Hearing LossCIRCLENCT07380269
Cochlear Implant Recipients: Comprehensive Longitudinal Evaluation
An observational study of Hearing Loss and Hearing Loss, Sensorineural, run by Eye & ENT Hospital of Fudan University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hearing Loss, Hearing Loss, Sensorineural, Deafness
- What is being tested?
- Cochlear Implantation
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 22 Aug 2025to Sep 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study 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.
Who may be able to join
- 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.
- Ability to communicate effectively with the researcher with the help of a guardian and comply with the researcher's requirements. For young children without mature language skills, ability to cooperate with the help of a guardian.
- The subject's guardian has a correct understanding of the trial and realistic expectations of potential benefits.
Who cannot join
- 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.
- Any other condition considered by the investigator to make 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: Comprehensive Follow-up and Evaluation for Cochlear Implant Patients for All Ages
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.
Read the detailed description
The study aims to conduct a comprehensive evaluation of auditory and speech perception abilities, as well as overall quality of life, in patients with hearing loss across all age groups undergoing cochlear implantation. By comparing pre- and post-operative outcomes, the study will investigate how different age cohorts and subtype groups respond to cochlear implantation treatment. The findings are expected to provide critical evidence to guide the development of individualized auditory and speech rehabilitation strategies.
- Conditions
- Hearing Loss, Hearing Loss, Sensorineural, Deafness, Cochlear Implantation, Speech Perception
- Being tested
- Cochlear Implantation
- Keywords
- Cochlear Implant, Pediatric Cochlear Implantation, Adult Cochlear Implantation, Auditory Rehabilitation, Speech Recognition, Quality of Life, Cognitive Function, Observational Cohort
- Medical subject headings
- Hearing Loss, Hearing Loss, Sensorineural, Deafness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cochlear ImplantationProcedure or surgery
cochlear 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.
| Study group | Role | What they receive |
|---|---|---|
| Cochlear Implant Recipients | Not described Receives: Procedure: Cochlear Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (2)
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.
Measured: 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.
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).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start22 Aug 2025
- Primary completionSep 2030 (estimated)
- Study completionSep 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.
- 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07380269
- Sponsor's protocol ID
- 2025192
- Acronym
- CIRCLE
- Status last verified
- Sep 2025
- First submitted
- 10 Jan 2026
- Last updated
- 2 Feb 2026
- 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 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Follow-up and Evaluation for Cochlear Implant Patients for All Ages
- ClinicalTrials.gov ID
- NCT07380269
- Acronym / sponsor ID
- CIRCLE / 2025192
- Conditions
- Hearing Loss, Hearing Loss, Sensorineural, Deafness, Cochlear Implantation, Speech Perception
- Keywords
- Cochlear Implant, Pediatric Cochlear Implantation, Adult Cochlear Implantation, Auditory Rehabilitation, Speech Recognition, Quality of Life, Cognitive Function, Observational Cohort
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 22 Aug 2025 (actual)
- Primary completion
- Sep 2030 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 2 Feb 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 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.
Detailed description
The study aims to conduct a comprehensive evaluation of auditory and speech perception abilities, as well as overall quality of life, in patients with hearing loss across all age groups undergoing cochlear implantation. By comparing pre- and post-operative outcomes, the study will investigate how different age cohorts and subtype groups respond to cochlear implantation treatment. The findings are expected to provide critical evidence to guide the development of individualized auditory and speech rehabilitation strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cochlear Implant Recipients | – | Procedure: Cochlear Implantation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study 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.
Key inclusion criteria (6 listed)
- 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.
- Ability to communicate effectively with the researcher with the help of a guardian and comply with the researcher's requirements. For young children without mature language skills, ability to cooperate with the help of a guardian.
Key exclusion criteria (5 listed)
- 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.
- Any other condition considered by the investigator to make 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 |
|---|---|---|
| Cochlear Implantationcochlear 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. | Procedure or surgery | Cochlear Implant Recipients |
Primary outcome
Evaluation of Auditory Function
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.
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.
2 secondary outcomes
Evaluation of Speech Function
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.
Assessment of Psychosocial and Functional Outcomes
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.
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 2 Feb 2026.
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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?
An observational study of Hearing Loss and Hearing Loss, Sensorineural, 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 6 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 2 Feb 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 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?
Evaluation of Auditory Function (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.). 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 2 Feb 2026; AzTrials last refreshed its copy on 28 Oct 2026.