Hearing Loss, SensorineuralNCT04397354
Intracochlear Dexamethasone Application During Cochlear Implantation for Preserving Cochlear Cells
A study testing Intracochlear Dexamethasone and Intratympanic Dexamethasone in people with Hearing Loss, Sensorineural, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
The protection of cochlear cells is one of the main concerns of cochlear implant surgery. New electrode designs or additional molecules have been used for this purpose. The aim of the study is to test the effect of dexamethasone in two different application methods. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hearing Loss, Sensorineural
- What is being tested?
- Intracochlear Dexamethasone and Intratympanic Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Mar 2020to 20 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Patients with sensorineural hearing loss
- Patients who will have cochlear implant surgery with CI422 electrode
Who cannot join
- Patients with cochlear abnormality
- Patients with auditory neuropathy
Trial locations and contacts
1 site in 1 country.
About this study
The protection of cochlear cells is one of the main concerns of cochlear implant surgery. New electrode designs or additional molecules have been used for this purpose. The aim of the study is to test the effect of dexamethasone in two different application methods.
Read the detailed description
The protection of cochlear cells is one of the main concerns of cochlear implant surgery. New electrode designs or additional molecules have been used for this purpose. The aim of the study is to test the effect of dexamethasone in two different application methods. Participants who will have cochlear implant surgery will be divided into three groups. Group 1 will have intracochlear dexamethasone after the incision of the round window membrane. Group 2 will have intratympanic dexamethasone after the incision of the round window membrane. Group 3 will serve as a control group. All participants will be tested after a week, a month, 3, and 6 months. Impedance and threshold measurements will be compared.
- Conditions
- Hearing Loss, Sensorineural
- Being tested
- Intracochlear Dexamethasone, Intratympanic Dexamethasone, No additional drugs(control Group)
- Keywords
- cochlear implant, dexamethasone
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracochlear DexamethasoneDrug
Also called intracochlear
intracochlear injection of dexamethasone with cochlear implantation
Intratympanic DexamethasoneDrug
Also called intratympanic
intratympanic injection of dexamethasone with cochlear implantation
No additional drugs(control Group)Drug
Also called No drugs
Control group: No drugs will be injected middle ear with cochlear implantation
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | intracochlear dexamethasone application during cochlear implantation Receives: Drug: Intracochlear Dexamethasone |
| Group 2 | Active comparator | intratympanic dexamethasone application during cochlear implantation Receives: Drug: Intratympanic Dexamethasone |
| Group 3 | Sham comparator | No drugs during cochlear implantation Receives: Drug: No additional drugs(control Group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electrode Impedance(Ohm)
All intra-operative impedance values will be acquired after surgery. They will be repeated in first and 3 rd months
Measured: 1-3 months
Electrode thresholds(CL)
All intra-operative thresholds will be acquired after surgery. They will be repeated in first and 3 rd months
Measured: 1-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start2 Mar 2020
- Primary completion1 Aug 2022
- Study completion20 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, SensorineuralStudies of the same condition, open and under way.
- More trials run by Pamukkale 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fazıl Necdet Ardıç, Pamukkale University
- Investigators
- Fazil N Ardic, MD, Principal investigator, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04397354
- Sponsor's protocol ID
- 2
- Status last verified
- Jun 2022
- First submitted
- 13 May 2020
- Last updated
- 4 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The metadata will be shared by a public depository.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracochlear Dexamethasone Application During Cochlear Implantation for Preserving Cochlear Cells
- ClinicalTrials.gov ID
- NCT04397354
- Acronym / sponsor ID
- 2
- Conditions
- Hearing Loss, Sensorineural
- Keywords
- cochlear implant, dexamethasone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 2 Mar 2020 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 20 Sep 2022 (actual)
- First posted
- 21 May 2020 (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.
The protection of cochlear cells is one of the main concerns of cochlear implant surgery. New electrode designs or additional molecules have been used for this purpose. The aim of the study is to test the effect of dexamethasone in two different application methods.
Detailed description
The protection of cochlear cells is one of the main concerns of cochlear implant surgery. New electrode designs or additional molecules have been used for this purpose. The aim of the study is to test the effect of dexamethasone in two different application methods. Participants who will have cochlear implant surgery will be divided into three groups. Group 1 will have intracochlear dexamethasone after the incision of the round window membrane. Group 2 will have intratympanic dexamethasone after the incision of the round window membrane. Group 3 will serve as a control group. All participants will be tested after a week, a month, 3, and 6 months. Impedance and threshold measurements will be compared.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Prospective, randomized
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: Intracochlear Dexamethasoneintracochlear dexamethasone application during cochlear implantation |
| Group 2 | Active comparator | Drug: Intratympanic Dexamethasoneintratympanic dexamethasone application during cochlear implantation |
| Group 3 | Sham comparator | Drug: No additional drugs(control Group)No drugs during cochlear implantation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with sensorineural hearing loss
- Patients who will have cochlear implant surgery with CI422 electrode
Key exclusion criteria (2 listed)
- Patients with cochlear abnormality
- Patients with auditory neuropathy
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 |
|---|---|---|
| Intracochlear DexamethasoneAlso: intracochlearintracochlear injection of dexamethasone with cochlear implantation | Drug | Group 1 |
| Intratympanic DexamethasoneAlso: intratympanicintratympanic injection of dexamethasone with cochlear implantation | Drug | Group 2 |
| No additional drugs(control Group)Also: No drugsControl group: No drugs will be injected middle ear with cochlear implantation | Drug | Group 3 |
Primary outcome
Electrode Impedance(Ohm)
Time frame: 1-3 months
All intra-operative impedance values will be acquired after surgery. They will be repeated in first and 3 rd months
Electrode thresholds(CL)
Time frame: 1-3 months
All intra-operative thresholds will be acquired after surgery. They will be repeated in first and 3 rd months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
- Individual participant dataSharing planned: No. The metadata will be shared by a public depository.
Related trials for Hearing Loss, Sensorineural
Recruiting
Barriers and Facilitators to OTC Hearing Aids Success
Hearing Loss, Sensorineural, Presbycusis
Enrolling by invitationObservational study
Post-Market Registry Study for Vibrant Hearing Solutions
Conductive Hearing Loss, Mixed Hearing Loss
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Enrolling by invitationObservational study
Comparing an AI-driven Hearing Test With the Standard Hearing Test in Adults With Hearing Loss and Tinnitus
Sensorineural Hearing Loss, Tinnitus
Not yet recruiting
Effect of a Totally Implantable Cochlear Implant on Tinnitus Severity in Adults With Preoperative Tinnitus
Sensorineural Hearing Loss, Tinnitus
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. This study is not recruiting at the moment.
Fazil N Ardic, MD principal investigator
Pamukkale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intracochlear Dexamethasone and Intratympanic Dexamethasone in people with Hearing Loss, Sensorineural, run by Pamukkale University at 1 site in Turkey (Türkiye).
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 2 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: finished, as of the sponsor's last update on 4 Jan 2023. 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Electrode Impedance(Ohm) (time frame: 1-3 months). The study lists 2 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 4 Jan 2023.