Hearing LossHBD-CohortNCT07625462
Hearing and Brain Development Cohort in Children and Adolescents
An observational study of Hearing Loss, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
Trial summary
This bidirectional observational cohort study aims to establish a Hearing and Brain Development (HBD) cohort in children and adolescents with hearing loss across different hearing management pathways, including hearing aid fitting, cochlear implantation, auditory brainstem implantation, gene therapy, and follow-up… Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2026to 31 Dec 2030
- Phase
- Observational
- 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 Up to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: The study population consists of children and adolescents aged 0 to 18 years who are evaluated and/or managed at the Department of Otolaryngology-Head and Neck Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine. The cohort includes participants with hearing loss across different hearing management pathways, including hearing aid fitting, cochlear implantation, auditory brainstem implantation, gene therapy, and follow-up without intervention, as well as a normal-hearing control group.
Who may be able to join
- Age no more than 18 years.
- For the HA/CI/ABI/GT/FU groups: behavioral or pure-tone hearing threshold >=20 dB HL, or air-conduction ABR >=35 dB nHL; For the normal-hearing control group: participants diagnosed as normal hearing by experienced physicians.
Who cannot join
- Inability to cooperate with study testing procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, 200011
Yun Li, +86-21-53314064, liyuncmm@126.com
About this study
Official title: A Longitudinal Cohort Study of Hearing and Brain Development in Children and Adolescents With Hearing Loss Across Different Hearing Management Pathways and in Normal-Hearing Controls
This bidirectional observational cohort study aims to establish a Hearing and Brain Development (HBD) cohort in children and adolescents with hearing loss across different hearing management pathways, including hearing aid fitting, cochlear implantation, auditory brainstem implantation, gene therapy, and follow-up without intervention, as well as in a normal-hearing control group. Participants will undergo longitudinal assessments of hearing, speech, language, neurodevelopment, and multimodal brain function.
- Conditions
- Hearing Loss
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HA | Participants suitable for unilateral or bilateral hearing aid(s) fitting, without any other intervention methods (cochlear implantation, gene therapy treatment, auditory brainstem implantation, etc.). | |
| CI | Participants suitable for unilateral or bilateral cochlear implantation, without gene therapy treatment or auditory brainstem implantation. | |
| ABI | Participants suitable for unilateral or bilateral auditory brainstem implantation. | |
| GT | Participants suitable for gene therapy treatment. | |
| FU | Participants with hearing loss who do not receive any intervention. | |
| NH Control | Participants with normal hearing who are enrolled as healthy controls. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Categories of Auditory Performance-II Score
The Categories of Auditory Performance-II scale will be used to assess auditory performance. Scores range from 0 to 9, with higher scores indicating better auditory performance. Change is calculated as the value at follow-up minus the baseline value.
Measured: From baseline to 24-month follow-up
Change in Speech Intelligibility Rating Score
The Speech Intelligibility Rating scale will be used to assess speech intelligibility. Scores range from 1 to 5, with higher scores indicating better speech intelligibility. Change is calculated as the value at follow-up minus the baseline value.
Measured: From baseline to 24-month follow-up
Change in MRI-derived Brain Development Deviation Composite Score
The MRI-derived Brain Development Deviation Composite Score will be calculated from pre-specified multimodal brain magnetic resonance imaging measures using age-adjusted normative models. All pre-specified MRI measures will be combined into a single standardized composite score before analysis. The score summarizes the magnitude of deviation from age-expected brain development. Higher values indicate greater deviation from age-expected brain development. Change is calculated as the value at follow-up minus the baseline value.
Measured: From baseline to 24-month follow-up
Secondary outcomes (4)
Change in Parent-Child Interaction Quality Composite Score
The Parent-Child Interaction Quality Composite Score will be used to assess parent-child interaction quality based on a pre-specified observational coding scheme. The composite score summarizes overall interaction quality during recorded parent-child interaction tasks. Higher scores indicate better parent-child interaction quality. Change is calculated as the value at follow-up minus the baseline value.
Measured: From baseline to 24-month follow-up
Change in Griffiths Mental Development Scales General Development Score
The Griffiths Mental Development Scales will be used to assess general developmental level. The general development score reflects overall developmental functioning across multiple developmental domains. Higher scores indicate better general developmental functioning. Change is calculated as the value at follow-up minus the baseline value.
Measured: From baseline to 24-month follow-up
Change in Ages and Stages Questionnaires: Social-Emotional, Second Edition Total Score
The Ages and Stages Questionnaires: Social-Emotional, Second Edition will be used to assess social-emotional development. Total scores vary by age-specific form, with higher scores indicating greater social-emotional concern. Change is calculated as the value at follow-up minus the baseline value.
