AAO: Investigation of the Role of Steroids in Enhancing Voice Therapy Outcomes

• Sponsor: NYU Langone Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT02286960
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Arms: 2
• Duration (Months): 65
• Patients Per Site Per Month: 0.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dysphonia	Drug: Steroid; Dietary Supplement: Lactose Pills	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 36 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: Jul 1, 2013
• Actual Primary Completion Date: Dec 1, 2018
• Actual Study Completion Date: Dec 1, 2018

Arms and Interventions

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 Names: 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

Outcome Measures

Primary Outcome Measures

1. Change in Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) Score From Baseline to 2 Months [pre-treatment/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

1. Change in Lesion Size From Baseline to 2 Months [pre-treatment/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.

2. Change in Voice Handicap Index (VHI) Scores From Baseline to 2 Months. [Pre-treatment/baseline to following treatment/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

3. Number of Participants That Showed Improved (Lower) Average Decibels (db) Output. [2 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York University School of Medicine	New York	New York	United States	10016

Sponsors and Collaborators

• NYU Langone Health

Investigators

• Principal Investigator: Milan Amin, MD, NYU Langone Health

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 19, 2013

More Information

Publications

None provided.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT02286960
• Other Study ID Numbers: 13-00096
• First Posted: Nov 10, 2014
• Last Update Posted: Mar 12, 2020
• Last Verified: Feb 1, 2020

• 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

Study Results

Participant Flow

Arm/Group Title	Steroid	Placebo
Arm/Group Description	Prednizone pills. 4 day course 2 x 20mg per day. Steroid: A short 4 day course is administered to the first group of patients with voice disorders before the initiation of voice therapy.	Lactose Pills. 4 day course 2 x 20mg per day. Lactose Pills: 4 day course 2 x 20mg per da
Period Title: Overall Study
STARTED	19	17
COMPLETED	16	14
NOT COMPLETED	3	3

Baseline Characteristics

Arm/Group Title	Steroid	Placebo	Total
Arm/Group Description	Prednizone pills. 4 day course 2 x 20mg per day. Steroid: A short 4 day course is administered to the first group of patients with voice disorders before the initiation of voice therapy.	Lactose Pills. 4 day course 2 x 20mg per day. Lactose Pills: 4 day course 2 x 20mg per da	Total of all reporting groups
Overall Participants	16	14	30
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	16 100%	14 100%	30 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	14 87.5%	13 92.9%	27 90%
Male	2 12.5%	1 7.1%	3 10%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 6.3%	0 0%	1 3.3%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	2 12.5%	0 0%	2 6.7%
White	10 62.5%	12 85.7%	22 73.3%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	3 18.8%	2 14.3%	5 16.7%
Region of Enrollment (Count of Participants)
United States	16 100%	14 100%	30 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Steroid	Placebo
Arm/Group Description	Prednizone pills. 4 day course 2 x 20mg per day. Steroid: A short 4 day course is administered to the first group of patients with voice disorders before the initiation of voice therapy.	Lactose Pills. 4 day course 2 x 20mg per day. Lactose Pills: 4 day course 2 x 20mg per da
Measure Participants	14	13
Mean (Standard Deviation) [score on a scale]	0.72 (0.21)	0.65 (0.14)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Steroid	Placebo
Arm/Group Description	Prednizone pills. 4 day course 2 x 20mg per day. Steroid: A short 4 day course is administered to the first group of patients with voice disorders before the initiation of voice therapy.	Lactose Pills. 4 day course 2 x 20mg per day. Lactose Pills: 4 day course 2 x 20mg per da
Measure Participants	14	13
Mean (Standard Deviation) [mm]	-0.4694 (0.5494)	0.2788 (0.3026)

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Steroid	Placebo
Arm/Group Description	Prednizone pills. 4 day course 2 x 20mg per day. Steroid: A short 4 day course is administered to the first group of patients with voice disorders before the initiation of voice therapy.	Lactose Pills. 4 day course 2 x 20mg per day. Lactose Pills: 4 day course 2 x 20mg per da
Measure Participants	14	13
Mean (Full Range) [score on a scale]	0.35	0.40

4. Secondary Outcome

Title	Number of Participants That Showed Improved (Lower) Average Decibels (db) Output.
Time Frame	2 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Steroid	Placebo
Arm/Group Description	Prednizone pills. 4 day course 2 x 20mg per day. Steroid: A short 4 day course is administered to the first group of patients with voice disorders before the initiation of voice therapy.	Lactose Pills. 4 day course 2 x 20mg per day. Lactose Pills: 4 day course 2 x 20mg per da
Measure Participants	14	13
Count of Participants [Participants]	14 87.5%	13 92.9%

Adverse Events

Time Frame	2 Months
Arm/Group Title	Steroid		Placebo
Arm/Group Description	Prednizone pills. 4 day course 2 x 20mg per day. Steroid: A short 4 day course is administered to the first group of patients with voice disorders before the initiation of voice therapy.		Lactose Pills. 4 day course 2 x 20mg per day. Lactose Pills: 4 day course 2 x 20mg per da
All Cause Mortality
	Steroid		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/14 (0%)
Serious Adverse Events
	Steroid		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/14 (0%)
Other (Not Including Serious) Adverse Events
	Steroid		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/14 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.