Status:
COMPLETED
Investigation of the Role of Steroids in Enhancing Voice Therapy Outcomes
Lead Sponsor:
NYU Langone Health
Conditions:
Dysphonia
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
Despite the considerable use of oral steroids in the regular management of benign vocal fold lesions there is little evidence base in the literature. This study will investigate the efficacy of oral s...
Detailed Description
The study will investigate the potential added advantage of the use of steroids in patients undergoing voice therapy. Enrolled subjects will be randomized using a random numbers table to either receiv...
Eligibility Criteria
Inclusion
- Age 18-80 males and females
- Presence of phonotraumatic lesion deemed to be etiologic for the complaint of dysphonia
- Voice therapy deemed to be the primary (or at least initial) treatment to address the dysphonia.
- Willingness to be an active participant in voice therapy.
Exclusion
- Use of any glucocorticoids (oral, inhaled, or intravenous) within 3 months of the initial evaluation
- Known allergy or hypersensitivity to oral steroids
- Active infection
- Diabetes Mellitus
- Prior history of radiation to the neck
- Recent myocardial infarction
- Recent gastrointestinal surgery with bowel anastamosis (3 months)
- Active peptic ulcer
- Pregnancy
- Severe depression or history of psycosis
- History of recent laryngeal surgery (within 12 months)
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT02286960
Start Date
July 1 2013
End Date
December 1 2018
Last Update
March 12 2020
Active Locations (1)
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1
New York University School of Medicine
New York, New York, United States, 10016