Hybrid Model of Vocal Inflammation and Tissue Mobilization

NCT01197339 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2016-01-25

No results posted yet for this study

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).

Conditions

  • Acute Phonotrauma

Interventions

BEHAVIORAL

resonant voice

A 4-hr resonant voice exercise will be prescribed to subjects following vocal loading.

BEHAVIORAL

voice rest

A 4-hr voice rest will be prescribed to subjects following vocal loading.

BEHAVIORAL

Breathy voice

A 4-hr breathy voice exercise will be prescribed to subjects following vocal loading.

BEHAVIORAL

Relaxation exercise

A 4-hr relaxation exercise will be prescribed to subjects following vocal loading.

BEHAVIORAL

Resonant voice and relaxation exercise

A 4-hr resonant voice and relaxation exercise will be prescribed to subjects following vocal loading.

Sponsors & Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

    collaborator NIH
  • McGill University

    collaborator OTHER
  • Purdue University

    collaborator OTHER
  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Katherine Verdolini Abbott, Ph.D. · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01197339 on ClinicalTrials.gov