Active Clinical Studies

This page provides an up-to-date listing of the active clinical studies being performed in the Division of Otolaryngology at the University of Wisconsin Clinical Science Center. When available information about participating in the study will follow the description. The participation information is in .pdf format. You will need Adobe Acrobat® Reader to view them, if you do not have this software it can be downloaded free, here.

1. Voice-related quality of life in dysphonic children

Principal Investigator: Diane G. Heatley, MD
Supported by the National Institute on Deafness and Other Communication Disorders

Information about the active grant supporting this study.

Over 1 million children in the United States are thought to have hoarse voices. Hoarseness may have a negative effect on performance in school, ability to communicate effectively, social development and self-esteem. However, there have been few studies on the effect of vocal hoarseness on a child’s quality of life and it is unknown how treating a voice disorder with voice therapy or other methods can impact a child’s life. There are no published or valid questionnaires for examining voice-related quality of life in children of different ages. The long-term goal of our research is to understand the mechanisms of childhood hoarseness, to develop good treatment methods, and to effectively assess treatment outcomes. The first aim of our study is to develop a reliable, age-appropriate, and valid questionnaire for assessing voice-related quality of life in toddlers (ages 2-4), young children (ages 5-7), school age children (ages 8-12) and adolescents (ages 13-18). The second aim is to use the new questionnaire to determine how voice disorders in children are related to a child’s quality of life and perception of general health. A voice evaluation by a speech-language pathologist, a general health questionnaire for children, and our voice questionnaire will be completed in children with hoarse voices and in children without voice disorders who will serve as controls.

For more information about participating in this research, click here.

2. Quantifying effects of treatment of pediatric dysphonia

Principal Investigator: J. Scott McMurray, MD

The diagnosis and management of childhood dysphonia is a significant clinical problem. However, there have been few studies aimed at defining standard assessment methods for pediatric dysphonia. Our objective is to define assessment methods that are appropriate for use in determining response to treatment in dysphonic children. Our main focus, therefore, is the issue of assessment responsivity. The first specific aim is to develop a set of responsive measures of vocal pathology in school-aged children by inducing short-term change in vocal status via behavioral and medical management of extraesophageal reflux disease (EERD). Because we are treating children suspected of EERD, this study also presents the opportunity for examining the benefits of combined vocal hygiene and medical management in the treatment of pediatric EERD. Accordingly, our second specific aim is to determine predictive criteria for improvement in vocal status in dysphonic children suspected of EERD. Our hypothesis is that a particular set of measurements will emerge as particularly responsive to change in vocal pathology in this population, and will allow for informed prediction of degree of improvement with treatment.

3. Picibanil Schlerotherapy (OK-432): A multicenter trial

Principal Investigator (University of Wisconsin site): J. Scott McMurray
Host Site: The University of Iowa, Department of Otolaryngology-Head and Neck Surgery, Dr. Richard Smith

Lymphangiomas or cystic hygromas represent localized malformations in the development of the lymphatic system. They typically present in children under 2 years of age and, in almost 50% of the cases, are diagnosed at birth. Traditional therapy for lymphangiomas has been surgical removal, which is associated with a low recurrence rate (0-25%). However, this goal often cannot be achieved in the head and neck without sacrificing functionally important structures. Incomplete excision is associated with a high recurrence rate (35%-100%). Some forms of sclerotherapy may be an effective form of treatment. One such agent, an investigational medication known as Picibanil (OK 432), has been shown to be effective in other countries and the preliminary results within the United States have been promising. An investigational drug is one that has not yet been approved by the Food and Drug Administration (FDA) for commercial use and is available for research use only. We are part of a multi institutional trial to confirm the safety and effectiveness of Picibanil. Children (ages 6 months to 18 years) with a diagnosis of macrocystic lymphangioma (cystic hygroma) of the head and neck are study participants and are assigned to either ”Immediate Treatment” or “Delayed Treatment” groups. Subjects will receive Picibanil injections into the macrocystic regions over the course of one year. Pre-, concurrent, and post-treatment examinations will be performed.

For more information about participating in this research, click here.

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First published: 07/15/02 Last updated: 11/07/09 webmaster@surgery.wisc.edu
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