Blast Exposed Veterans With Auditory Complaints

NCT02122458 | Completed Results FDA Device

• 1 other identifier: C1164-R
• Study Type: interventional
• Target: 363
• Locations: 1 country
• Sites: 3

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.

Conditions

Hearing Impairment; Hearing Aid Fitting

Keywords

hearing impairment; post-traumatic stress disorder; traumatic brain injury; auditory processing disorder

Outcome Measures

Primary Outcomes (3)

• 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.

• 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).

• 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 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 collected at 6 months post-fitting.

• Speech Perception in Quiet and in Noise

  The CCT was administered immediately pre-fitting (unaided), 1 week post-fitting (aided), and 6 months post-fitting (aided).

Study Arms (7)

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.

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.

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.

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.

Interventions

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

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

Also known as: hearing aids

Delayed Hearing Aid Treatment: Blast-exposed Only; Immediate Hearing Aid Treatment: Blast-exposed Only; Immediate Hearing Aid Treatment: Blast-exposed with PTSD

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (3)

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97239, United States

Location

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, 15240, United States

Location

Sioux Falls VA Health Care System, Sioux Falls, SD

Sioux Falls, South Dakota, 57117-5046, United States

Location

Related Publications (9)

• 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.

  PMID: 28981349 BACKGROUND

• 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.

  PMID: 23341279 BACKGROUND

• 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.

  PMID: 32966118 BACKGROUND

• 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.

  PMID: 21419179 BACKGROUND

• 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.

  PMID: 32520849 BACKGROUND

• 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.

  PMID: 28418327 BACKGROUND

• 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.

  PMID: 23341276 BACKGROUND

• 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.

  PMID: 20104403 BACKGROUND

• 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.

  PMID: 34582257 BACKGROUND

MeSH Terms

Conditions

Hearing Loss; Stress Disorders, Post-Traumatic; Brain Injuries, Traumatic; Auditory Perceptual Disorders

Interventions

Hearing Aids

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Auditory Diseases, Central; Retrocochlear Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Cognition Disorders; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Wearable Electronic Devices; Electrical Equipment and Supplies; Equipment and Supplies; Sensory Aids

Limitations and Caveats

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.

Results Point of Contact

• Title: Sheila R. Pratt, Ph.D.
• Organization: VA Pittsburgh Healthcare System

Sheila.Pratt@va.gov

412-979-3157

Study Officials

• Sheila R Pratt, PhD

  VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 22, 2014
• First Posted: April 24, 2014
• Study Start: August 1, 2015
• Primary Completion: November 30, 2020
• Study Completion: December 31, 2020
• Last Updated: June 22, 2023
• Results First Posted: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available at the conclusion of the study and after publication of planned study manuscripts. The time will not be limited.
• Access Criteria: Those requesting data will need to provide a plan for how the data will be used.

Locations

US (3)