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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: Completed Phase 1 study, sponsored by University of Pittsburgh.
NCT01197339 is a Phase 1 study that has completed, run by University of Pittsburgh. The registered enrollment target is 45 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT01197339 record still lists
NCT01197339 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower).
The record links to 0 conditions, and to 5 interventions - of which Breathy voice is the first listed.
NCT01197339 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01197339's enrollment target sits among peer trials
45 1066th of 2000 higher than 915 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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