Age effects on cochlear reflectance in adult humans Save

Date Added
February 13th, 2017
PRO Number
Pro00061210
Researcher
Sara Fultz
Keywords
Aging, Ears, Geriatrics, Healthy Volunteer Studies, Hearing, Minorities
Summary

This project, funded by the National Institutes of Health, is being conducted to learn how structures of the middle-ear and inner ear are affected by age and hearing ability, and to provide a scientific basis for diagnosis and rehabilitation of hearing loss. Volunteers who meet the eligibility requirements may enroll in this study, which will include measurements of hearing using several procedures. Participants 18 years of age and older with normal hearing or hearing loss are currently being recruited. One or two visits of 1.5 to 2 hours are required and scheduling is flexible. Compensation for time will be provided and parking validated.

Institution
MUSC
Recruitment Contact
Sara Fultz
843-792-0667
fultzs@musc.edu

A PROSPECTIVE, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, MULTICENTER, PHASE 3 EFFICACY AND SAFETY STUDY OF OTO-104 GIVEN AS A SINGLE INTRATYMPANIC INJECTION IN SUBJECTS WITH UNILATERAL MENIERE?S DISEASE Save

Date Added
November 24th, 2015
PRO Number
Pro00049965
Researcher
Paul Lambert
Keywords
Ears
Summary

This is a randomized, double blind, placebo-controlled, multicenter 16-week Phase 3 study. Following an initial 4-week lead-in period, eligible subjects will be randomly assigned to either 12 mg OTO-104 or placebo using a 1:1 allocation ratio stratified by gender. Subjects will be observed for 12 weeks following a single intratympanic injection of either 12 mg OTO-104 or placebo.
The duration of the study for each subject will be a maximum of approximately 16 weeks, including a 4-week lead-in period before dosing (a single injection), followed by a 12-week follow-up period.
After screening (Visit 1), all eligible subjects will enter into a 4-week lead-in period. During the lead-in period, subjects will record their daily vertigo experience to allow for a baseline assessment of these events. Any day with a recorded definitive vertigo episode, an episode lasting at least 20 minutes (corresponding to a Vertigo Severity Score of 2 or more), will be defined as a definitive vertigo day (DVD). Following the lead-in period, eligible subjects will be randomized to 12 mg OTO-104 or placebo using a 1:1 allocation ratio.
After a single intratympanic injection with OTO-104 or placebo on Day 1, subjects will continue to record their daily vertigo experience during the 12-week follow-up period. Subjects will visit the study site at Weeks 4 and 8 for additional efficacy and safety assessments. Efficacy and safety assessments will also be completed at the end of study (Week 12) or upon early discontinuation from the study.

Institution
MUSC
Recruitment Contact
John Muus
843-300-8544
muus@musc.edu

Auditory Analysis and Speech Recognition Save

Date Added
January 21st, 2015
IRB Number
E-755R
Researcher
Judy Dubno
Keywords
Ears, Hearing
Summary

This project, funded by the National Institutes of Health, is being conducted to learn how hearing impairment affects how people hear certain sounds and understand speech and to provide a scientific basis for diagnosis and rehabilitation of hearing loss. Volunteers who meet the eligibility requirements may enroll in this study, which will include measurements of hearing tones and noise, understanding speech, and completing questionnaires. Participants 18 years of age and older with normal hearing or hearing loss are currently being recruited. Several visits of 1.5-2 hours each over a period of 3-6 weeks are required and scheduling is flexible. Compensation for time will be provided and parking validated.

Institution
MUSC
Recruitment Contact
Sara Fultz
843- 792-0667
fultzs@musc.edu

Multi-site study of the efficacy of speech perception training for hearing-aid users Save

Date Added
January 16th, 2015
IRB Number
20166
Researcher
Judy Dubno
Keywords
Aging, Ears, Hearing, Minorities
Summary

This project, funded by the National Institutes of Health, is recruiting participants for a multi-site study evaluating an auditory training program for people who use hearing aids. This study includes a hearing evaluation, several listening tasks, and 30 hours of participation in a computer-based speech-training program. Native English speakers between the ages of 35 and 89 who have worn hearing aids for at least the past 3 months are currently being recruited. The study requires at least 2 visits per week for a period of 12-15 weeks, scheduled at the participant’s convenience. Compensation for time will be provided and parking validated.

Institution
MUSC
Recruitment Contact
Sara Fultz
843- 792-0667
fultzs@musc.edu

Auditory Perception and Discrimination with Competing Signals Save

Date Added
February 5th, 2014
PRO Number
Pro00031785
Researcher
Will Bologna
Keywords
Ears, Hearing
Summary

I am looking for native speakers of American English who have normal hearing and are either 18-30 or 60-89 years old. Participants will listen to speech or non-speech sounds and make judgements on what they hear. At times, distracting sounds will be present and must be ignored. The goal of the study is to understand how listeners distinguish relevant from irrelevant sounds, and how attention is directed to a chosen sounds in favor of others. Study sessions are 1.5-2 hours long, with breaks given as needed. Compensation for time and effort will be provided.

Institution
MUSC
Recruitment Contact
Will Bologna
(843) 792-0667
bologna@musc.edu

Experimental and Clinical Studies of Presbyacusis Save

Date Added
October 5th, 2009
IRB Number
E-607R
Researcher
Judy Dubno
Keywords
Aging, Brain, Ears, Geriatrics, Healthy Volunteer Studies, Hearing, Minorities
Summary

This project, funded by the National Institutes of Health, is being conducted to determine the effects of aging on hearing, understanding speech, and brain functions. This study will provide a scientific basis for diagnosis, rehabilitation and prevention of hearing loss due to aging. Volunteers who meet the eligibility requirements may enroll in this study, which will include measurements of hearing, making listening judgments of sounds, behavioral tasks, questionnaires, and MRI scanning of the brain. Participants 60 years of age and older with normal hearing or hearing loss are currently being recruited. Three visits of 2-3 hours each are required and scheduling is flexible.

Institution
MUSC
Recruitment Contact
Amanda Maxwell
843-792-5916
maxwelam@musc.edu

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