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NCT01197339 · ClinicalTrials.gov registry record · Phase 1
Hybrid Model of Vocal Inflammation and Tissue Mobilization
A Phase 1 study, sponsored by University of Pittsburgh.
- Completed
- Registry status
- Phase 1
- Development phase
- 45
- Enrollment target
NCT01197339 is a Phase 1 study that has completed, run by University of Pittsburgh. The registered enrollment target is 45 participants.
The verdict
NCT01197339, a Phase 1 study, has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 45 participants
- Enrollment target
Study Summary
The purpose of this study is to generate a technology that will allow clinicians to prescribe behavioral treatment that should optimize tissue healing for both acute and chronic phonotrauma. In this study, we propose to (1): establish a non-invasive methodology for estimating overall mechanical dose during phonation, and component metrics of phonatory mechanical dose (e.g., distance dose, energy dissipation dose and time dose) from high speed imaging data and aeromechanical modeling, for a range of vocal fold configurations (Experiment 1); (2): identify mathematical relations between treatment dose parameters, inflammatory state of the tissue and time-varying biological consequences in the tissue, up to 2 wk following acute phonotrauma (Experiment 2); (3): develop a hybrid physical-biological model of vocal fold inflammation and treatment to identify treatment modalities that should optimize post-traumatic wound healing at 2 wk, for a range of acute phonotraumatic conditions (Experiment 3-no human subject involved), and (4): provide a preliminary test of the hybrid treatment models' ability to predict idealized treatment outcome in human subjects, and calibrate the model as needed iteratively to achieve a match between predicted and obtained outcomes (Experiment 4).
Interventions
- BEHAVIORAL Breathy voice
- BEHAVIORAL resonant voice
- BEHAVIORAL voice rest
- BEHAVIORAL Relaxation exercise
- BEHAVIORAL Resonant voice and relaxation exercise
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2010-09 |
| Est. Completion | 2013-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01197339
The ClinicalTrials.gov registry entry for NCT01197339 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pittsburgh, which has 1,238 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Breathy voice is the first listed.
NCT01197339 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01197339 about?
NCT01197339 is a clinical study titled "Hybrid Model of Vocal Inflammation and Tissue Mobilization". The purpose of this study is to generate a technology that will allow clinicians to prescribe behavioral treatment that should optimize tissue healing for both acute and chronic phonotrauma. In this study, we propose to (1): establish a non-invasive methodology for estimating overall mechanical dose...
What is the current status of trial NCT01197339?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2010-09. Estimated completion is 2013-03.
What interventions are being tested in trial NCT01197339?
The interventions under investigation include: Breathy voice (BEHAVIORAL), resonant voice (BEHAVIORAL), voice rest (BEHAVIORAL), Relaxation exercise (BEHAVIORAL), Resonant voice and relaxation exercise (BEHAVIORAL).
Who is sponsoring clinical trial NCT01197339?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
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