Hearing LossPhase 2NCT01588925
Hearing Preservation Using Dexamethasone and Hyaluronic Acid for Cochlear Implantation
A Phase 2 study testing Cochlear Implantation, Cochlear Implantation+dexamethasone and Cochlear Implantation+dexamethasone+hyaluronic acid in people with Hearing Loss, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
The objective of the present study is to investigate the effect dexamethasone and hyaluronic acid have on hearing preservation Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Cochlear Implantation, Cochlear Implantation+dexamethasone and Cochlear Implantation+dexamethasone+hyaluronic acid
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2011to Jan 2014
- Phase
- Phase 2
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (greater than 18 years old) with severe/profound, bilateral sensorineural hearing loss with indication of cochlear implantation.
- Hearing thresholds better than 80 dB in 125 Hz, 90 dB in 250Hz and 100 dB in 500, 1000, 2000, 3000 and 4000 Hz in at least 3 of these frequencies
Who cannot join
- Malformation or cochlear ossification
- Developmental Disabilities
Trial locations and contacts
1 site in 1 country.
About this study
The objective of the present study is to investigate the effect dexamethasone and hyaluronic acid have on hearing preservation
Read the detailed description
Many efforts have been made to prevent residual hearing loss after cochlear implantation, such as the development of soft surgical techniques and pharmacological protection.
In this study we investigate whether the topical application of dexamethasone and hyaluronic acid prevents residual hearing loss.
- Conditions
- Hearing Loss
- Being tested
- Cochlear Implantation, Cochlear Implantation+dexamethasone, Cochlear Implantation+dexamethasone+hyaluronic acid
- Keywords
- Cochlear implantation, Dexamethasone, Acid, Hyaluronic
- Medical subject headings
- Hearing Loss, Heartburn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cochlear ImplantationDevice
Also called Hybrid L24 Implant
Cochlear implantation using Hybrid L24 Implant
Cochlear Implantation+dexamethasoneDrug
Also called Hybrid L24 Implant, Dexamethasone (4mg/ml)
Cochlear implantation using Hybrid L24 Implant,dexamethasone (4mg/ml) in the round window
Cochlear Implantation+dexamethasone+hyaluronic acidDrug
Also called Hybrid L24 Implant, Dexamethasone (4mg/ml), Hyaluronic acid (10mg/ml)
Cochlear implantation using Hybrid L24 Implant,dexamethasone (4mg/ml) in the round window and hyaluronic acid (10mg/ml) in the electrode array
| Study group | Role | What they receive |
|---|---|---|
| Control group | Experimental | Cochlear Implantation Receives: Device: Cochlear Implantation |
| Dexamethasone | Active comparator | Cochlear implantation using topical dexamethasone Receives: Device: Cochlear Implantation; Drug: Cochlear Implantation+dexamethasone |
| Dexamethasone+Hyaluronic acid | Active comparator | Cochlear implantation using topical dexamethasone associated with hyaluronic acid Receives: Device: Cochlear Implantation; Drug: Cochlear Implantation+dexamethasone+hyaluronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hearing thresholds
Hearing thresholds will be measured by audiometry in the frequencies 125, 250, 500, 1000, 2000 and 4000 Hz in the preoperatory, 1 month, 3 months and 6 months after the surgery.
Measured: within the first 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2012 (estimated)
- Study startNov 2011
- Primary completionFeb 2013
- Study completionJan 2014
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.
- More trials run by University of Sao Paulo General HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bernardo F Ramos, Principal investigator, University of São Paulo General HospitalRubens V Brito Neto, Study director, University of São Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01588925
- Sponsor's protocol ID
- 0297/11
- Status last verified
- Mar 2013
- First submitted
- 24 Apr 2012
- Last updated
- 3 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hearing Preservation Using Dexamethasone and Hyaluronic Acid for Cochlear Implantation
- ClinicalTrials.gov ID
- NCT01588925
- Acronym / sponsor ID
- 0297/11
- Conditions
- Hearing Loss
- Keywords
- Cochlear implantation, Dexamethasone, Acid, Hyaluronic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 1 May 2012 (estimated)
- 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 objective of the present study is to investigate the effect dexamethasone and hyaluronic acid have on hearing preservation
Detailed description
Many efforts have been made to prevent residual hearing loss after cochlear implantation, such as the development of soft surgical techniques and pharmacological protection.
In this study we investigate whether the topical application of dexamethasone and hyaluronic acid prevents residual hearing loss.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Experimental | Device: Cochlear ImplantationCochlear Implantation |
| Dexamethasone | Active comparator | Device: Cochlear Implantation, Drug: Cochlear Implantation+dexamethasoneCochlear implantation using topical dexamethasone |
| Dexamethasone+Hyaluronic acid | Active comparator | Device: Cochlear Implantation, Drug: Cochlear Implantation+dexamethasone+hyaluronic acidCochlear implantation using topical dexamethasone associated with hyaluronic acid |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults (greater than 18 years old) with severe/profound, bilateral sensorineural hearing loss with indication of cochlear implantation.
- Hearing thresholds better than 80 dB in 125 Hz, 90 dB in 250Hz and 100 dB in 500, 1000, 2000, 3000 and 4000 Hz in at least 3 of these frequencies
Key exclusion criteria (2 listed)
- Malformation or cochlear ossification
- Developmental Disabilities
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 ImplantationAlso: Hybrid L24 ImplantCochlear implantation using Hybrid L24 Implant | Device | Control group, Dexamethasone, Dexamethasone+Hyaluronic acid |
| Cochlear Implantation+dexamethasoneAlso: Hybrid L24 Implant, Dexamethasone (4mg/ml)Cochlear implantation using Hybrid L24 Implant,dexamethasone (4mg/ml) in the round window | Drug | Dexamethasone |
| Cochlear Implantation+dexamethasone+hyaluronic acidAlso: Hybrid L24 Implant, Dexamethasone (4mg/ml), Hyaluronic acid (10mg/ml)Cochlear implantation using Hybrid L24 Implant,dexamethasone (4mg/ml) in the round window and hyaluronic acid (10mg/ml) in the electrode array | Drug | Dexamethasone+Hyaluronic acid |
Primary outcome
Hearing thresholds
Time frame: within the first 6 months after surgery
Hearing thresholds will be measured by audiometry in the frequencies 125, 250, 500, 1000, 2000 and 4000 Hz in the preoperatory, 1 month, 3 months and 6 months after the surgery.
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 3 Oct 2014.
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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. This study is not recruiting at the moment.
Bernardo F Ramos principal investigator
University of São Paulo General Hospital
Rubens V Brito Neto study director
University of São Paulo General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cochlear Implantation, Cochlear Implantation+dexamethasone and Cochlear Implantation+dexamethasone+hyaluronic acid in people with Hearing Loss, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 3 Oct 2014. 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 Brazil. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Hearing thresholds (time frame: within the first 6 months after surgery). 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 3 Oct 2014.