Perceptual Evaluation and Rehabilitation System Development for Congenital Hearing Loss

NCT07024524 | Recruiting DMC

• 1 other identifier: 2025084-1
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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

Outcome Measures

Primary Outcomes (3)

• Reliability

  The reliability of the evaluation system were assessed using Cronbach's α coefficient .

  Baseline

• Reliability

  The test-retest reliability of the evaluation system were assessed using Pearson correlation coefficient.

  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.

  Baseline

Secondary Outcomes (3)

• Effectiveness of the Rehabilitation System

  Baseline and 1-3 months after rehabilitation training.

• Effectiveness of the Rehabilitation System

  Baseline and 1-3 months after rehabilitation training.

• Effectiveness of the Rehabilitation System

  Baseline and 1-3 months after rehabilitation training.

Study Arms (2)

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.

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.

Interventions

Rehabilitation training OTHER

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.

Congenital Hearing Loss Group

Eligibility Criteria

• Age: 1 Year - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eye & ENT Hospital of Fudan University: lead
• Shanghai Rehabilitation Institute for the Exceptional Children: collaborator

Study Sites (1)

Eye & ENT Hospital of Fudan University

Shanghai, 200031, China

RECRUITING

Central Study Contacts

Yilai Shu, M.D.& Ph.D.

CONTACT

+86 21 6437 7134; yilai_shu@fudan.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 .

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: June 17, 2025
• Study Start: July 4, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): May 5, 2028
• Last Updated: July 28, 2025

Record last verified: 2025-07

Locations

CN (1)