Hearing Preservation Using Dexamethasone and Hyaluronic Acid for Cochlear Implantation

Study Overview
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Brief Summary
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The objective of the present study is to investigate the effect dexamethasone and hyaluronic acid have on hearing preservation

Detailed Description
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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.

Official Title
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Hearing Preservation Using Dexamethasone and Hyaluronic Acid for Cochlear Implantation

Conditions
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Hearing Loss

Intervention / Treatment
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* Device: Cochlear Implantation
* Drug: Cochlear Implantation+dexamethasone
* Drug: Cochlear Implantation+dexamethasone+hyaluronic acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Malformation or cochlear ossification Developmental Disabilities

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control group<br>Cochlear Implantation | Device: Cochlear Implantation<br>* Cochlear implantation using Hybrid L24 Implant<br>* Other names: Hybrid L24 Implant;|
| Active Comparator: Dexamethasone<br>Cochlear implantation using topical dexamethasone | Device: Cochlear Implantation<br>* Cochlear implantation using Hybrid L24 Implant<br>* Other names: Hybrid L24 Implant;Drug: Cochlear Implantation+dexamethasone<br>* Cochlear implantation using Hybrid L24 Implant,dexamethasone (4mg/ml) in the round window<br>* Other names: Dexamethasone (4mg/ml);|
| Active Comparator: Dexamethasone+Hyaluronic acid<br>Cochlear implantation using topical dexamethasone associated with hyaluronic acid | Device: Cochlear Implantation<br>* Cochlear implantation using Hybrid L24 Implant<br>* Other names: Hybrid L24 Implant;Drug: Cochlear Implantation+dexamethasone+hyaluronic acid<br>* Cochlear implantation using Hybrid L24 Implant,dexamethasone (4mg/ml) in the round window and hyaluronic acid (10mg/ml) in the electrode array<br>* Other names: Hyaluronic acid (10mg/ml);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | within the first 6 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cochlear implantation, Dexamethasone, Acid, Hyaluronic