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Completed

NCT Number: NCT01588925

Hearing Preservation Using Dexamethasone and Hyaluronic Acid for Cochlear Implantation

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

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Key information

Conditions

Hearing Loss Ear Diseases Hearing Disorders Heartburn Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of São Paulo General Hospital

São Paulo, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cochlear implantation

Device

Cochlear implantation using Hybrid L24 Implant

Other names: Hybrid L24 Implant

Cochlear Implantation+dexamethasone

Drug

Cochlear implantation using Hybrid L24 Implant,dexamethasone (4mg/ml) in the round window

Other names: Hybrid L24 Implant, Dexamethasone (4mg/ml)

Cochlear Implantation+dexamethasone+hyaluronic acid

Drug

Cochlear implantation using Hybrid L24 Implant,dexamethasone (4mg/ml) in the round window and hyaluronic acid (10mg/ml) in the electrode array

Other names: Hybrid L24 Implant, Dexamethasone (4mg/ml), Hyaluronic acid (10mg/ml)

Primary outcomes

  1. 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.

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Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
May 1, 2012
Registry last updated
Oct 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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