Hearing Loss Clinical Trial
Official title:
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SPI-1005 in Adults Receiving a Cochlear Implant
The goal of this clinical trial is to learn about the effects of drug SPI-1005 in adults receiving a cochlear implant with a long electrode array (FLEX26 or greater) from MED-EL Cochlear Implant Systems into one ear. The main question this clinical trial aims to answer is: Is drug SPI-1005 safe and well-tolerated in adults receiving a cochlear implant, and/or what medical problems might participants experience when taking drug SPI-1005? The clinical trial will also measure the effects of SPI-1005 on hearing, word recognition, speech discrimination, tinnitus, and vertigo outcomes after receiving a cochlear implant. The purpose for this and future clinical trials is to learn whether SPI-1005 can prevent or treat these side effects after receiving a cochlear implant. Participants will take drug SPI-1005 or placebo (a look-alike substance that contains no drug) for 6 months, starting 2 days before receiving the cochlear implant. There are 5 required in-clinic visits over 6 months for audiology and other tests. The effects of SPI-1005 will be compared to the placebo (the look-alike substance that contains no drug) to study what effects SPI-1005 might have.
n/a
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04696835 -
fNIRS in Pediatric Hearing Aids
|
N/A | |
Completed |
NCT03662256 -
Reducing Childhood Hearing Loss in Rural Alaska Through a Preschool Screening and Referral Process Using Mobile Health and Telemedicine
|
N/A | |
Completed |
NCT04602780 -
Evaluating the Revised WORQ in CI Users
|
||
Completed |
NCT03723161 -
Evaluation of the Ponto Bone Anchored Hearing System in a Pediatric Atresia Population
|
||
Completed |
NCT05086809 -
Investigation of an Updated Bone-anchored Sound Processor
|
N/A | |
Active, not recruiting |
NCT03548779 -
North Carolina Genomic Evaluation by Next-generation Exome Sequencing, 2
|
N/A | |
Completed |
NCT03428841 -
Audiovisual Assessment After Dural Puncture During Epidural Placement in Obstetric Patients
|
N/A | |
Completed |
NCT04559282 -
Home Test of New Sound Processor
|
N/A | |
Enrolling by invitation |
NCT03345654 -
Individually-guided Hearing Aid Fitting
|
||
Completed |
NCT06016335 -
MRI-based Synthetic CT Images of the Head and Neck
|
N/A | |
Completed |
NCT05165121 -
Comparison of Hearing Aid Fitting Outcomes Between Self-fit and Professional Fit for MDHearing Smart Hearing Aids
|
N/A | |
Recruiting |
NCT05533840 -
Establishment and Application of a New Imaging System for Otology Based on Ultra-high Resolution CT
|
||
Completed |
NCT04622059 -
AUditive Direct In-utero Observation (AUDIO): Prenatal Testing of Congenital Hypoacusis
|
N/A | |
Terminated |
NCT02294812 -
Effects of Cognitive Training on Speech Perception
|
N/A | |
Recruiting |
NCT02558478 -
Identification of New Genes Implicated in Rare Neurosensory Diseases by Whole Exome Sequencing
|
N/A | |
Withdrawn |
NCT02740322 -
Validating the Hum Test
|
N/A | |
Completed |
NCT01963104 -
Community-Based Kiosks for Hearing Screening and Education
|
N/A | |
Completed |
NCT01857661 -
The Influence of the Sound Generator Combined With Conventional Amplification for Tinnitus Control: Blind Randomized Clinical Trial
|
N/A | |
Completed |
NCT01892007 -
Evaluation of Cogmed Working Memory Training for Adult Hearing Aid Users
|
N/A | |
Withdrawn |
NCT01223638 -
The Prevalence of Hearing Loss Among Children With Congenital Hypothyroidism
|
N/A |