Measured: From baseline to 24-month follow-up
Change in Adaptive Behavior Assessment System, Second Edition General Adaptive Composite Score
The Adaptive Behavior Assessment System, Second Edition will be used to assess adaptive behavior. The General Adaptive Composite score summarizes overall adaptive functioning across daily living, communication, social, and practical adaptive skill areas. Higher scores indicate better adaptive functioning. Change is calculated as the value at follow-up minus the baseline value.
Measured: From baseline to 24-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start20 May 2026 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hao Wu, Principal investigator, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of MedicineHao Wu, Study chair, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07625462
- Sponsor's protocol ID
- HBD-Cohort
- Acronym
- HBD-Cohort
- Status last verified
- Apr 2026
- First submitted
- 20 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal Cohort Study of Hearing and Brain Development in Children and Adolescents With Hearing Loss Across Different Hearing Management Pathways and in Normal-Hearing Controls
- ClinicalTrials.gov ID
- NCT07625462
- Acronym / sponsor ID
- HBD-Cohort / HBD-Cohort
- Conditions
- Hearing Loss
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 20 May 2026 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 4 Jun 2026 (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.
This bidirectional observational cohort study aims to establish a Hearing and Brain Development (HBD) cohort in children and adolescents with hearing loss across different hearing management pathways, including hearing aid fitting, cochlear implantation, auditory brainstem implantation, gene therapy, and follow-up without intervention, as well as in a normal-hearing control group. Participants will undergo longitudinal assessments of hearing, speech, language, neurodevelopment, and multimodal brain function.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| HA | – | –Participants suitable for unilateral or bilateral hearing aid(s) fitting, without any other intervention methods (cochlear implantation, gene therapy treatment, auditory brainstem implantation, etc.). |
| CI | – | –Participants suitable for unilateral or bilateral cochlear implantation, without gene therapy treatment or auditory brainstem implantation. |
| ABI | – | –Participants suitable for unilateral or bilateral auditory brainstem implantation. |
| GT | – | –Participants suitable for gene therapy treatment. |
| FU | – | –Participants with hearing loss who do not receive any intervention. |
| NH Control | – | –Participants with normal hearing who are enrolled as healthy controls. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The study population consists of children and adolescents aged 0 to 18 years who are evaluated and/or managed at the Department of Otolaryngology-Head and Neck Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine. The cohort includes participants with hearing loss across different hearing management pathways, including hearing aid fitting, cochlear implantation, auditory brainstem implantation, gene therapy, and follow-up without intervention, as well as a normal-hearing control group.
Key inclusion criteria (2 listed)
- Age no more than 18 years.
- For the HA/CI/ABI/GT/FU groups: behavioral or pure-tone hearing threshold >=20 dB HL, or air-conduction ABR >=35 dB nHL; For the normal-hearing control group: participants diagnosed as normal hearing by experienced physicians.
Key exclusion criteria (1 listed)
- Inability to cooperate with study testing procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Categories of Auditory Performance-II Score
Time frame: From baseline to 24-month follow-up
The Categories of Auditory Performance-II scale will be used to assess auditory performance. Scores range from 0 to 9, with higher scores indicating better auditory performance. Change is calculated as the value at follow-up minus the baseline value.
Change in Speech Intelligibility Rating Score
Time frame: From baseline to 24-month follow-up
The Speech Intelligibility Rating scale will be used to assess speech intelligibility. Scores range from 1 to 5, with higher scores indicating better speech intelligibility. Change is calculated as the value at follow-up minus the baseline value.
Change in MRI-derived Brain Development Deviation Composite Score
Time frame: From baseline to 24-month follow-up
The MRI-derived Brain Development Deviation Composite Score will be calculated from pre-specified multimodal brain magnetic resonance imaging measures using age-adjusted normative models. All pre-specified MRI measures will be combined into a single standardized composite score before analysis. The score summarizes the magnitude of deviation from age-expected brain development. Higher values indicate greater deviation from age-expected brain development. Change is calculated as the value at follow-up minus the baseline value.
4 secondary outcomes
Change in Parent-Child Interaction Quality Composite Score
Time frame: From baseline to 24-month follow-up
Change in Griffiths Mental Development Scales General Development Score
Time frame: From baseline to 24-month follow-up
Change in Ages and Stages Questionnaires: Social-Emotional, Second Edition Total Score
Time frame: From baseline to 24-month follow-up
Change in Adaptive Behavior Assessment System, Second Edition General Adaptive Composite Score
Time frame: From baseline to 24-month follow-up
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 4 Jun 2026.
- Individual participant dataSharing planned: Yes
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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.
Hao Wu principal investigator
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Hao Wu study chair
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Loss, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
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 2 inclusion and 1 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 4 Jun 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 China. 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 Yun Li (+86-21-53314064, liyuncmm@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Categories of Auditory Performance-II Score (time frame: From baseline to 24-month follow-up). The study lists 3 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 4 Jun 2026.