Hybrid Model of Vocal Inflammation and Tissue Mobilization

January 21, 2016 updated by: Kittie Verdolini Abbott, University of Pittsburgh
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15260
        • Univesity of Pittsburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: treatment
Behavioral: resonant voice
A 4-hr resonant voice exercise 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.
Other Names:
  • meditation
Behavioral: Resonant voice and relaxation exercise
A 4-hr resonant voice and relaxation exercise will be prescribed to subjects following vocal loading.
Other Names:
  • Resonant voice and meditation exercise
Sham Comparator: Controls
Behavioral: voice rest
A 4-hr voice rest will be prescribed to subjects following vocal loading.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Biomarker levels in laryngeal secretion
Time Frame: up to 2 months
up to 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

McGill University
National Institute on Deafness and Other Communication Disorders (NIDCD)
Purdue University

Investigators

  • Principal Investigator: Katherine Verdolini Abbott, Ph.D., University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

September 7, 2010

First Submitted That Met QC Criteria

September 7, 2010

First Posted (Estimate)

September 9, 2010

Study Record Updates

Last Update Posted (Estimate)

January 25, 2016

Last Update Submitted That Met QC Criteria

January 21, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DC008290
  • 5R01DC008290 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Phonotrauma

Clinical Trials on resonant voice

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sri Lanka

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe