A Phase 1 interventional study of resonant voice and voice rest in Acute Phonotrauma, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-01-25.
Sponsored by University of Pittsburgh · Phase 1, Interventional, and Basic science
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).
3,439 studies on the registry are indexed under Inflammation; 629 are open to participants now.
This study's enrollment of 45 is close to the median of 50 across 2,436 interventional studies indexed under Inflammation.
Browse Inflammation studies →University of Pittsburgh is the lead sponsor of 1,385 studies on the registry; 167 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.
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Exclusion Criteria:
Behavioral: resonant voice · Behavioral: Breathy voice · Behavioral: Relaxation exercise · Behavioral: Resonant voice and relaxation exercise
Behavioral: voice rest
A 4-hr resonant voice exercise will be prescribed to subjects following vocal loading.
A 4-hr voice rest will be prescribed to subjects following vocal loading.
A 4-hr breathy voice exercise will be prescribed to subjects following vocal loading.
A 4-hr relaxation exercise will be prescribed to subjects following vocal loading.
Also known as: meditation
A 4-hr resonant voice and relaxation exercise will be prescribed to subjects following vocal loading.
Also known as: Resonant voice and meditation exercise
Biomarker levels in laryngeal secretion
Time frame: up to 2 months
This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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University of Pittsburgh