Cochlear Function DisorderNCT06896864
Cochlear Implantation Experience
An observational study of Cochlear Function Disorder, run by Assiut University.
Trial summary
Evaluating the effectiveness and outcomes of cochlear implants in individuals with hearing loss,identifying common complications or risks associated with cochlear implantation, including device failure, surgical complications, or issues related to the patient's anatomy Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Cochlear Function Disorder
- What is being tested?
- cochlear implantation
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 8 Apr 2025to 30 May 2026
- How long will I take part?
- 2 Years
- 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All cases implanted between 2014-2024 Patients who regularly use their cochlear implant device as recommended.
Who may be able to join
- Patients with severe to profound bilateral sensorineural hearing loss who were candidates for CI.
- Patients who regularly use their cochlear implant device as recommended.
Who cannot join
- Non-Sensorineural Hearing Loss - Non-Functional Auditory Nerve - . Severe Mental or Cognitive Impairments
About this study
Official title: Cochlear Implantation in Assiut University Hospital Experience
Evaluating the effectiveness and outcomes of cochlear implants in individuals with hearing loss,identifying common complications or risks associated with cochlear implantation, including device failure, surgical complications, or issues related to the patient's anatomy
- Conditions
- Cochlear Function Disorder
- Being tested
- cochlear implantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cochlear implantationProcedure or surgery
After the surgery, patients typically undergo a period of recovery and healing. several factors including age at implantation, pre- and post-operative therapy, and parental involvement
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-Surgical Complication Rate: Infection, device failure,Measures auditory progression
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start8 Apr 2025 (estimated)
- Primary completion30 Mar 2026 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cochlear Function DisorderStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 150 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tasneem Sayed Hussein, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06896864
- Sponsor's protocol ID
- CI experience
- Status last verified
- Mar 2025
- First submitted
- 20 Mar 2025
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cochlear Implantation in Assiut University Hospital Experience
- ClinicalTrials.gov ID
- NCT06896864
- Acronym / sponsor ID
- CI experience
- Conditions
- Cochlear Function Disorder
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 8 Apr 2025 (estimated)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 26 Mar 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.
Evaluating the effectiveness and outcomes of cochlear implants in individuals with hearing loss,identifying common complications or risks associated with cochlear implantation, including device failure, surgical complications, or issues related to the patient's anatomy
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All cases implanted between 2014-2024 Patients who regularly use their cochlear implant device as recommended.
Key inclusion criteria (2 listed)
- Patients with severe to profound bilateral sensorineural hearing loss who were candidates for CI.
- Patients who regularly use their cochlear implant device as recommended.
Key exclusion criteria (1 listed)
- Non-Sensorineural Hearing Loss - Non-Functional Auditory Nerve - . Severe Mental or Cognitive Impairments
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 implantationAfter the surgery, patients typically undergo a period of recovery and healing. several factors including age at implantation, pre- and post-operative therapy, and parental involvement | Procedure or surgery | – |
Primary outcome
Post-Surgical Complication Rate: Infection, device failure,Measures auditory progression
Time frame: Baseline
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 26 Mar 2025.
Related trials for Cochlear Function Disorder
Recruiting
Restauration of the Auditory and Cognitive Functions in Cochlear Implanted Deaf Children in fNIRS
Deafness
Enrolling by invitation
Auditory-Cognitive Training to Optimize Outcomes for Older CI Users
Hearing Loss, Deafness
RecruitingObservational study
Cochlear Implant Recipients: Comprehensive Longitudinal Evaluation
Hearing Loss, Hearing Loss, Sensorineural
Recruiting
fNIRS in Pediatric Hearing Aids
Hearing Loss
Recruiting
Auditory Performances With Different Stimulation Depths in Cochlear Implanted Subjects Using a Fine Structure Strategy
Sensorineural Hearing Loss, Bilateral
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cochlear Function Disorder, run by Assiut University.
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 2 inclusion and 1 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: opening soon, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-Surgical Complication Rate: Infection, device failure,Measures auditory progression (time frame: Baseline). 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 26 Mar 2025.