limited interpretation and applicability.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 28981349Gallun 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.
Background: PubMed 23341279Gallun 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.
Background: PubMed 32966118Koerner 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.
Background: PubMed 21419179Folmer 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.
Background: PubMed 32520849Papesh 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.
Background: PubMed 28418327Hoover 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.
Background: PubMed 23341276Gallun 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.
Background: PubMed 20104403Fausti 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.
Background: PubMed 34582257Reavis 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.
Individual participant dataSharing planned: Yes. De-identified Individual participant data and the study data dictionary will be made available upon request to the PI (spratt@pitt.edu).

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Hearing Impairment

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sheila R Pratt, PhD principal investigator

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hearing Handicap Inventory for Adults (HHIA) (time frame: The participants wore their hearing aids for 6 months-fitting (baseline to 6-months post-fitting). The delayed group had a 6-month delay prior to treatment.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02122458, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023; AzTrials last refreshed its copy on 27 Oct 2026.