Skip to content

Hybrid Model of Vocal Inflammation and Tissue Mobilization

Hybrid Model of Vocal Inflammation and Tissue Mobilization

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01197339
Enrollment
45
Registered
2010-09-09
Start date
2010-09-30
Completion date
2013-03-31
Last updated
2016-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Phonotrauma

Keywords

acute phonotrauma, computer modeling, resonant voice, breathy voice, voice rest, relaxation

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).

Interventions

BEHAVIORALBreathy voice

A 4-hr breathy voice exercise will be prescribed to subjects following vocal loading.

A 4-hr relaxation exercise will be prescribed to subjects following vocal loading.

BEHAVIORALresonant voice

A 4-hr resonant voice exercise will be prescribed to subjects following vocal loading.

BEHAVIORALvoice rest

A 4-hr voice rest will be prescribed to subjects following vocal loading.

BEHAVIORALResonant voice and relaxation exercise

A 4-hr resonant voice and relaxation exercise will be prescribed to subjects following vocal loading.

Sponsors

National Institute on Deafness and Other Communication Disorders (NIDCD)
CollaboratorNIH
McGill University
CollaboratorOTHER
Purdue University
CollaboratorOTHER
University of Pittsburgh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Biomarker levels in laryngeal secretionup to 2 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026