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Title
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Randomized Controlled Trial of Voice Therapy on Children with Vocal Nodules
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MEEI Protocol ID
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10-04-024
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NCT Number
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NCT01255135 |
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Condition
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Vocal Nodules
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Sponsor
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National Institute on Deafness and Other Communication Disorders, NIH
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Principal Investigator
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Christopher Hartnick, MD
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Study Design
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The current study is a randomized controlled multi-center trial of children with vocal fold nodules in two treatment arms. Subjects will receive vocal therapy for 6 to up to 12 weeks with a certified speech language pathologist to evaluate the efficacy of vocal therapy on children with vocal nodules.
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Study Objective
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The primary objectiveof this study is to determine the impact of voice therapy on voice-related quality of life in children age 6-10 years old with apparent vocal fold nodules, as measured by the validated Pediatric Voice-Related Quality of Life Instrument (PVRQOL) administered 4 weeks after completion of voice therapy.
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Who is Eligible
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Male and females between the ages of 6 to 10 years of age diagnosed with vocal nodules.
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Subject Enrollment
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We are currently enrolling individuals who have vocal nodules and meet study eligibility criteria.
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Study Procedures
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Subjects will undergo videostroboscopy or in some cases operative microsuspension laryngoscopy if in-office stroboscopy cannot be tolerated. They will also undergo aerodynamic and acoustic assessments as well as an audiology exam. If subjects qualify for the study, they will receive 6 to 12 weeks of vocal therapy with a certified speech language pathologist depending to which vocal therapy program they are randomly assigned.
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For More Information
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Christopher_hartnick@meei.harvard.edu
Vanessa_deguzman@meei.harvard.edu Vanessa De Guzman 617-573-3191 |
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Page updated 8/6//2012.
