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
|Condition or disease||Intervention/treatment||Phase|
|Dysphonia||Drug: Steroid Dietary Supplement: Lactose Pills||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|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|
Active Comparator: Steroid
Prednizone pills. 4 day course 2 x 20mg per day.
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
- Audio Perceptual Analysis [ Time Frame: 2 months ]The CAPE-V stimuli will be analyzed using a visual analog scale with expert listeners
- 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
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
|Contact: Kristin Montella, MD||212 263 8182||Kristin.Montella@nyumc.org|
|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 email@example.com|
|Contact: Ryan Branski, PhD 646-754-1205 firstname.lastname@example.org|
|Sub-Investigator: Efstratios Achlatis, MD|
|Principal Investigator:||Milan Amin, MD||New York University School of Medicine|