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Title
Randomized Controlled Trial of Voice Therapy on Children with Vocal Nodules
MEEI Protocol ID
10-04-024
NCT Number
NCT01255135
Condition
Vocal Nodules
Sponsor
National Institute on Deafness and Other Communication Disorders, NIH
Principal Investigator
Christopher Hartnick, M.D.
Study Design
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.
Study Objective
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.
Who is Eligible
Male and females between the ages of 6 to 10 years of age diagnosed with vocal nodules.
Subject Enrollment
We are currently enrolling individuals who have vocal nodules and meet study eligibility criteria.
Study Procedures
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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