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. Our 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).
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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. We 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. We anticipate auditory dosage is 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. We 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. We will also 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 di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Ryan McCreery, PhD
- Numero di telefono: 531-355-6668
- Email: Ryan.McCreery@boystown.org
Backup dei contatti dello studio
- Nome: Amanda Knihal
- Numero di telefono: 531-355-6533
- Email: Amanda.Knihal@boystown.org
Luoghi di studio
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Iowa
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Iowa City, Iowa, Stati Uniti, 52242
- Non ancora reclutamento
- University of Iowa
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Contatto:
- Wendy Fick
- Numero di telefono: 319-335-8749
- Email: wendy-fick@uiowa.edu
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Investigatore principale:
- Elizabeth Walker, PhD
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Nebraska
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Omaha, Nebraska, Stati Uniti, 68131
- Reclutamento
- Boys Town National Research Hospital
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Contatto:
- Amanda Knihal
- Numero di telefono: 531-355-6533
- Email: Amanda.Knihal@boystown.org
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Investigatore principale:
- Ryan McCreery, PhD
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Sub-investigatore:
- Nicole Corbin, PhD
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Sub-investigatore:
- Dawna Lewis, PhD
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North Carolina
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Chapell Hill, North Carolina, Stati Uniti, 27599
- Non ancora reclutamento
- University of North Carolina, Chapell Hill
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Contatto:
- Caitlin Sapp, PhD
- Numero di telefono: 984-974-4479
- Email: Caitlin.Sapp@unchealth.unc.edu
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Investigatore principale:
- Emily Buss, PhD
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Sub-investigatore:
- Caitlin Sapp, PhD
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Children with normal hearing and children with unilateral hearing loss will be recruited from hospitals, audiology clinics, and education agencies across the United States.
Descrizione
Inclusion Criteria:
- Children with normal hearing will have hearing thresholds from 0.25 - 8 kHz ≤15 dB HL in both ears with 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. Hearing loss can be conductive, mixed, or sensorineural.
Exclusion Criteria:
- Children with unilateral hearing loss who have 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, there are additional exclusion criteria. Participants will be excluded from MEG and MRI experiments if they have 1) 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, 2) current major psychiatric diagnosis, 3) current substance abuse or substance dependence at any time, 4) 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) 5) 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 or 6) 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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: COHORT
- Prospettive temporali: PROSPECTIVE
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Spatial release from masking
Lasso di tempo: At enrollment
|
Spatial release from masking is the difference in the speech recognition threshold when a target talker and masker are co-located and when the target and masker are spatially separated. |
At enrollment
|
|
Morphosyntax
Lasso di tempo: 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 |
At enrollment, 12 months after enrollment and 24 months after enrollment.
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Localization
Lasso di tempo: At enrollment
|
Localization is the ability to identify the direction that a sound originates in the horizontal plane without visual cues. |
At enrollment
|
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Vocabulary
Lasso di tempo: At enrollment, 12 months after enrollment, and 24 months after enrollment.
|
Vocabulary is the ability to understand and use word meaning. |
At enrollment, 12 months after enrollment, and 24 months after enrollment.
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Ryan McCreery, PhD, Father Flanagan's Boys' Home
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Manifestazioni neurologiche
- Malattie del sistema nervoso
- Malattie otorinolaringoiatriche
- Disturbi della sensibilità
- Malattie dell'orecchio
- Perdita dell'udito
- Disturbi dell'udito
- Condizioni patologiche, segni e sintomi
- Segni e sintomi
- Perdita dell'udito, unilaterale
- Attrezzatura e forniture
- Apparecchiature elettriche e forniture
- Dispositivi elettronici indossabili
- Aiuti sensoriali
- Apparecchi acustici
Altri numeri di identificazione dello studio
- R01DC023371 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
All IPD will be shared.
Periodo di condivisione 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.
Criteri di accesso alla condivisione IPD
The IPD will be publicly available through a repository.
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- ICF
- CODICE_ANALITICO
Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .