Vocal fold nodules are common acquired benign mucosal lesions. Their etiology includes vocal behaviors that cause mucosal trauma and cofactors such as smoking and reflux. The voice disorders associated with nodules may result in significant handicaps. Treatment may include watchful waiting, voice therapy, medical management, and/or surgery. Voice therapy, a behavioral regimen, is the most common treatment modality for nodules. However, therapy efficacy data are scarce and insufficient to provide treatment guidelines. Therefore, the long-term objective of this research is to identify treatment protocols for vocal fold nodules that provide optimal and cost-effective outcomes. Voice therapy for patients with nodules is commonly a 6-12 week treatment regimen comprised of a vocal hygiene and a voice production component. Vocal hygiene is an informational program designed to reduce vocal demands and behaviors that can cause mucosal irritation. The voice production component trains new motor patterns to reduce mucosal trauma during speech. The relative efficacy of these two regimens is unclear. Therefore, the immediate goal of this application is to evaluate the relative efficacy of these voice therapy regimens in the treatment of vocal fold nodules in adults, using a 3-year, single-center randomized clinical trial design: i) vocal hygiene education (VH); ii) voice production (VP); and iii) watchful waiting control (WW). The VH and VP regimens will consist of six consecutive weekly 1/2 hour sessions. The primary outcome measures will be patient self-assessment and measured nodule size, and the secondary outcomes will be clinical assessment and acoustic data. All measures will be assessed on all subjects at baseline and at weeks 7 and 10. We hypothesize that VP therapy is more effective than VH therapy or WW.
The specific aim will test the hypothesis by determining the relative efficacy of the treatments with regard to the primary and the secondary outcome measures.

Agency
National Institute of Health (NIH)
Institute
National Institute on Deafness and Other Communication Disorders (NIDCD)
Type
Small Research Grants (R03)
Project #
5R03DC005550-04
Application #
6857120
Study Section
Special Emphasis Panel (ZDC1-SRB-O (22))
Program Officer
Shekim, Lana O
Project Start
2003-02-07
Project End
2007-01-31
Budget Start
2005-02-01
Budget End
2007-01-31
Support Year
4
Fiscal Year
2005
Total Cost
$71,750
Indirect Cost
Name
New York University
Department
Other Health Professions
Type
Schools of Education
DUNS #
041968306
City
New York
State
NY
Country
United States
Zip Code
10012