Audiological Rehabilitation of Children With Unilateral Hearing Loss (SHINE)

November 3, 2026 updated by: Father Flanagan's Boys' Home

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:

  1. 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?
  2. 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?
  3. 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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Not yet recruiting
        • University of Iowa
        • Contact:
        • Principal Investigator:
          • Elizabeth Walker, PhD
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Recruiting
        • Boys Town National Research Hospital
        • Contact:
        • Principal Investigator:
          • Ryan McCreery, PhD
        • Sub-Investigator:
          • Nicole Corbin, PhD
        • Sub-Investigator:
          • Dawna Lewis, PhD
    • North Carolina
      • Chapell Hill, North Carolina, United States, 27599
        • Not yet recruiting
        • University of North Carolina, Chapell Hill
        • Contact:
        • Principal Investigator:
          • Emily Buss, PhD
        • Sub-Investigator:
          • Caitlin Sapp, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 years to 16 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children with normal hearing and children with unilateral hearing loss will be recruited from hospitals, audiology clinics, and education agencies across the United States.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: COHORT
  • Time Perspectives: PROSPECTIVE

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Unilateral hearing loss

Children with unilateral hearing loss with hearing aids and children with unilateral hearing loss without hearing aids.
Device: hearing aids

Hearing aids amplify acoustic sound to provide access to acoustic cues for communication and spatial hearing.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Spatial release from masking
Time Frame: 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
Time Frame: 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.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Localization
Time Frame: 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
Time Frame: 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Father Flanagan's Boys' Home

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Iowa
University of North Carolina, Chapel Hill
National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ryan McCreery, PhD, Father Flanagan's Boys' Home

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2031

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 27, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 27, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 3, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R01DC023371 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD will be shared.

IPD Sharing Time Frame

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 Sharing Access Criteria

The IPD will be publicly available through a repository.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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