Investigation of the Role of Steroids in Enhancing Voice Therapy Outcomes (AAO)

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.

Study Overview

• Status: Completed
• Conditions: Dysphonia
• Intervention / Treatment: Drug: Steroid; Dietary supplement: Lactose Pills

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 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 measurements that will be collected in all these phases are the Voice Handicap Index (VHI)-10 , the noise to harmonic ratio H/N, the fundamental frequency Fo, The transglottic airflow and subglottic pressure. 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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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 Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Steroid; Prednizone pills. 4 day course 2 x 20mg per day.	Drug: Steroid; A short 4 day course is administered to the first group of patients with voice disorders before the initiation of voice therapy.; Other Names: Prednizone
Placebo Comparator: Placebo; Lactose Pills. 4 day course 2 x 20mg per day.	Dietary supplement: Lactose Pills; 4 day course 2 x 20mg per da

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) Score From Baseline to 2 Months	Data will be collected via measurement of the hatchmark on the 100mm line for each variable (e.g. 72/100). The higher the score, the higher the deviancy. The final score is the average of scores from each variable.	pre-treatment/baseline to 2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Lesion Size From Baseline to 2 Months	Still images of the glottis will be obtained from the video such that the vocal folds are captured in an open position (at least 40 degrees at the anterior commissure). Image J software (NIH) will then be used to outline the lesion and measure the length of the ipsilateral vocal fold.	pre-treatment/baseline to 2 months
Change in Voice Handicap Index (VHI) Scores From Baseline to 2 Months.	A change in VHI scores from pre-treatment to following treatment. Scores can range from 0-120: 0-30: Mild Minimal amount of handicap 31-60: Moderate Often seen in patients with vocal nodules, polyps, or cysts 60-120: Severe Often seen	Pre-treatment/baseline to following treatment/2 months
Number of Participants That Showed Improved (Lower) Average Decibels (db) Output.		2 months

Collaborators and Investigators

• Sponsor: NYU Langone Health

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: November 6, 2014
• First Submitted That Met QC Criteria: November 7, 2014
• First Posted (Estimate): November 10, 2014

Study Record Updates

• Last Update Posted (Actual): March 12, 2020
• Last Update Submitted That Met QC Criteria: February 27, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Laryngeal Diseases; Voice Disorders; Dysphonia
• Other Study ID Numbers: 13-00096

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No