Hybrid Model of Vocal Inflammation and Tissue Mobilization

University of Pittsburgh

Status and phase: Completed; Phase 1

Conditions: Acute Phonotrauma

Treatments: Behavioral: Resonant voice and relaxation exercise; Behavioral: resonant voice; Behavioral: Breathy voice; Behavioral: voice rest; Behavioral: Relaxation exercise

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01197339

DC008290

5R01DC008290 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Enrollment: 45 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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45 participants in 2 patient groups

treatment

Experimental group

Treatment:

Behavioral: Relaxation exercise

Behavioral: Breathy voice

Behavioral: resonant voice

Behavioral: Resonant voice and relaxation exercise

Controls

Sham Comparator group

Treatment:

Behavioral: voice rest