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Completed

NCT Number: NCT02286960

Investigation of the Role of Steroids in Enhancing Voice Therapy Outcomes

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.

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Key information

Conditions

Dysphonia Laryngeal Diseases Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms Voice Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

New York University School of Medicine

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Steroid

Drug

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

Lactose Pills

Dietary Supplement

4 day course 2 x 20mg per da

Primary outcomes

  1. Change in Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) Score From Baseline to 2 Months

    Time frame: pre-treatment/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.

Secondary outcomes

  1. Change in Lesion Size From Baseline to 2 Months

    Time frame: pre-treatment/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.

  2. Change in Voice Handicap Index (VHI) Scores From Baseline to 2 Months.

    Time frame: Pre-treatment/baseline to following treatment/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

  3. Number of Participants That Showed Improved (Lower) Average Decibels (db) Output.

    Time frame: 2 months

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Acronym: AAO

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Nov 10, 2014
Registry last updated
Mar 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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