Investigation of the Role of Steroids in Enhancing Voice Therapy Outcomes (AAO)
Primary Purpose
Dysphonia
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Steroid
Lactose Pills
Sponsored by
About this trial
This is an interventional treatment trial for Dysphonia
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)
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Steroid
Placebo
Arm Description
Prednizone pills. 4 day course 2 x 20mg per day.
Lactose Pills. 4 day course 2 x 20mg per day.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change in Lesion Size From 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.
Change in Voice Handicap Index (VHI) Scores From Baseline to 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
Number of Participants That Showed Improved (Lower) Average Decibels (db) Output.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02286960
Brief Title
Investigation of the Role of Steroids in Enhancing Voice Therapy Outcomes
Acronym
AAO
Official Title
Investigation of the Role of Steroids in Enhancing Voice Therapy Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphonia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Steroid
Arm Type
Active Comparator
Arm Description
Prednizone pills. 4 day course 2 x 20mg per day.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Lactose Pills. 4 day course 2 x 20mg per day.
Intervention Type
Drug
Intervention Name(s)
Steroid
Other Intervention Name(s)
Prednizone
Intervention Description
A short 4 day course is administered to the first group of patients with voice disorders before the initiation of voice therapy.
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactose Pills
Intervention Description
4 day course 2 x 20mg per da
Primary Outcome Measure Information:
Title
Change in Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) Score From Baseline to 2 Months
Description
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.
Time Frame
pre-treatment/baseline to 2 months
Secondary Outcome Measure Information:
Title
Change in Lesion Size From Baseline to 2 Months
Description
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.
Time Frame
pre-treatment/baseline to 2 months
Title
Change in Voice Handicap Index (VHI) Scores From Baseline to 2 Months.
Description
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
Time Frame
Pre-treatment/baseline to following treatment/2 months
Title
Number of Participants That Showed Improved (Lower) Average Decibels (db) Output.
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Milan Amin, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Investigation of the Role of Steroids in Enhancing Voice Therapy Outcomes
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