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

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ClinicalTrials.gov Identifier: NCT02286960
Recruitment Status : Recruiting
First Posted : November 10, 2014
Last Update Posted : February 2, 2018
Sponsor:
Information provided by (Responsible Party):
New York University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Dysphonia Drug: Steroid Dietary Supplement: Lactose Pills Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Investigation of the Role of Steroids in Enhancing Voice Therapy Outcomes
Study Start Date : July 2013
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

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 Name: 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




Primary Outcome Measures :
  1. Audio Perceptual Analysis [ Time Frame: 2 months ]
    The CAPE-V stimuli will be analyzed using a visual analog scale with expert listeners


Secondary Outcome Measures :
  1. Video-Perceptual Analysis [ Time Frame: 2 months ]
    Analysis of stroboscopic parameters by expert raters as well as quantification of lesion size.

  2. Change in VHI scores (Voice Handicap Index-10) [ Time Frame: 2 months ]
    a change in VHI-10 scores from pre-treatment to following treatment

  3. Aerodynamic Voice Analysis [ Time Frame: 2 months ]
    Collection of acoustic output and pulmonary pressure during labial phonetic tasks



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02286960


Contacts
Contact: Kristin Montella, MD 212 263 8182 Kristin.Montella@nyumc.org

Locations
United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Milan Amin, MD    646-754-1204    milan.amin@nyumc.org   
Contact: Ryan Branski, PhD    646-754-1205    ryan.branski@nyumc.org   
Sub-Investigator: Efstratios Achlatis, MD         
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: Milan Amin, MD New York University School of Medicine

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT02286960     History of Changes
Other Study ID Numbers: 13-00096
First Posted: November 10, 2014    Key Record Dates
Last Update Posted: February 2, 2018
Last Verified: January 2018

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

Additional relevant MeSH terms:
Dysphonia
Voice Disorders
Laryngeal Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms