Cochlear Implant Recipients: Comprehensive Longitudinal Evaluation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorEye & ENT Hospital of Fudan University
About this trial
This study aims to assess hearing and speech perception, as well as quality of life, in deaf patients of all ages before and after cochlear implantation, and to explore differences across age groups and treatment subtypes, thereby providing evidence for personalized hearing and speech rehabilitation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with severe or greater hearing loss (≥65 dB) scheduled to receive cochlear implant (CI) treatment.
No restrictions on age or gender.
Native language is Mandarin Chinese.
The subject and/or their legal guardian must provide informed consent prior to the study, voluntarily sign a written informed consent form, and be willing to undergo follow-up assessments at the specified time points.
Disqualifiers
Presence of other severe diseases unsuitable for cochlear implantation surgery.
Significant psychological problems or mood disorders (e.g., notable anxiety, depression, or behavioral disorders) that would preclude cooperation with training and follow-up.
Neurological diseases (e.g., epilepsy, cerebral palsy) that may affect auditory processing ability.
Concurrent participation in other interventional studies involving drugs or behavioral interventions that may affect auditory rehabilitation during the study period.
Trial population
A single-center, observational cohort of patients across all age groups (children and adults) with severe-to-profound hearing loss who are candidates for and receive cochlear implantation.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Cochlear Implantation
Procedure/Surgerycochlear implantation - a surgical procedure designed to provide auditory perception to individuals with severe-to-profound sensorineural hearing loss who receive limited to no benefits from conventional amplification.
Treatment groups
300 Participants
are divided into 1 treatment groupGroup A: Cochlear Implant Recipients1 intervention
Trial outcomes
Primary outcomes
1
Evaluation of Auditory Function
A comprehensive assessment of auditory sensitivity and daily listening abilities. Objective measures include electrophysiological tests (Auditory Brainstem Response, ABR; Auditory Steady-State Response, ASSR) for threshold estimation, particularly in non-communicative subjects. Behavioral audiometry and sound-field testing determine hearing thresholds in dB HL. Distortion Product Otoacoustic Emissions (DPOAE) assess cochlear outer hair cell function. Subjective auditory performance is evaluated using standardized questionnaires: the Categories of Auditory Performance (CAP, range 0-7, higher is better).The Parents' Evaluation of Aural/oral performance of Children (PEACH), consists of 12 core items, each rated on a 5-point scale from 0 to 4. Total scores are calculated to a percentage, ranging from 0% to 100%. A higher percent indicates better auditory and communication performance.
Time frame
From enrollment until the end of the 5-year follow-up. Assessments are conducted preoperatively, at device activation, and post-activation at 4 weeks, 13 weeks, 26 weeks, 52 weeks, 2 years, 3 years, and 5 years.Secondary outcomes
1
Evaluation of Speech Function
Assessment of speech perception and production abilities.Objective measure of speech perception ability. The outcome is the percentage of correct responses (%) on standardized speech recognition tests, such as monosyllabic word and sentence recognition tests, administered in quiet and in noise. The score ranges from 0% to 100%. A higher percentage indicates better speech perception.Speech production ability is evaluated using the Speech Intelligibility Rating (SIR), an observer-rated scale from 1 (unintelligible) to 5 (spontaneous speech is fully intelligible).A higher rating indicates more intelligible speech.
Time frame
From enrollment until the end of the 5-year follow-up. Assessments are conducted preoperatively, at device activation, and post-activation at 4 weeks, 13 weeks, 26 weeks, 52 weeks, 2 years, 3 years, and 5 years.2
Assessment of Psychosocial and Functional Outcomes
Multidimensional evaluation of the impact of cochlear implantation on cognitive status, spatial hearing, quality of life, and related symptoms. Tools include:the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE; average score, 1-5, higher=greater decline) for cognition; the Speech, Spatial and Qualities of Hearing Scale-Short Form (SSQ-12; mean item score, 0-10, higher=better) for spatial hearing; the Cochlear Implant Quality of Life (CIQoL; global score, higher=better QoL) instrument; the Vanderbilt Fatigue Scale (total score, higher=greater fatigue); and the Tinnitus Handicap Inventory (THI; total score, 0-100, higher=greater handicap).
Time frame
From enrollment until the end of the 5-year follow-up. Assessments are conducted preoperatively, at device activation, and post-activation at 4 weeks, 13 weeks, 26 weeks, 52 weeks, 2 years, 3 years, and 5 years.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov