Clinical Trial: Investigation of the Role of Steroids in Enhancing Voice Therapy Outcomes

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Investigation of the Role of Steroids in Enhancing Voice Therapy Outcomes

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 Summary: 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.
Sponsor: New York University School of Medicine

Current Primary Outcome: Audio Perceptual Analysis [ Time Frame: 2 months ]

The CAPE-V stimuli will be analyzed using a visual analog scale with expert listeners


Original Primary Outcome:

  • Change in VHI scores (Voice Handicap Index-10) [ Time Frame: 2 months ]
    a change in VHI-10 scores from pre-treatment to following treatment
  • Video-Perceptual Analysis [ Time Frame: 2 months ]
    Analysis of stroboscopic parameters by expert raters as well as quantification of lesion size.
  • Audio Perceptual Analysis [ Time Frame: 2 months ]
    The CAPE-V stimuli will be analyzed using a visual analog scale with expert listeners
  • Aerodynamic Voice Analysis [ Time Frame: 2 months ]
    Collection of acoustic output and pulmonary pressure during labial phonetic tasks.


Current Secondary Outcome:

  • Video-Perceptual Analysis [ Time Frame: 2 months ]
    Analysis of stroboscopic parameters by expert raters as well as quantification of lesion size.
  • Change in VHI scores (Voice Handicap Index-10) [ Time Frame: 2 months ]
    a change in VHI-10 scores from pre-treatment to following treatment
  • Aerodynamic Voice Analysis [ Time Frame: 2 months ]
    Collection of acoustic output and pulmonary pressure during labial phonetic tasks


Original Secondary Outcome:

Information By: New York University School of Medicine

Dates:
Date Received: November 6, 2014
Date Started: July 2013
Date Completion: December 2017
Last Updated: October 11, 2016
Last Verified: October 2016