Hybrid Model of Vocal Inflammation and Tissue Mobilization

NCT ID: NCT01197339

Last Updated: 2016-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2013-03-31

Brief Summary

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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).

Detailed Description

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Conditions

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Acute Phonotrauma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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treatment

Group Type EXPERIMENTAL

resonant voice

Intervention Type BEHAVIORAL

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

Breathy voice

Intervention Type BEHAVIORAL

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

Relaxation exercise

Intervention Type BEHAVIORAL

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

Resonant voice and relaxation exercise

Intervention Type BEHAVIORAL

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

Controls

Group Type SHAM_COMPARATOR

voice rest

Intervention Type BEHAVIORAL

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

Interventions

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resonant voice

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

Intervention Type BEHAVIORAL

voice rest

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

Intervention Type BEHAVIORAL

Breathy voice

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

Intervention Type BEHAVIORAL

Relaxation exercise

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

Intervention Type BEHAVIORAL

Resonant voice and relaxation exercise

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

Intervention Type BEHAVIORAL

Other Intervention Names

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meditation Resonant voice and meditation exercise

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role collaborator

McGill University

OTHER

Sponsor Role collaborator

Purdue University

OTHER

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Kittie Verdolini Abbott

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Katherine Verdolini Abbott, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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Univesity of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 20025041 (View on PubMed)

Other Identifiers

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5R01DC008290

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DC008290

Identifier Type: -

Identifier Source: org_study_id

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