Hybrid Model of Vocal Inflammation and Tissue Mobilization
Primary Purpose
Acute Phonotrauma
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
resonant voice
voice rest
Breathy voice
Relaxation exercise
Resonant voice and relaxation exercise
Sponsored by

About this trial
This is an interventional basic science trial for Acute Phonotrauma focused on measuring acute phonotrauma, computer modeling, resonant voice, breathy voice, voice rest, relaxation
Eligibility Criteria
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
Sites / Locations
- Univesity of Pittsburgh
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
treatment
Controls
Arm Description
Outcomes
Primary Outcome Measures
Biomarker levels in laryngeal secretion
Secondary Outcome Measures
Full Information
NCT ID
NCT01197339
First Posted
September 7, 2010
Last Updated
January 21, 2016
Sponsor
University of Pittsburgh
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD), McGill University, Purdue University
1. Study Identification
Unique Protocol Identification Number
NCT01197339
Brief Title
Hybrid Model of Vocal Inflammation and Tissue Mobilization
Official Title
Hybrid Model of Vocal Inflammation and Tissue Mobilization
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD), McGill University, Purdue University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Phonotrauma
Keywords
acute phonotrauma, computer modeling, resonant voice, breathy voice, voice rest, relaxation
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
treatment
Arm Type
Experimental
Arm Title
Controls
Arm Type
Sham Comparator
Intervention Type
Behavioral
Intervention Name(s)
resonant voice
Intervention Description
A 4-hr resonant voice exercise will be prescribed to subjects following vocal loading.
Intervention Type
Behavioral
Intervention Name(s)
voice rest
Intervention Description
A 4-hr voice rest will be prescribed to subjects following vocal loading.
Intervention Type
Behavioral
Intervention Name(s)
Breathy voice
Intervention Description
A 4-hr breathy voice exercise will be prescribed to subjects following vocal loading.
Intervention Type
Behavioral
Intervention Name(s)
Relaxation exercise
Other Intervention Name(s)
meditation
Intervention Description
A 4-hr relaxation exercise will be prescribed to subjects following vocal loading.
Intervention Type
Behavioral
Intervention Name(s)
Resonant voice and relaxation exercise
Other Intervention Name(s)
Resonant voice and meditation exercise
Intervention Description
A 4-hr resonant voice and relaxation exercise will be prescribed to subjects following vocal loading.
Primary Outcome Measure Information:
Title
Biomarker levels in laryngeal secretion
Time Frame
up to 2 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine Verdolini Abbott, Ph.D.
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Univesity of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15260
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20025041
Citation
Li NY, Abbott KV, Rosen C, An G, Hebda PA, Vodovotz Y. Translational systems biology and voice pathophysiology. Laryngoscope. 2010 Mar;120(3):511-5. doi: 10.1002/lary.20755.
Results Reference
result
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Hybrid Model of Vocal Inflammation and Tissue Mobilization
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