Clinical trial NCT01197339: Hybrid Model of Vocal Inflammation and Tissue Mobilization
Official title: Hybrid Model of Vocal Inflammation and Tissue Mobilization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acute Phonotrauma
Keywords: acute phonotrauma
computer modeling
resonant voice
breathy voice
voice rest
relaxation
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
name: McGill University
name: Purdue University
First posted: 2010-09-09
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

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).


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

Primary outcomes:
measure: Biomarker levels in laryngeal secretion
timeFrame: up to 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Univesity of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Katherine Verdolini Abbott, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.