Hybrid Model of Vocal Inflammation and Tissue Mobilization

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
McGill University
Purdue University
Information provided by (Responsible Party):
Katherine Verdolini Abbott, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01197339
First received: September 7, 2010
Last updated: February 5, 2013
Last verified: February 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Hybrid Model of Vocal Inflammation and Tissue Mobilization

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Biomarker levels in laryngeal secretion [ Time Frame: up to 2 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 45
Study Start Date: September 2010
Estimated Study Completion Date: March 2013
Estimated 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.
Other Name: resonant voice
Behavioral: Breathy voice
A 4-hr breathy voice exercise will be prescribed to subjects following vocal loading.
Other Name: Breathy voice
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.
Other Name: voice rest

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01197339

Locations
United States, Pennsylvania
Univesity of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15260
Sponsors and Collaborators
University of Pittsburgh
McGill University
Purdue University
Investigators
Principal Investigator: Katherine Verdolini Abbott, Ph.D. University of Pittsburgh
  More Information

Publications:
Responsible Party: Katherine Verdolini Abbott, Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01197339     History of Changes
Other Study ID Numbers: DC008290, 5R01DC008290
Study First Received: September 7, 2010
Last Updated: February 5, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on October 21, 2014