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Investigation of the Role of Steroids in Enhancing Voice Therapy Outcomes

NCT02286960 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2020-03-12

Study results available
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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 steroids for the treatment of vocal fold lesions in a controlled manner. The specific aim of this study is to determine the effectiveness of of a short course of oral steroids prior to behavioral voice therapy in patients with benign, phonotraumatic vocal fold lesions. Enrolled subjects will be randomized using a random numbers table to either receive oral steroids or no steroids prior to the initiation of voice therapy. The therapist and individuals involved in the collection and analysis of data will be blinded as to whether the subject received drug. Prior to initiation of therapy subjects will be asked to return for an interval evaluation during which they undergo videostroboscopy and voice evaluation. Subjects will enter then the voice therapy phase . After an initial evaluation to determine the best mode of therapy they will receive a behavioral voice therapy course, which includes a range of behavioral modifications and motor learning techniques, along with lifestyle measures. In all these phases acoustic and aerodynamic measurements will be collected as well as audio-visual material from the videostroboscopic exams. The investigators hypothesize that oral steroids will lead to a reduction in lesion size, which will substantially aid in the delivery and incorporation of voice therapy techniques, contributing to the improvement of overall laryngeal biomechanics and providing an ideal starting point for behavioral voice therapy.

Conditions

  • Dysphonia

Interventions

DRUG

Steroid

A short 4 day course is administered to the first group of patients with voice disorders before the initiation of voice therapy.

DIETARY_SUPPLEMENT

Lactose Pills

4 day course 2 x 20mg per da

Sponsors & Collaborators

Principal Investigators

  • Milan Amin, MD · NYU Langone Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2018-12-31
Completion
2018-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02286960 on ClinicalTrials.gov