Skip to main content
OpenTrials
Completed

NCT Number: NCT01197339

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Univesity of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resonant voice

Behavioral

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

Voice rest

Behavioral

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

Breathy voice

Behavioral

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

Relaxation Exercise

Behavioral

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

Other names: meditation

Resonant voice and relaxation exercise

Behavioral

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

Other names: Resonant voice and meditation exercise

Primary outcomes

  1. Biomarker levels in laryngeal secretion

    Time frame: up to 2 months

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • McGill University
  • National Institute on Deafness and Other Communication Disorders (NIDCD)
  • Purdue University

Registry information

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Sep 9, 2010
Registry last updated
Jan 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.