Investigation of the Role of Steroids in Enhancing Voice Therapy Outcomes

NCT02286960 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 13-00096
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysphonia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in Lesion Size From Baseline to 2 Months

  pre-treatment/baseline to 2 months

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

  Pre-treatment/baseline to following treatment/2 months

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

  2 months

Study Arms (2)

Steroid

ACTIVE COMPARATOR

Prednizone pills. 4 day course 2 x 20mg per day.

Drug: Steroid

Placebo

PLACEBO COMPARATOR

Lactose Pills. 4 day course 2 x 20mg per day.

Dietary Supplement: Lactose Pills

Interventions

Steroid DRUG

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

Also known as: Prednizone

Steroid

Lactose Pills DIETARY_SUPPLEMENT

4 day course 2 x 20mg per da

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Dysphonia

Interventions

Steroids

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Milan Amin
• Organization: NYU Langone Health

Milan.Amin@nyulangone.org

646-754-1206

Study Officials

• Milan Amin, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2014
• First Posted: November 10, 2014
• Study Start: July 1, 2013
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: March 12, 2020
• Results First Posted: March 12, 2020

Record last verified: 2020-02

Locations

US (1)