Clinical trial NCT02286960: Investigation of the Role of Steroids in Enhancing Voice Therapy Outcomes
Official title: Investigation of the Role of Steroids in Enhancing Voice Therapy Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dysphonia
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2014-11-10
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) Score From Baseline to 2 Months
timeFrame: pre-treatment/baseline to 2 months
Secondary outcomes:
measure: Change in Lesion Size From Baseline to 2 Months
timeFrame: pre-treatment/baseline to 2 months
measure: Change in Voice Handicap Index (VHI) Scores From Baseline to 2 Months.
timeFrame: Pre-treatment/baseline to following treatment/2 months
measure: Number of Participants That Showed Improved (Lower) Average Decibels (db) Output.
timeFrame: 2 months
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Milan Amin, MD
role: PRINCIPAL_INVESTIGATOR
References: