Investigation of the Role of Steroids in Enhancing Voice Therapy Outcomes

Dysphonia Clinical Trial

— AAO  

Official title:

Investigation of the Role of Steroids in Enhancing Voice Therapy Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02286960
• Other study ID #: 13-00096
• Status: Completed
• Phase: Phase 4
• Start date: July 2013
• Est. completion date: December 2018

Study information

• Verified date: February 2020
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Dysphonia

Intervention

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

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Number of Participants That Showed Improved (Lower) Average Decibels (db) Output.		2 months