Hybrid Model of Vocal Inflammation and Tissue Mobilization
Completed · Phase 1
Conditions studied: Acute Phonotrauma
In brief
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).
Key facts
- Study ID
- NCT01197339
- Run by
- University of Pittsburgh
- People needed
- 45
- Starts
- 2010-09-01
- Expected to finish
- 2013-03-01
- Last updated by the study team
- 2016-01-25
Who can join
Age: 18 and older, up to 40. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- healthy females
- ages 18-40
- generally healthy
- normal hearing bilaterally at 20 dB to 8,000 Hz
- have ability to produce "resonant voice" during training as determined by the examiner perceptually
- Tolerate rigid and nasal endoscopy without anesthesia to the larynx nasal patency allowing for the passage of an endoscope unilaterally
You may not qualify if…
- Smoking within the past five yr
- Failing a hearing screening test
- Having current chronic voice problems
- Having current medications that are determined to possibly influence voice
- Having heightened gag reflex
- Having known or suspected allergy to anesthetics
- Pregnancy reported
Where it is running
- Univesity of Pittsburgh — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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