Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | From baseline to 24-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yun Li | Contact | +86-21-53314064 | liyuncmm@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Hao Wu | Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| Hao Wu | Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | 200011 | China |
Not provided
The IPD will be available beginning 6 months after study completion.
Detailed data are available upon reasonable request.
Not provided
Not provided
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Blood
| 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. | 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. | 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. | From baseline to 24-month follow-up |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |