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Hybrid Model of Vocal Inflammation and Tissue Mobilization

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01197339
First Posted: September 9, 2010
Last Update Posted: January 25, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institute on Deafness and Other Communication Disorders (NIDCD)
McGill University
Purdue University
Information provided by (Responsible Party):
Kittie Verdolini Abbott, University of Pittsburgh
  Purpose
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).

Condition Intervention Phase
Acute Phonotrauma Behavioral: resonant voice Behavioral: voice rest Behavioral: Breathy voice Behavioral: Relaxation exercise Behavioral: Resonant voice and relaxation exercise Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Hybrid Model of Vocal Inflammation and Tissue Mobilization

Further study details as provided by Kittie Verdolini Abbott, University of Pittsburgh:

Primary Outcome Measures:
  • Biomarker levels in laryngeal secretion [ Time Frame: up to 2 months ]

Enrollment: 45
Study Start Date: September 2010
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: meditation
Behavioral: Resonant voice and relaxation exercise
A 4-hr resonant voice and relaxation exercise will be prescribed to subjects following vocal loading.
Other Name: Resonant voice and meditation exercise
Sham Comparator: Controls Behavioral: voice rest
A 4-hr voice rest will be prescribed to subjects following vocal loading.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01197339


Locations
United States, Pennsylvania
Univesity of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15260
Sponsors and Collaborators
University of Pittsburgh
National Institute on Deafness and Other Communication Disorders (NIDCD)
McGill University
Purdue University
Investigators
Principal Investigator: Katherine Verdolini Abbott, Ph.D. University of Pittsburgh
  More Information

Publications:
Responsible Party: Kittie Verdolini Abbott, Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01197339     History of Changes
Other Study ID Numbers: DC008290
5R01DC008290 ( U.S. NIH Grant/Contract )
First Submitted: September 7, 2010
First Posted: September 9, 2010
Last Update Posted: January 25, 2016
Last Verified: January 2016

Keywords provided by Kittie Verdolini Abbott, University of Pittsburgh:
acute phonotrauma
computer modeling
resonant voice
breathy voice
voice rest
relaxation

Additional relevant MeSH terms:
Inflammation
Pathologic Processes