Congenital Hearing LossNCT07024524
Perceptual Evaluation and Rehabilitation System Development for Congenital Hearing Loss
A study testing Rehabilitation training in people with Congenital Hearing Loss and Gene Therapy, run by Eye & ENT Hospital of Fudan University at 1 site in China.
Trial summary
This study aims to establish a novel multimodal evaluation and precision rehabilitation system for patients with congenital hearing loss who have received hearing aids, cochlear implantation, or emerging gene therapy. Read more about this study
- Who is it for?
- Ages 1 year to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Congenital Hearing Loss, Gene Therapy, Speech Perception
- What is being tested?
- Rehabilitation training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteChina
- Study dates
- 4 Jul 2025to 5 May 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 1 year to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- For Congenital Deafness Group: Patients with congenital hearing loss with hearing thresholds ≥65 dB who have received hearing aids, cochlear implantation, or gene therapy; Age between 1 and 35 years old, regardless of gender.
- For Healthy Controls Group: Participants with normal hearing thresholds (≤20 dB) whose age and gender matched to the patient group.
- Mandarin Chinese as the native language. Participants and/or their guardians must provide informed consent before the trial, voluntarily sign a written consent form, and commit to receive evaluation at specified time points.
- Capable of effective communication with researchers under the guardian's assistance and willing to cooperate and comply with the researchers' requirements.
- Participants and/or their guardians should have a correct understanding of the trial and appropriate expectations regarding potential benefits.
Who cannot join
- Presence of other otological disorders that may interfere with the surgical outcome or interpretation of study endpoints, such as otitis media, Meniere's disease, etc.
- Presence of other severe congenital diseases, such as congenital heart disease. Presence of severe systemic diseases or in the acute onset of diseases, such as pulmonary tuberculosis, active hepatitis B or C infection, active herpes zoster infection, pancreatitis, renal insufficiency, etc.
- Individuals with low immunity, a history of immune deficiency or organ transplantation.
- Individuals with a history of neurological, mental disorders, or moderate-to-severe cognitive dysfunction, such as epilepsy, dementia, autism spectrum disorders, etc.
- Any other conditions for which the investigators consider the subject unsuitable for participation in this clinical study.
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
Eye & ENT Hospital of Fudan University
Shanghai, 200031
Yilai Shu, M.D.& Ph.D., +86 21 6437 7134, yilai_shu@fudan.edu.cn
About this study
Official title: Development and Application of A Multimodal Perceptual Evaluation and Precision Rehabilitation System in Congenital Deafness
This study aims to establish a novel multimodal evaluation and precision rehabilitation system for patients with congenital hearing loss who have received hearing aids, cochlear implantation, or emerging gene therapy. The proposed system will integrate age-stratified difficulty levels, combined with a gamified interaction platform or software designed to assess and train three core perceptual domains: auditory speech perception, music perception, and spatial hearing capabilities.
Read the detailed description
For congenital sensorineural hearing loss, the traditional treatment methods are hearing aids and cochlear implantation. In recent years, groundbreaking progress has been made in the field of gene therapy for deafness. However, existing assessment materials and tools are not fully applicable to gene therapy patients. In addition, most assessment materials also show other limitations, including a relatively single assessment dimension with minimal gamified interaction and a lack of age-stratified difficulty levels, etc., which pose challenges in objective and comprehensive evaluation, especially for younger children. There is an urgent need to redesign, optimize, and supplement current assessment tools to more accurately reflect post-treatment multidimensional perceptual function, establish a comprehensive evaluation system, and provide targeted rehabilitation guidance.
Therefore, this study aims to upgrade and develop a novel multimodal evaluation and precision rehabilitation system for patients with congenital hearing loss across different ages and various treatment types. Based on the existing assessment materials and software, the proposed system will combine the gamified method and interactive, friendly interface to construct a set of interesting and interactive measurements, integrating auditory speech, music perception, spatial hearing assessment and rehabilitation training. Patients with congenital hearing loss and healthy controls will be recruited to validate the reliability and validity of the evaluation system and the effectiveness of the rehabilitation training, providing reference for clinical application.
- Conditions
- Congenital Hearing Loss, Gene Therapy, Speech Perception, Rehabilitation, Reliability and Validity
- Being tested
- Rehabilitation training
- Keywords
- Congenital hearing loss, Gene therapy, Multimodal assessment, Auditory speech perception, Music perception, Spatial hearing, Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation trainingOther
This study constructed a novel multimodal assessment system to evaluate speech perception, music perception, and spatial hearing in congenital deafness patients , and subsequently generated targeted rehabilitation training plan based on the assessment data.
| Study group | Role | What they receive |
|---|---|---|
| Congenital Hearing Loss Group | Experimental | The study will recruit patients with congenital hearing loss with hearing thresholds ≥65 dB who have received hearing aids, cochlear implantation, or gene therapy. Receives: Other: Rehabilitation training |
| Healthy Controls Group | No intervention | The study will recruit participants with normal hearing thresholds (≤20 dB) whose age and gender were matched to the patient group.Stage 1 involved an observational study for reliability and validity assessment, enrolling both healthy subjects and congenital deafness patients . Stage 2 involved an interventional study for rehabilitation training, which included congenital deafness patients .Healthy Controls Group were only enrolled in the Stage 1 for reliability and validity assessment, but not the Stage 2 for rehabilitation training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reliability
The reliability of the evaluation system were assessed using Cronbach's α coefficient .
Measured: Baseline
Reliability
The test-retest reliability of the evaluation system were assessed using Pearson correlation coefficient.
Measured: Baseline and 1-4 weeks later.
Validity
The validity of the evaluation system were assessed using Exploratory Factor Analysis, EFA and/or Confirmatory Factor Analysis, CFA.
Measured: Baseline
Secondary outcomes (3)
Effectiveness of the Rehabilitation System
Changes in the test scores for speech perception from baseline.
Measured: Baseline and 1-3 months after rehabilitation training.
Effectiveness of the Rehabilitation System
Changes in the test scores for music perception from baseline.
Measured: Baseline and 1-3 months after rehabilitation training.
Effectiveness of the Rehabilitation System
Changes in the test scores for spatial hearing perception from baseline.
Measured: Baseline and 1-3 months after rehabilitation training.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start4 Jul 2025
- Primary completion1 Jan 2028 (estimated)
- Study completion5 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Hearing LossStudies of the same condition, open and under way.
- More trials run by Eye & ENT Hospital of Fudan 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Stage 1 involved an observational study for reliability and validity assessment, enrolling both healthy subjects and congenital deafness patients . Stage 2 involved an interventional study for rehabilitation training, which included congenital deafness patients .
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Rehabilitation Institute for the Exceptional Children
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07024524
- Sponsor's protocol ID
- 2025084-1
- Status last verified
- Jul 2025
- First submitted
- 20 May 2025
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Application of A Multimodal Perceptual Evaluation and Precision Rehabilitation System in Congenital Deafness
- ClinicalTrials.gov ID
- NCT07024524
- Acronym / sponsor ID
- 2025084-1
- Conditions
- Congenital Hearing Loss, Gene Therapy, Speech Perception, Rehabilitation, Reliability and Validity
- Keywords
- Congenital hearing loss, Gene therapy, Multimodal assessment, Auditory speech perception, Music perception, Spatial hearing, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Collaborators
- Shanghai Rehabilitation Institute for the Exceptional Children
- Study start
- 4 Jul 2025 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 5 May 2028 (estimated)
- First posted
- 17 Jun 2025 (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 study aims to establish a novel multimodal evaluation and precision rehabilitation system for patients with congenital hearing loss who have received hearing aids, cochlear implantation, or emerging gene therapy. The proposed system will integrate age-stratified difficulty levels, combined with a gamified interaction platform or software designed to assess and train three core perceptual domains: auditory speech perception, music perception, and spatial hearing capabilities.
Detailed description
For congenital sensorineural hearing loss, the traditional treatment methods are hearing aids and cochlear implantation. In recent years, groundbreaking progress has been made in the field of gene therapy for deafness. However, existing assessment materials and tools are not fully applicable to gene therapy patients. In addition, most assessment materials also show other limitations, including a relatively single assessment dimension with minimal gamified interaction and a lack of age-stratified difficulty levels, etc., which pose challenges in objective and comprehensive evaluation, especially for younger children. There is an urgent need to redesign, optimize, and supplement current assessment tools to more accurately reflect post-treatment multidimensional perceptual function, establish a comprehensive evaluation system, and provide targeted rehabilitation guidance.
