Audiological Rehabilitation of Children With Unilateral Hearing Loss (SHINE)
The goal of this study is to examine the effects of hearing aids and early intervention on hearing, language, and neural development in children with hearing loss in one ear, known as unilateral hearing loss. The main research questions are:
- Do children with unilateral hearing loss with earlier access to hearing aids and early intervention have better speech understanding in noise than children with unilateral hearing loss with later or no access to intervention?
- Do children with unilateral hearing loss with earlier access to intervention have more typical responses in the brain than children with late or no access to intervention?
- Do children with unilateral hearing loss with earlier access to intervention have better speech and language skills than children with late or no access to intervention?
Researchers will collect hearing, language, and neural data and information about each child's access to intervention to examine the longitudinal impact of auditory experience on these outcomes.
Participants and their caregivers will:
- Answer questions about the child's health, developmental, and hearing histories.
- Receive hearing tests and speech recognition tests.
- Complete tests of speech and language abilities.
- A subset of eligible participants will undergo magnetic resonance imaging (MRI) and magneotencephalography (MEG).
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
More than 5 million children in the United States have hearing loss in one ear, known as unilateral hearing loss (UHL). The primary consequence of UHL is reduced spatial hearing, which is crucial for communication and functioning in everyday listening conditions. Children with UHL (CUHL) are at risk for delays in language and academic outcomes compared to peers with normal hearing in both ears. However, there are large individual differences in developmental outcomes that cannot be explained by the degree of hearing loss in the affected ear. CUHL also have a wide range of spatial hearing abilities, and there is currently limited evidence to link individual differences in spatial hearing to the wide range of developmental outcomes that are observed in CUHL. The lack of predictable patterns of risk for CUHL leads to inconsistent recommendations for audiological intervention or intervention that commences only after a child demonstrates fails to progress in language or academic outcomes. Audiologists have the option to improve spatial hearing in CUHL through fitting a hearing aid on the affected ear, but hearing aids are often not provided or are only provided at later ages, even when UHL is identified in the first few months of life. The lack of consistent practices around provision of hearing aids for CUHL is due to limited evidence that hearing aids can support binaural processing in CUHL. This project seeks to provide mechanistic evidence to support earlier and more timely intervention for CUHL. Researchers will use a metric referred to as auditory dosage to quantify auditory input to the affected ear based on aided and unaided speech audibility and consistency of hearing aid use. Auditory dosage is expected to be the primary predictor of individual differences in outcomes for CUHL. The core hypothesis of the proposal is that CUHL who have higher auditory dosage in their affected ear will have better spatial hearing, which in turn leads to better language and academic outcomes than peers with lower auditory dosage in their affected ear. Experiments will combine behavioral and neuroimaging measures of spatial hearing with and without amplification to assess how auditory dosage in the affected ear influences spatial hearing, language, and academic outcomes in CUHL. Researchers will analyze the effects of hearing aid distortion and auditory dosage on behavioral measures of spatial hearing with and without amplification. Structural and functional neuroimaging, including magnetoencephalography and magnetic resonance imaging, will be used to assess the impact of auditory dosage on spatial hearing in CUHL. The study will use an accelerated longitudinal design to assess the mediating effects of spatial hearing on the association between hearing aid distortion and auditory dosage and language and academic outcomes in CUHL. These experiments will provide mechanistic evidence to help guide decisions about audiological intervention for CUHL and lead to individualized interventions to improve spatial hearing, language, and academic outcomes for CUHL.
Tipo de estudio
Tipo de estudio
Inscripción (Estimado)
Inscripción
Contactos y Ubicaciones
Estudio Contacto
Estudio Contacto
- Nombre: Ryan McCreery, PhD
- Número de teléfono: 531-355-6668
- Correo electrónico: Ryan.McCreery@boystown.org
Copia de seguridad de contactos de estudio
- Nombre: Amanda Knihal
- Número de teléfono: 531-355-6533
- Correo electrónico: Amanda.Knihal@boystown.org
Ubicaciones de estudio
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Iowa
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Iowa City, Iowa, Estados Unidos, 52242
- Aún no reclutando
- University of Iowa
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Contacto:
- Wendy Fick
- Número de teléfono: 319-335-8749
- Correo electrónico: wendy-fick@uiowa.edu
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Investigador principal:
- Elizabeth Walker, PhD
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Nebraska
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Omaha, Nebraska, Estados Unidos, 68131
- Reclutamiento
- Boys Town National Research Hospital
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Contacto:
- Amanda Knihal
- Número de teléfono: 531-355-6533
- Correo electrónico: Amanda.Knihal@boystown.org
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Investigador principal:
- Ryan McCreery, PhD
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Sub-Investigador:
- Nicole Corbin, PhD
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Sub-Investigador:
- Dawna Lewis, PhD
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North Carolina
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Chapell Hill, North Carolina, Estados Unidos, 27599
- Aún no reclutando
- University of North Carolina, Chapell Hill
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Contacto:
- Caitlin Sapp, PhD
- Número de teléfono: 984-974-4479
- Correo electrónico: Caitlin.Sapp@unchealth.unc.edu
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Investigador principal:
- Emily Buss, PhD
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Sub-Investigador:
- Caitlin Sapp, PhD
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Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Children with normal hearing and children with unilateral hearing loss will be recruited from hospitals, audiology clinics, and education agencies across the United States.
Descripción
Inclusion Criteria:
- Children with normal hearing will have hearing thresholds from 0.25 - 8 kHz ≤15 dB HL in both ears.
- Children with normal hearing will have no history of neurodevelopmental, communication, or sensory disorders.
- Children with unilateral hearing loss will have hearing thresholds that meet the criterion for CNH in the better ear and three-frequency (.5, 1, & 2 kHz) pure-tone average ≥ 20 - <70 dB HL or two or more hearing thresholds ≥ 20 - < 70 dB HL from 2-8 kHz in the poorer ear. H
- Children with unilateral hearing loss can have conductive, mixed, or sensorineural hearing loss.
Exclusion Criteria:
- Individuals with a cochlear implant, rerouting device, or an implanted bone conduction device will be excluded due to neuroimaging restrictions with implantable devices.
- For neuroimaging experiments only:
- Current use of the following medications: psychotropic medications or other medications with significant CNS effects (e.g., antidepressants, antipsychotics, anticonvulsants, alpha-agonists, adrenergic blockers, lithium, and sedating antihistamines), or other excluded medication.
- Current major psychiatric diagnosis.
- Current substance abuse or substance dependence.
- Diagnosis of a known neurological disorder or any major medical illness or injury impacting neurological/psychiatric function (e.g., diabetes, epilepsy, cerebral palsy, HIV, traumatic brain injury, significant environmental/toxic injury, neurodegenerative disorder, past meningitis/encephalitis).
- General medical conditions: any major medical conditions that would interfere with involvement in the study or may affect CNS function as judged by the investigative team.
- Presence of any ferrous metal implant, including orthodonture or pacemaker, which may interfere with the MEG data acquisition and/or be an MRI safety concern.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
Número de grupos/cohortes
Cohortes e Intervenciones
Grupo / CohorteGrupo / Cohorte |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
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Unilateral hearing loss
Children with unilateral hearing loss with hearing aids and children with unilateral hearing loss without hearing aids. |
Hearing aids amplify acoustic sound to provide access to acoustic cues for communication and spatial hearing. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Spatial release from masking
Periodo de tiempo: At enrollment
|
Spatial release from masking is the difference in the speech recognition threshold for 50% sentence keyword recognition in decibels when a target talker and masker are co-located compared to when the target and masker are spatially separated. |
At enrollment
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Morphosyntax
Periodo de tiempo: At enrollment, 12 months after enrollment and 24 months after enrollment.
|
Morphosyntax is the combination of morphology (the internal structure of words) and syntax (the rules for arranging words into sentences), which quantifies how word forms and sentence structures work together to encode meaning. Morphosyntax will be measured using the Comprehensive Assessment of Spoken Language (CASL) Grammatical Morphemes subtest. This standardized instrument has a range from 0 - 20 with an average score of 10. The proportion of children with unilateral hearing loss who fall within the range of children with typical bilateral hearing matched for age and nonverbal intelligence will be compared. |
At enrollment, 12 months after enrollment and 24 months after enrollment.
|
Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Localization
Periodo de tiempo: At enrollment
|
Localization is the ability to identify the direction that a sound originates in the horizontal plane without visual cues. Localization will be measured in sound field in an 11-speaker array where the child must identify the azimuth of sounds presented from different locations. Localization errors are calculated as the difference in degrees between the child's indicated location and the location where the sound is presented. The range of errors can be 0 - 180 degrees. Children with unilateral hearing loss will be compared to children with typical bilateral hearing. |
At enrollment
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Vocabulary
Periodo de tiempo: At enrollment, 12 months after enrollment, and 24 months after enrollment.
|
Vocabulary is the ability to understand and use word meaning. Vocabulary will be measured using the The Test of Integrated Language and Literacy Skills (TILLS) Vocabulary Awareness subtest. The subtest has a range of 0 - 20 with a mean score of 10. The proportion of children with unilateral hearing loss who fall within the range of children with typical bilateral hearing matched for age and nonverbal intelligence will be compared. |
At enrollment, 12 months after enrollment, and 24 months after enrollment.
|
Colaboradores e Investigadores
Patrocinador
Patrocinador
Colaboradores
Colaboradores
Investigadores
Investigadores
- Investigador principal: Ryan McCreery, PhD, Father Flanagan's Boys' Home
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Inicio del estudio
Finalización primaria (Estimado)
Finalización primaria
Finalización del estudio (Estimado)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Manifestaciones neurológicas
- Enfermedades del Sistema Nervioso
- Enfermedades Otorrinolaringológicas
- Trastornos sensoriales
- Enfermedades del oído
- Pérdida de la audición
- Trastornos de la audición
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Pérdida Auditiva, Unilateral
- Equipos y suministros
- Equipos y suministros eléctricos
- Dispositivos electrónicos portátiles
- Ayudas sensoriales
- Audífonos
Otros números de identificación del estudio
Otros números de identificación del estudio
- R01DC023371 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
All IPD will be shared.
Marco de tiempo para compartir IPD
The study protocol, statistical analysis plan, and informed consent forms will be made available at the beginning of the study. The analytic code will be made available as soon as data analysis commences. These will be made available via the project registry and will be maintained until 5 years after the study end date.
Criterios de acceso compartido de IPD
The IPD will be publicly available through a repository.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- CÓDIGO_ANALÍTICO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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