Hybrid Model of Vocal Inflammation and Tissue Mobilization

Study Overview
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Brief Summary
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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).

Official Title
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Hybrid Model of Vocal Inflammation and Tissue Mobilization

Conditions
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Acute Phonotrauma

Intervention / Treatment
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* Behavioral: resonant voice
* Behavioral: voice rest
* Behavioral: Breathy voice
* Behavioral: Relaxation exercise
* Behavioral: Resonant voice and relaxation exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment<br> | Behavioral: resonant voice<br>* A 4-hr resonant voice exercise will be prescribed to subjects following vocal loading.<br>Behavioral: Breathy voice<br>* A 4-hr breathy voice exercise will be prescribed to subjects following vocal loading.<br>Behavioral: Relaxation exercise<br>* A 4-hr relaxation exercise will be prescribed to subjects following vocal loading.<br>* Other names: meditation;Behavioral: Resonant voice and relaxation exercise<br>* A 4-hr resonant voice and relaxation exercise will be prescribed to subjects following vocal loading.<br>* Other names: Resonant voice and meditation exercise;|
| Sham Comparator: Controls<br> | Behavioral: voice rest<br>* A 4-hr voice rest will be prescribed to subjects following vocal loading.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarker levels in laryngeal secretion |  | up to 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute phonotrauma, computer modeling, resonant voice, breathy voice, voice rest, relaxation