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NCT02286960 · ClinicalTrials.gov registry record · Phase 4
Investigation of the Role of Steroids in Enhancing Voice Therapy Outcomes
A Phase 4 study, sponsored by NYU Langone Health.
- Completed
- Registry status
- Phase 4
- Development phase
- 36
- Enrollment target
NCT02286960 is a Phase 4 study that has completed, run by NYU Langone Health. The registered enrollment target is 36 participants.
The verdict
NCT02286960, a Phase 4 study, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 36 participants
- Enrollment target
Study 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.
Interventions
- DRUG Steroid
- DIETARY_SUPPLEMENT Lactose Pills
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2013-07 |
| Est. Completion | 2018-12 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02286960
The ClinicalTrials.gov registry entry for NCT02286960 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Steroid is the first listed.
NCT02286960 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02286960 about?
NCT02286960 is a clinical study titled "Investigation of the Role of Steroids in Enhancing Voice Therapy Outcomes". 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 stu...
What is the current status of trial NCT02286960?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 36 participants. The study started on 2013-07. Estimated completion is 2018-12.
What interventions are being tested in trial NCT02286960?
The interventions under investigation include: Steroid (DRUG), Lactose Pills (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT02286960?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
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