Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.
Evaluation of Revised Indicatons (ERID) for Cochlear Implant Candidacy for the Adult CMS Population
Purpose: The purpose of this study is 1) to evaluate the safety and efficacy of currently
available multichannel cochlear implant systems for newly implanted adults with an indication
based on open-set sentence recognition that expand criteria currently used by Center for
Medicare & Medicaid Services (CMS), and 2) to assess the correlation between measures of
speech recognition in candidates for cochlear implants and their utility in predicting
audiologic and quality of life outcomes after implantation.
Participants: Adults (≥ 65 years of age) and CMS-eligible as a primary source of medical
insurance coverage.
Procedures (methods): Evaluate objective and subjective outcomes of cochlear implantation in
a patient population that does not meet current CMS candidacy criteria.
Call 214-648-5005 studyfinder@utsouthwestern.edu
Jacob Hunter
164787
All
65 Years and over
N/A
This study is also accepting healthy volunteers
NCT02075229
STU 112016-065
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Inclusion Criteria:
• Sixty-five years of age or older at the time of the study and CMS-eligible as primary
source of medical insurance coverage.
• Bilateral moderate to profound hearing loss in the low frequencies (up to 1000 Hz) and
profound sensorineural hearing loss in the high frequencies (3000 Hz and above).
• Preoperative aided sentence score in quiet greater than or equal to 40% correct but
less than or equal to 60% correct in the best aided condition on recorded AzBio
sentences.
• English spoken as the primary language.
Exclusion Criteria:
• Congenital hearing loss (for the purpose of this study, onset pror to 2 years-of-age).
• Preoperative aided sentence score less than 40% or greater than 60% correct in the
best aided condition on AzBio sentences in quiet
• Ossification, absence of cochlear development or any other cochlear anomaly that might
prevent complete insertion of the electrode array.
• Hearing loss of neural or central origin (e.g., deafness due to lesions on the
acoustic nerve or central auditory pathway).
• Active middle-ear infection.
• The audiologist and/or surgeon will review the study protocol with the patient prior
to having him/her sign the consent form. If the patient indicates he/she is unwilling
or unable to comply with all investigational requirements, he/she will not be enrolled
in the study.
• Using best clinical judgment based on professional interaction with the patient and
his/her family, the managing audiologist and surgeon will determine if there are any
disabling cognitive limitations that would prevent the patient from providing reliable
data for this study.
Device: Cochlear implant
Bilateral Sensorineural Hearing Loss
Cochlear Implant, Post-lingual onset hearing loss, Profound hearing loss, Low Frequency hearing loss, Profound sensorineural hearing loss, High frequency hearing loss, CMS-eligible patients
SPI-1005 for Prevention and Treatment of Aminoglycoside Induced Ototoxicity
The primary objective of this study is to determine the safety and tolerability of SPI-1005
treatment in CF patients with active pulmonary exacerbation that are receiving an IV course
of tobramycin, using histories, physical exams, vital signs (VS), adverse event (AE)
reporting, hematology (CBC) chemistry (Chem-20).
The secondary objectives of this study are to determine the pharmacokinetics of oral SPI-1005
at 200, 400 and 600 mg BID for 21 days. Peak/trough assessments will be determined for
ebselen, its major metabolite and selenium. Clinical assessments of the severity of
sensorineural hearing loss, speech discrimination, vertigo severity, tinnitus severity and
lung function will be made compared between treatment arms and the placebo arm of this study.
Call 214-648-5005 studyfinder@utsouthwestern.edu
Raksha Jain
19733
All
18 Years and over
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT02819856
STU 052017-042
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Inclusion Criteria:
• Cystic fibrosis patients about to receive IV tobramycin for acute pulmonary
exacerbation.
• Voluntarily consent to participate in the study.
• Females of childbearing potential should be using and committed to continue using one
of the following acceptable birth control methods:
• Sexual abstinence (inactivity) for 14 days prior to screening through study
completion; or IUD in place for at least 3 months prior to study through study
completion; or Barrier method (condom or diaphragm) with spermicide for at least 14
days prior to screening through study completion; or Stable hormonal contraceptive for
at least 3 months prior to study through study completion.
• Ability to perform all behavioral tests as indicated.
Exclusion Criteria:
• Current use or within 60 days prior to study enrollment the following IV ototoxic
medications: aminoglycoside antibiotics (gentamicin, tobramycin, amikacin,
streptomycin); platinum-containing chemotherapies (cisplatin, carboplatin,
oxaliplatin); or loop diuretic (furosemide).
• History of idiopathic sensorineural hearing loss, otosclerosis, or vestibular
schwannoma.
• History of middle ear or inner ear surgery.
• Current conductive hearing loss or middle ear effusion.
• Significant cardiovascular, hepatic, renal, hematologic, endocrine, immunologic, or
psychiatric disease.
• History of hypersensitivity or idiosyncratic reaction to compounds related to ebselen.
• Participation in another investigational drug or device study within 30 days prior to
study enrollment.
• Female patients who are pregnant or breastfeeding.