Blast Exposed Veterans With Auditory Complaints

Hearing Impairment Clinical Trial

Official title:

Blast-exposed Veterans With Auditory Complaints

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02122458
• Other study ID #: C1164-R
• Status: Completed
• Phase: N/A
• Start date: August 1, 2015
• Est. completion date: December 31, 2020

Study information

• Verified date: June 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 363
• Est. completion date: December 31, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Deafness
• Hearing Aid Fitting
• Hearing Impairment
• Hearing Loss

Intervention

Device:
• mild-gain hearing aids with high-frequency emphasis over 6-months
open-fit hearing aids with mild amplification in the high frequencies.

Locations

Country	Name	City	State
United States	VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA	Pittsburgh	Pennsylvania
United States	VA Portland Health Care System, Portland, OR	Portland	Oregon
United States	Sioux Falls VA Health Care System, Sioux Falls, SD	Sioux Falls	South Dakota

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.
Primary	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.	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).
Primary	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.	6 months post-fitting
Secondary	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.	Hearing aid use time was collected at 6 months post-fitting.
Secondary	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).	The CCT was administered immediately pre-fitting (unaided), 1 week post-fitting (aided), and 6 months post-fitting (aided).