Bilateral Sensorineural Hearing LossNCT05962359
Neural Prediction to Enhance Language
A study testing Parent-Implemented Communication Treatment in people with Bilateral Sensorineural Hearing Loss and Speech and Language Development Delay Due to Hearing Loss, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
Trial summary
The language outcome of children receiving cochlear implantation to address bilateral sensorineural hearing loss is more variable than that of typical hearing children. The research is focused upon development of neural predictive models based upon brain imaging to forecast language after cochlear implantation on the… Read more about this study
- Who is it for?
- Ages 0 months to 5 years
- Conditions the study is for
- Bilateral Sensorineural Hearing Loss, Speech and Language Development Delay Due to Hearing Loss, Social Communication
- What is being tested?
- Parent-Implemented Communication Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2023to 23 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with sensorineural hearing loss who meet clinical criteria for cochlear implantation in both ears who meet the following age criteria at time cochlear implant evaluation begins:
- Age 5 years and under.
- English or Spanish as the dominant language.
- English or Spanish dominant language in the home.
- Children with bilateral sensorineural hearing loss who meet clinical criterial for cochlear implantation
- English dominant spoken language by family
Show all 9Show fewer
- Age at implantation of 36 months and younger when treatment begins
- Parent or caregiver that is willing to participate who understands spoken English
- Child is exposed to spoken language by at least one parent (total communication or auditory/oral) in the home
Who cannot join
- Severe motor and /or cognitive disability that would preclude evaluation of progress
- Limited electrode insertion likely to significantly impact development of speech perception
- Hearing loss due to bacterial meningitis
- Neither English or Spanish as the dominant family language in the home
- Severe motor and /or cognitive disability that would preclude evaluation of progress
- Limited electrode insertion likely to significantly impact development of speech perception
Show all 12Show fewer
- Hearing loss due to bacterial meningitis
- Dominant language other than English
- Diagnoses or medical conditions expected to impact language development independent of hearing loss
- Cochlear nerve deficiency in implanted ears or severe cochlear malformation
- Children already having spoken language who score better than 25th percentile on the Words and Sentences portion of the CDI language evaluation.
- Child with more than two months CI experience prior to start of treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Emily (Shimeng) Xu, PhD contact
United States1 site, 1 recruiting
- Recruiting
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Nancy Young, MD, nyoung@luriechildrens.org
About this study
Official title: Neural Prediction to Enhance Language Outcomes in Children With Cochlear Implant
The language outcome of children receiving cochlear implantation to address bilateral sensorineural hearing loss is more variable than that of typical hearing children. The research is focused upon development of neural predictive models based upon brain imaging to forecast language after cochlear implantation on the individual child level. The long-term goal is improving children's language by using predictive models to enable a custom "predict to prescribe" approach to intervene with more effective behavioral therapy for children at risk to develop poorer language. The investigators previously developed models for short term language outcome of English-learning implanted children. The aims of this study are to 1. Develop models able to predict long term outcome for English- learning and Spanish-learning children; and 2. To evaluate whether English-learning children predicted to achieve lower language based on the investigators' previously constructed models can demonstrate significant gains from Parent Implemented Communication Treatment (PICT). PICT is an intensive parent education program about strategies to improve children's communication.
Read the detailed description
Arm1: Non-treatment Model Building. Up to 700 children will be recruited from 5 cochlear implant programs in the United States. Children will be enrolled and followed for up to four years after implantation. Study information will be obtained from each child's medical record before and after implantation including cause of hearing loss, general health, language and communication history, family history, cochlear implant device and surgery. Audiological information before and after implantation will be collected from routine visits that are part of cochlear implant candidacy evaluation and audiology evaluations after implantation. This includes audiology evaluations after activation of the cochlear implant that take place at around 6, 12, 18, 24, 36 and/or 48 months. Pre-surgical MRI done at each participating site as part of routine pre-operative evaluation will also be collected for analysis. If enrolled into the study at Lurie Children's Hospital of Chicago before the pre-surgical MRI is done, the parent or guardian will have the option to have their child undergo additional research scans during the pre-surgical MRI.
Parents will be asked to complete baseline and follow-up surveys. The surveys will ask about family demographic and health information, language exposure in the home, therapy and school services, and language and communication ability of the child. Parental surveys will be readministered at about 12-month intervals after the child's device is turned on. In addition, surveys about the child's cognition will be sent to parents after their child has used their implant for one and two years. Surveys will be offered online by a secure link provided during clinical visits, emailed after the visit or sent by MyChart to the parent/guardian for completion at home.
An in-person research-only speech and language evaluation will be done at about one-year intervals after initial implantation during each year the child is enrolled in the study. The evaluation will take less than two hours.
Arm 2: Experimental: Communication Treatment is terminated. Study#372634 (the human subjects study record) to be removed/terminated in ASSIST.
- Conditions
- Bilateral Sensorineural Hearing Loss, Speech and Language Development Delay Due to Hearing Loss, Social Communication
- Being tested
- Parent-Implemented Communication Treatment
- Keywords
- Hearing Loss, Children, Parent-mediated intervention, Language prediction
- Medical subject headings
- Speech, Communication, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent-Implemented Communication TreatmentBehavioural
The intervention will be taught by a qualified professional online and/or in-person for about 6 months. Parents will learn strategies to enhance their children's social communication and will receive coaching and feedback.
| Study group | Role | What they receive |
|---|---|---|
| Non-treatment Model Building | No intervention | Not described |
| Communication Treatment | Experimental | Terminated Receives: Behavioral: Parent-Implemented Communication Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preschool Language Scales, Fifth Edition (PLS-5)
A standardized measure of auditory comprehension and expressive communication in children. Standard scores are obtained which are then translated to percentiles, and age equivalents. Higher standard scores indicate better performance.
Measured: At 12 months after cochlear implant activation
Preschool Language Scales, Fifth Edition (PLS-5)
A standardized measure of auditory comprehension and expressive communication in children. Standard scores are obtained which are then translated to percentiles, and age equivalents. Higher standard scores indicate better performance.
Measured: At 24 months after cochlear implant activation
Preschool Language Scales, Fifth Edition (PLS-5)
A standardized measure of auditory comprehension and expressive communication in children. Standard scores are obtained which are then translated to percentiles, and age equivalents. Higher standard scores indicate better performance.
Measured: At 36 months after cochlear implant activation
Preschool Language Scales, Fifth Edition (PLS-5)
A standardized measure of auditory comprehension and expressive communication in children. Standard scores are obtained which are then translated to percentiles, and age equivalents. Higher standard scores indicate better performance.
Measured: At 48 months after cochlear implant activation
Expressive One-Word Picture Vocabulary Test, Fourth Edition (EOWPVT-4)
An individually administered, norm-referenced assessment of how well a person can name objects, actions, or concepts presented in full-color pictures. Raw scores are obtained which are then translated to standard scores, percentiles, and age equivalents. Both higher standard scores and raw scores indicate better performance.
Measured: At 12 months after cochlear implant activation
Expressive One-Word Picture Vocabulary Test, Fourth Edition (EOWPVT-4)
An individually administered, norm-referenced assessment of how well a person can name objects, actions, or concepts presented in full-color pictures. Raw scores are obtained which are then translated to standard scores, percentiles, and age equivalents. Both higher standard scores and raw scores indicate better performance.
Measured: At 24 months after cochlear implant activation
Expressive One-Word Picture Vocabulary Test, Fourth Edition (EOWPVT-4)
An individually administered, norm-referenced assessment of how well a person can name objects, actions, or concepts presented in full-color pictures. Raw scores are obtained which are then translated to standard scores, percentiles, and age equivalents. Both higher standard scores and raw scores indicate better performance.
Measured: At 36 months after cochlear implant activation
Expressive One-Word Picture Vocabulary Test, Fourth Edition (EOWPVT-4)
An individually administered, norm-referenced assessment of how well a person can name objects, actions, or concepts presented in full-color pictures. Raw scores are obtained which are then translated to standard scores, percentiles, and age equivalents. Both higher standard scores and raw scores indicate better performance.
Measured: At 48 months after cochlear implant activation
MacArthur-Bates Communicative Development Inventory (CDI)
A set of online parent report intruments that evaluate children's early speech and langauge development. Standard scores are based on percentiles for age and sex and range from 1 to 99th percentile. Higher standard scores indicate better performance.
Measured: At 12 months after cochlear implant activation
MacArthur-Bates Communicative Development Inventory (CDI)
A set of online parent report intruments that evaluate children's early speech and langauge development. Standard scores are based on percentiles for age and sex and range from 1 to 99th percentile. Higher standard scores indicate better performance.
Measured: At 24 months after cochlear implant activation
MacArthur-Bates Communicative Development Inventory (CDI)
A set of online parent report intruments that evaluate children's early speech and langauge development. Standard scores are based on percentiles for age and sex and range from 1 to 99th percentile. Higher standard scores indicate better performance.
