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

September 7, 2010
February 5, 2013
September 2010
March 2013   (final data collection date for primary outcome measure)
Biomarker levels in laryngeal secretion [ Time Frame: up to 2 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01197339 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Hybrid Model of Vocal Inflammation and Tissue Mobilization
Hybrid Model of Vocal Inflammation and Tissue Mobilization

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).

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Basic Science
Acute Phonotrauma
  • Behavioral: resonant voice
    A 4-hr resonant voice exercise will be prescribed to subjects following vocal loading.
    Other Name: resonant voice
  • Behavioral: voice rest
    A 4-hr voice rest will be prescribed to subjects following vocal loading.
    Other Name: voice rest
  • 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
  • Experimental: treatment
    Interventions:
    • Behavioral: resonant voice
    • Behavioral: Breathy voice
    • Behavioral: Relaxation exercise
    • Behavioral: Resonant voice and relaxation exercise
  • Sham Comparator: Controls
    Intervention: Behavioral: voice rest
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. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
45
March 2013
March 2013   (final data collection date for primary outcome measure)

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
Female
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01197339
DC008290, 5R01DC008290
No
Katherine Verdolini Abbott, University of Pittsburgh
University of Pittsburgh
  • National Institute on Deafness and Other Communication Disorders (NIDCD)
  • McGill University
  • Purdue University
Principal Investigator: Katherine Verdolini Abbott, Ph.D. University of Pittsburgh
University of Pittsburgh
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP