Hybrid Model of Vocal Inflammation and Tissue Mobilization

Phase 1

Completed

• Conditions: Acute Phonotrauma
• Interventions: Behavioral: voice rest; Behavioral: resonant voice; Behavioral: Breathy voice; Behavioral: Relaxation exercise; Behavioral: Resonant voice and relaxation exercise

• Registration Number: NCT01197339
• Lead Sponsor: University of Pittsburgh

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-07
• Study First Submitted QC: 2010-09-07
• Study First Posted: 2010-09-09
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-21
• Last Update Posted: 2016-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 45

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Controls	voice rest	-
treatment	Relaxation exercise	-
treatment	resonant voice	-
treatment	Breathy voice	-
treatment	Resonant voice and relaxation exercise	-

Primary Outcome Measures

Name	Time	Method
Biomarker levels in laryngeal secretion	up to 2 months

Trial Locations

Locations (1)

Univesity of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States