Measured: At 36 months after cochlear implant activation
MacArthur-Bates Communicative Development Inventory (CDI)
A set of online parent report intruments that evaluate children's early speech and langauge development. Standard scores are based on percentiles for age and sex and range from 1 to 99th percentile. Higher standard scores indicate better performance.
Measured: At 48 months after cochlear implant activation
Secondary outcomes (10)
Behavior Rating Inventory of Executive Function (BRIEF)
A parent-reported executive function questionnaire that utilizes T-scores to reflect individual's level of executive functioning. Higher T-scores indicate better performance.
Measured: At 12 months after cochlear implant activation
Behavior Rating Inventory of Executive Function (BRIEF)
A parent-reported executive function questionnaire that utilizes T-scores to reflect individual's level of executive functioning. Higher T-scores indicate better performance.
Measured: At 24 months after cochlear implant activation
Behavior Rating Inventory of Executive Function - Preschool Version (BRIEF-P)
A parent-reported executive function questionnaire designed for preschool-aged children that utilizes T-scores to reflect children's level of executive functioning. Higher T-scores indicate better performance.
Measured: At 12 months after cochlear implant activation
Behavior Rating Inventory of Executive Function - Preschool Version (BRIEF-P)
A parent-reported executive function questionnaire designed for preschool-aged children that utilizes T-scores to reflect children's level of executive functioning. Higher T-scores indicate better performance.
Measured: At 24 months after cochlear implant activation
Pediatric Minimum Speech Test Battery (PMSTB)
A set of measures designed to evaluate speech discrimination for infants and word/ sentence recognition for children using hearing technology before entering school. Scores range from 0 to 700. Higher scores indicate better performance.
Measured: At 6 months after cochlear implant activation
Pediatric Minimum Speech Test Battery (PMSTB)
A set of measures designed to evaluate speech discrimination for infants and word/ sentence recognition for children using hearing technology before entering school. Scores range from 0 to 700. Higher scores indicate better performance.
Measured: At 12 months after cochlear implant activation
Pediatric Minimum Speech Test Battery (PMSTB)
A set of measures designed to evaluate speech discrimination for infants and word/ sentence recognition for children using hearing technology before entering school. Scores range from 0 to 700. Higher scores indicate better performance.
Measured: At 18 months after cochlear implant activation
Pediatric Minimum Speech Test Battery (PMSTB)
A set of measures designed to evaluate speech discrimination for infants and word/ sentence recognition for children using hearing technology before entering school. Scores range from 0 to 700. Higher scores indicate better performance.
Measured: At 24 months after cochlear implant activation
Pediatric Minimum Speech Test Battery (PMSTB)
A set of measures designed to evaluate speech discrimination for infants and word/ sentence recognition for children using hearing technology before entering school. Scores range from 0 to 700. Higher scores indicate better performance.
Measured: At 36 months after cochlear implant activation
Pediatric Minimum Speech Test Battery (PMSTB)
A set of measures designed to evaluate speech discrimination for infants and word/ sentence recognition for children using hearing technology before entering school. Scores range from 0 to 700. Higher scores indicate better performance.
Measured: At 48 months after cochlear implant activation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start23 Jan 2023
- Primary completion23 Jul 2027 (estimated)
- Study completion23 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bilateral Sensorineural Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese University of Hong Kong, Northwestern University, University of North Carolina, Chapel Hill, University of Southern California, University of Miami, The University of Texas at Dallas
- Responsible party
- Principal investigator, Nancy Young, MD, Ann & Robert H Lurie Children's Hospital of Chicago
- Investigators
- Nancy M Young, MD, Principal investigator, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05962359
- Sponsor's protocol ID
- R01DC019387
- Status last verified
- Jun 2026
- First submitted
- 6 Jul 2023
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Prediction to Enhance Language Outcomes in Children With Cochlear Implant
- ClinicalTrials.gov ID
- NCT05962359
- Acronym / sponsor ID
- R01DC019387
- Conditions
- Bilateral Sensorineural Hearing Loss, Speech and Language Development Delay Due to Hearing Loss, Social Communication
- Keywords
- Hearing Loss, Children, Parent-mediated intervention, Language prediction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Collaborators
- Chinese University of Hong Kong, Northwestern University, University of North Carolina, Chapel Hill, University of Southern California, University of Miami, The University of Texas at Dallas
- Study start
- 23 Jan 2023 (actual)
- Primary completion
- 23 Jul 2027 (estimated)
- Study completion
- 23 Jan 2028 (estimated)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The language outcome of children receiving cochlear implantation to address bilateral sensorineural hearing loss is more variable than that of typical hearing children. The research is focused upon development of neural predictive models based upon brain imaging to forecast language after cochlear implantation on the individual child level. The long-term goal is improving children's language by using predictive models to enable a custom "predict to prescribe" approach to intervene with more effective behavioral therapy for children at risk to develop poorer language. The investigators previously developed models for short term language outcome of English-learning implanted children. The aims of this study are to 1. Develop models able to predict long term outcome for English- learning and Spanish-learning children; and 2. To evaluate whether English-learning children predicted to achieve lower language based on the investigators' previously constructed models can demonstrate significant gains from Parent Implemented Communication Treatment (PICT). PICT is an intensive parent education program about strategies to improve children's communication.
Detailed description
Arm1: Non-treatment Model Building. Up to 700 children will be recruited from 5 cochlear implant programs in the United States. Children will be enrolled and followed for up to four years after implantation. Study information will be obtained from each child's medical record before and after implantation including cause of hearing loss, general health, language and communication history, family history, cochlear implant device and surgery. Audiological information before and after implantation will be collected from routine visits that are part of cochlear implant candidacy evaluation and audiology evaluations after implantation. This includes audiology evaluations after activation of the cochlear implant that take place at around 6, 12, 18, 24, 36 and/or 48 months. Pre-surgical MRI done at each participating site as part of routine pre-operative evaluation will also be collected for analysis. If enrolled into the study at Lurie Children's Hospital of Chicago before the pre-surgical MRI is done, the parent or guardian will have the option to have their child undergo additional research scans during the pre-surgical MRI.
Parents will be asked to complete baseline and follow-up surveys. The surveys will ask about family demographic and health information, language exposure in the home, therapy and school services, and language and communication ability of the child. Parental surveys will be readministered at about 12-month intervals after the child's device is turned on. In addition, surveys about the child's cognition will be sent to parents after their child has used their implant for one and two years. Surveys will be offered online by a secure link provided during clinical visits, emailed after the visit or sent by MyChart to the parent/guardian for completion at home.
An in-person research-only speech and language evaluation will be done at about one-year intervals after initial implantation during each year the child is enrolled in the study. The evaluation will take less than two hours.
Arm 2: Experimental: Communication Treatment is terminated. Study#372634 (the human subjects study record) to be removed/terminated in ASSIST.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-treatment Model Building | No intervention | – |
| Communication Treatment | Experimental | Behavioral: Parent-Implemented Communication TreatmentTerminated |
Who may qualify
- Ages
- 0 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Children with sensorineural hearing loss who meet clinical criteria for cochlear implantation in both ears who meet the following age criteria at time cochlear implant evaluation begins:
- English or Spanish dominant language in the home.
- Children with bilateral sensorineural hearing loss who meet clinical criterial for cochlear implantation
- English dominant spoken language by family
- Age at implantation of 36 months and younger when treatment begins
Key exclusion criteria (12 listed)
- Severe motor and /or cognitive disability that would preclude evaluation of progress
- Limited electrode insertion likely to significantly impact development of speech perception
- Hearing loss due to bacterial meningitis
- Neither English or Spanish as the dominant family language in the home
- Severe motor and /or cognitive disability that would preclude evaluation of progress
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parent-Implemented Communication TreatmentThe intervention will be taught by a qualified professional online and/or in-person for about 6 months. Parents will learn strategies to enhance their children's social communication and will receive coaching and feedback. | Behavioural | Communication Treatment |
Primary outcome
Preschool Language Scales, Fifth Edition (PLS-5)
Time frame: At 12 months after cochlear implant activation
A standardized measure of auditory comprehension and expressive communication in children. Standard scores are obtained which are then translated to percentiles, and age equivalents. Higher standard scores indicate better performance.
Preschool Language Scales, Fifth Edition (PLS-5)
Time frame: At 24 months after cochlear implant activation
A standardized measure of auditory comprehension and expressive communication in children. Standard scores are obtained which are then translated to percentiles, and age equivalents. Higher standard scores indicate better performance.
Preschool Language Scales, Fifth Edition (PLS-5)
Time frame: At 36 months after cochlear implant activation
A standardized measure of auditory comprehension and expressive communication in children. Standard scores are obtained which are then translated to percentiles, and age equivalents. Higher standard scores indicate better performance.
Preschool Language Scales, Fifth Edition (PLS-5)
Time frame: At 48 months after cochlear implant activation
A standardized measure of auditory comprehension and expressive communication in children. Standard scores are obtained which are then translated to percentiles, and age equivalents. Higher standard scores indicate better performance.
