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).
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
등록 (추정된)
등록
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Ryan McCreery, PhD
- 전화번호: 531-355-6668
- 이메일: Ryan.McCreery@boystown.org
연구 연락처 백업
- 이름: Amanda Knihal
- 전화번호: 531-355-6533
- 이메일: Amanda.Knihal@boystown.org
연구 장소
-
-
Iowa
-
Iowa City, Iowa, 미국, 52242
- 아직 모집하지 않음
- University of Iowa
-
연락하다:
- Wendy Fick
- 전화번호: 319-335-8749
- 이메일: wendy-fick@uiowa.edu
-
수석 연구원:
- Elizabeth Walker, PhD
-
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Nebraska
-
Omaha, Nebraska, 미국, 68131
- 모병
- Boys Town National Research Hospital
-
연락하다:
- Amanda Knihal
- 전화번호: 531-355-6533
- 이메일: Amanda.Knihal@boystown.org
-
수석 연구원:
- Ryan McCreery, PhD
-
부수사관:
- Nicole Corbin, PhD
-
부수사관:
- Dawna Lewis, PhD
-
-
North Carolina
-
Chapell Hill, North Carolina, 미국, 27599
- 아직 모집하지 않음
- University of North Carolina, Chapell Hill
-
연락하다:
- Caitlin Sapp, PhD
- 전화번호: 984-974-4479
- 이메일: Caitlin.Sapp@unchealth.unc.edu
-
수석 연구원:
- Emily Buss, PhD
-
부수사관:
- Caitlin Sapp, PhD
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Children with normal hearing and children with unilateral hearing loss will be recruited from hospitals, audiology clinics, and education agencies across the United States.
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: PROSPECTIVE
그룹/코호트 수
코호트 및 개입
그룹/코호트그룹/코호트 |
개입 / 치료개입 / 치료 |
|---|---|
|
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. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Spatial release from masking
기간: 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
|
|
Morphosyntax
기간: 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.
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Localization
기간: 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
|
|
Vocabulary
기간: 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.
|
공동 작업자 및 조사자
협력자
협력자
수사관
수사관
- 수석 연구원: Ryan McCreery, PhD, Father Flanagan's Boys' Home
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- R01DC023371 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
All IPD will be shared.
IPD 공유 기간
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.
IPD 공유 액세스 기준
The IPD will be publicly available through a repository.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- ANALYTIC_CODE
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .