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Central Auditory Processing Deficits Associated With Blast Exposure

19 de marzo de 2019 actualizado por: VA Office of Research and Development
The current conflicts in Afghanistan and Iraq have resulted in unprecedented rates of exposure to high-intensity blasts and resulting brain injury. This research team has established that recently blast-exposed Soldiers show differences from controls on tests of central auditory function. This project will 1) develop a more accurate estimate of the prevalence of central auditory dysfunction among Veterans exposed to blasts over the past ten years, 2) identify the functional outcomes associated with abnormal performance on tests of central processing, and 3) improve understanding of the ways in which blast-exposure resembles and differs from both the normal aging process and non-blast-related TBI in terms of performance on tests of central auditory processing.

Descripción general del estudio

Estado

Terminado

Intervención / Tratamiento

Descripción detallada

The current conflicts in Afghanistan (Operation Enduring Freedom; OEF) and Iraq (Operation Iraqi Freedom; OIF) have resulted in unprecedented rates of exposure to high-intensity blasts and resulting brain injury. Dennis (2009) reports that during 2005-2007, 68% of U.S. military personnel injured in the OEF/OIF conflicts had blast-related injuries and 28%-31% of those evacuated to Walter Reed Army Medical Center (WRAMC), Washington, DC had brain injuries. While the common focus of auditory evaluation is on damage to the peripheral auditory system, the prevalence of brain injury among those exposed to high-intensity blasts suggests that damage to the central auditory system is an equally important concern for the blast-exposed Veteran. Discussions with clinical audiologists and OEF/OIF Veterans Service Office personnel suggest that a common complaint voiced by blast-exposed Veterans is an inability to understand speech in noisy environments, even when peripheral hearing is within normal or near-normal limits (see attached letters of support). Such complaints are consistent with damage to neural networks responsible for higher-order auditory processing. This proposal is the second phase of a research project focused on examining the degree to which central auditory processing (CAP) dysfunction is a result of blast exposure. Over the initial period of funding, data collection at WRAMC and the VA RR&D National Center for Rehabilitative Auditory Research (NCRAR) established that CAP dysfunction is present in Warfighters exposed to high-intensity blasts while serving in combat. Recently blast-exposed patients with and without diagnoses of mild traumatic brain injury (mTBI) tested at WRAMC showed differences from controls tested at NCRAR on one or more behavioral and neurophysiological tests used to evaluate central auditory function. This project will 1) develop a more accurate estimate of the prevalence of central auditory dysfunction among Veterans exposed to blasts over the past ten years, 2) identify the functional outcomes associated with abnormal performance on tests of central processing, and 3) improve understanding of the ways in which blast-exposure resembles and differs from both the normal aging process and non-blast-related TBI in terms of performance on tests of central auditory processing.

Key Question 1: To what extent is CAP dysfunction observable among OEF/OIF Veterans who have been exposed to high intensity blasts? Based on preliminary data, the investigators hypothesize that the rate of abnormal performance on behavioral and neurophysiological tests of CAP dysfunction will be higher in a group of Veterans exposed to blasts than it will be in a control group of similar ages and hearing thresholds who have not been exposed to blasts.

Key Question 2: How well can behavioral and neurophysiological tests of CAP predict functional auditory deficits measured behaviorally and through self report? It is hypothesized that tests of CAP ability will predict performance in a testing situation involving multiple talkers delivering competing messages. CAP tests will also correlate with responses blast-exposed Veterans make on the Speech and Spatial Qualities of Hearing (SSQ) questionnaire, designed to examine functional hearing ability in various acoustically complex environments.

Key Question 3: To what extent do blast-exposed Veterans resemble older listeners and participants with mild TBI who have not been exposed to blasts in their performance on CAP tests and functional tests of hearing? It is hypothesized that comparisons of the blast-exposed group with an older group with matched pure-tone sensitivity and an age- and hearing-matched group with non-blast-related TBI will be consistent with premature aging in the blast-exposed group but demonstrate substantive differences with the non-blast group.

Tipo de estudio

De observación

Inscripción (Actual)

105

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Oregon
      • Portland, Oregon, Estados Unidos, 97239
        • VA Portland Health Care System, Portland, OR

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 90 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

community sample

Descripción

Inclusion Criteria:

  • Aged 18-90
  • Pure-tone sensitivity of 40 dB HL or better at all audiometric frequencies below 8 kHz
  • English as first language.

Group membership inclusion criteria:

Group 1: Blast exposed Veterans

  • Report having been exposed to high-intensity blast during the ten years prior to enrollment
  • Cognitive and physical ability to take part in these auditory evaluations

Group 2. Non-blast TBI group

  • Diagnosed with mild-to-moderate TBI

Group 3. Age matched control group -18-59 years.

Group 4. Older control group

  • 60-90 years.
  • Older group will be aged 60 and older

Audiometric status of these groups will be required to meet the same exclusion criteria as that of the other two groups described above

Exclusion Criteria:

  • Evidence of conductive or retrocochlear dysfunction
  • Hearing loss exceeding pure-tone averages for frequencies of .5, 1, 2, and 4 kHz of 35 dB HL

    --Hearing loss of greater than 40 dB HL at any one of these frequencies in either ear

  • Asymmetrical hearing thresholds exceeding 10 dB at any audiometric frequency below 4 kHz
  • Abnormal cognitive function as indicated by scores of 23 or below on the Mini Mental State Exam
  • Indications of clinical depression as evidenced by a score of 17 or greater on the Beck Depression Inventory

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Modelos observacionales: Control de caso
  • Perspectivas temporales: Futuro

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
Control
Non-blast-exposed and non-TBI, aged younger than 50
All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities.
Blast
Blast-exposed with or without a TBI diagnosis
All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities.
Non-Blast-Exposed TBI
Non-blast-exposed with TBI diagnosis
All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities.
Older
Non-blast-exposed and non-TBI, aged 50 or older
All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Blast-exposed Veterans With Abnormal Abilities in One or More Behavioral Tests of Central Auditory Processing
Periodo de tiempo: six months

Tests to be administered:

Dichotic Digits Test: Percentage of digits reported correctly from 0 (worst performance) to 100 (best performance) Gaps in Noise Test: Approximate threshold in milliseconds from 2 (best) to 20 (worst) Staggered Spondaic Words Test: Total number of errors from 0 (best) to 40 (worst) Masking Level Differences Test: Difference in threshold between diotic and dichotic stimuli in decibels from 0 (worst) to 24 (best) Frequency Pattern Test: Percentage of sequences reported correctly from 0 (worst performance) to 100 (best performance) Adaptive Tests of Temporal Resolution: Not reported due to software error in stimulus presentation

six months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Ratings of Self-reported Ability to Process Auditory Information in Various Settings
Periodo de tiempo: six months
Hearing Health Inventory for Adults is a 25 item questionnaire that asks participants to rank how often auditory issues create problems in daily life. Scores range from 0 to 100, with higher scores indicating greater perceived levels of handicap.
six months
Functional Hearing Ability in Multitalker Environments
Periodo de tiempo: six months
The Functional Hearing Questionnaire (FHQ), developed for veterans with brain injuries was used to evaluate self perceived hearing difficulties. The FHQ is a nine item questionnaire that asks participants to rate their level of difficulty hearing in different circumstances on a four point scale. Scores range from 9 to 36, with higher scores indicating a greater level of difficulty.
six months
Percent Change in P2 Component of Electrophysiological Response
Periodo de tiempo: six months
Average change in amplitude of the P2 component of the electrophysiological response to paired clicks. Habituation to the clicks is anticipated, resulting in a large percentage change in amplitude to the second click.
six months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Frederick J Gallun, PhD, VA Portland Health Care System, Portland, OR

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de mayo de 2012

Finalización primaria (Actual)

1 de diciembre de 2015

Finalización del estudio (Actual)

1 de diciembre de 2015

Fechas de registro del estudio

Enviado por primera vez

2 de marzo de 2012

Primero enviado que cumplió con los criterios de control de calidad

27 de marzo de 2012

Publicado por primera vez (Estimar)

30 de marzo de 2012

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

14 de junio de 2019

Última actualización enviada que cumplió con los criterios de control de calidad

19 de marzo de 2019

Última verificación

1 de marzo de 2019

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

Descripción del plan IPD

Data sharing will be through an established data repository overseen by the VA Portland HCS IRB.

Marco de tiempo para compartir IPD

Available starting Jan 2016, and continuing to be available as long as a repository director is available to oversee the data.

Criterios de acceso compartido de IPD

IRB approved protocol allowing data to be transferred from repository to recipient study.

Tipo de información de apoyo para compartir IPD

  • Código analítico

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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