Expressive One-Word Picture Vocabulary Test, Fourth Edition (EOWPVT-4)
Time frame: At 12 months after cochlear implant activation
An individually administered, norm-referenced assessment of how well a person can name objects, actions, or concepts presented in full-color pictures. Raw scores are obtained which are then translated to standard scores, percentiles, and age equivalents. Both higher standard scores and raw scores indicate better performance.
Expressive One-Word Picture Vocabulary Test, Fourth Edition (EOWPVT-4)
Time frame: At 24 months after cochlear implant activation
An individually administered, norm-referenced assessment of how well a person can name objects, actions, or concepts presented in full-color pictures. Raw scores are obtained which are then translated to standard scores, percentiles, and age equivalents. Both higher standard scores and raw scores indicate better performance.
Expressive One-Word Picture Vocabulary Test, Fourth Edition (EOWPVT-4)
Time frame: At 36 months after cochlear implant activation
An individually administered, norm-referenced assessment of how well a person can name objects, actions, or concepts presented in full-color pictures. Raw scores are obtained which are then translated to standard scores, percentiles, and age equivalents. Both higher standard scores and raw scores indicate better performance.
Expressive One-Word Picture Vocabulary Test, Fourth Edition (EOWPVT-4)
Time frame: At 48 months after cochlear implant activation
An individually administered, norm-referenced assessment of how well a person can name objects, actions, or concepts presented in full-color pictures. Raw scores are obtained which are then translated to standard scores, percentiles, and age equivalents. Both higher standard scores and raw scores indicate better performance.
MacArthur-Bates Communicative Development Inventory (CDI)
Time frame: At 12 months after cochlear implant activation
A set of online parent report intruments that evaluate children's early speech and langauge development. Standard scores are based on percentiles for age and sex and range from 1 to 99th percentile. Higher standard scores indicate better performance.
MacArthur-Bates Communicative Development Inventory (CDI)
Time frame: At 24 months after cochlear implant activation
A set of online parent report intruments that evaluate children's early speech and langauge development. Standard scores are based on percentiles for age and sex and range from 1 to 99th percentile. Higher standard scores indicate better performance.
MacArthur-Bates Communicative Development Inventory (CDI)
Time frame: At 36 months after cochlear implant activation
A set of online parent report intruments that evaluate children's early speech and langauge development. Standard scores are based on percentiles for age and sex and range from 1 to 99th percentile. Higher standard scores indicate better performance.
MacArthur-Bates Communicative Development Inventory (CDI)
Time frame: At 48 months after cochlear implant activation
A set of online parent report intruments that evaluate children's early speech and langauge development. Standard scores are based on percentiles for age and sex and range from 1 to 99th percentile. Higher standard scores indicate better performance.
10 secondary outcomes
Behavior Rating Inventory of Executive Function (BRIEF)
Time frame: At 12 months after cochlear implant activation
Behavior Rating Inventory of Executive Function (BRIEF)
Time frame: At 24 months after cochlear implant activation
Behavior Rating Inventory of Executive Function - Preschool Version (BRIEF-P)
Time frame: At 12 months after cochlear implant activation
Behavior Rating Inventory of Executive Function - Preschool Version (BRIEF-P)
Time frame: At 24 months after cochlear implant activation
Pediatric Minimum Speech Test Battery (PMSTB)
Time frame: At 6 months after cochlear implant activation
Pediatric Minimum Speech Test Battery (PMSTB)
Time frame: At 12 months after cochlear implant activation
Pediatric Minimum Speech Test Battery (PMSTB)
Time frame: At 18 months after cochlear implant activation
Pediatric Minimum Speech Test Battery (PMSTB)
Time frame: At 24 months after cochlear implant activation
Pediatric Minimum Speech Test Battery (PMSTB)
Time frame: At 36 months after cochlear implant activation
Pediatric Minimum Speech Test Battery (PMSTB)
Time frame: At 48 months after cochlear implant activation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emily (Shimeng) Xu, PhD contact
Nancy M Young, MD principal investigator
Ann & Robert H Lurie Children's Hospital of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent-Implemented Communication Treatment in people with Bilateral Sensorineural Hearing Loss and Speech and Language Development Delay Due to Hearing Loss, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nancy M Young, MD (312-227-6812, nyoung@luriechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preschool Language Scales, Fifth Edition (PLS-5) (time frame: At 12 months after cochlear implant activation). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.