Therefore, this study aims to upgrade and develop a novel multimodal evaluation and precision rehabilitation system for patients with congenital hearing loss across different ages and various treatment types. Based on the existing assessment materials and software, the proposed system will combine the gamified method and interactive, friendly interface to construct a set of interesting and interactive measurements, integrating auditory speech, music perception, spatial hearing assessment and rehabilitation training. Patients with congenital hearing loss and healthy controls will be recruited to validate the reliability and validity of the evaluation system and the effectiveness of the rehabilitation training, providing reference for clinical application.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stage 1 involved an observational study for reliability and validity assessment, enrolling both healthy subjects and congenital deafness patients . Stage 2 involved an interventional study for rehabilitation training, which included congenital deafness patients .
| Arm | Type | Receives |
|---|---|---|
| Congenital Hearing Loss Group | Experimental | Other: Rehabilitation trainingThe study will recruit patients with congenital hearing loss with hearing thresholds ≥65 dB who have received hearing aids, cochlear implantation, or gene therapy. |
| Healthy Controls Group | No intervention | –The study will recruit participants with normal hearing thresholds (≤20 dB) whose age and gender were matched to the patient group.Stage 1 involved an observational study for reliability and validity assessment, enrolling both healthy subjects and congenital deafness patients . Stage 2 involved an interventional study for rehabilitation training, which included congenital deafness patients .Healthy Controls Group were only enrolled in the Stage 1 for reliability and validity assessment, but not the Stage 2 for rehabilitation training. |
Who may qualify
- Ages
- 1 year to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- For Congenital Deafness Group: Patients with congenital hearing loss with hearing thresholds ≥65 dB who have received hearing aids, cochlear implantation, or gene therapy; Age between 1 and 35 years old, regardless of gender.
- For Healthy Controls Group: Participants with normal hearing thresholds (≤20 dB) whose age and gender matched to the patient group.
- Mandarin Chinese as the native language. Participants and/or their guardians must provide informed consent before the trial, voluntarily sign a written consent form, and commit to receive evaluation at specified time points.
- Capable of effective communication with researchers under the guardian's assistance and willing to cooperate and comply with the researchers' requirements.
- Participants and/or their guardians should have a correct understanding of the trial and appropriate expectations regarding potential benefits.
Key exclusion criteria (5 listed)
- Presence of other otological disorders that may interfere with the surgical outcome or interpretation of study endpoints, such as otitis media, Meniere's disease, etc.
- Presence of other severe congenital diseases, such as congenital heart disease. Presence of severe systemic diseases or in the acute onset of diseases, such as pulmonary tuberculosis, active hepatitis B or C infection, active herpes zoster infection, pancreatitis, renal insufficiency, etc.
- Individuals with low immunity, a history of immune deficiency or organ transplantation.
- Individuals with a history of neurological, mental disorders, or moderate-to-severe cognitive dysfunction, such as epilepsy, dementia, autism spectrum disorders, etc.
- Any other conditions for which the investigators consider the subject unsuitable for participation in this clinical study.
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 |
|---|---|---|
| Rehabilitation trainingThis study constructed a novel multimodal assessment system to evaluate speech perception, music perception, and spatial hearing in congenital deafness patients , and subsequently generated targeted rehabilitation training plan based on the assessment data. | Other | Congenital Hearing Loss Group |
Primary outcome
Reliability
Time frame: Baseline
The reliability of the evaluation system were assessed using Cronbach's α coefficient .
Reliability
Time frame: Baseline and 1-4 weeks later.
The test-retest reliability of the evaluation system were assessed using Pearson correlation coefficient.
Validity
Time frame: Baseline
The validity of the evaluation system were assessed using Exploratory Factor Analysis, EFA and/or Confirmatory Factor Analysis, CFA.
3 secondary outcomes
Effectiveness of the Rehabilitation System
Time frame: Baseline and 1-3 months after rehabilitation training.
Effectiveness of the Rehabilitation System
Time frame: Baseline and 1-3 months after rehabilitation training.
Effectiveness of the Rehabilitation System
Time frame: Baseline and 1-3 months after rehabilitation training.
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 28 Jul 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation training in people with Congenital Hearing Loss and Gene Therapy, run by Eye & ENT Hospital of Fudan 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 5 inclusion and 5 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 28 Jul 2025. 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 Yilai Shu, M.D.& Ph.D. (+86 21 6437 7134, yilai_shu@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reliability (time frame: Baseline). 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 28 Jul 2025.