NCT01197339

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2010

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

September 7, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 9, 2010

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

January 25, 2016

Status Verified

January 1, 2016

Enrollment Period

2.5 years

First QC Date

September 7, 2010

Last Update Submit

January 21, 2016

Conditions

Acute Phonotrauma

Keywords

acute phonotraumacomputer modelingresonant voicebreathy voicevoice restrelaxation

Outcome Measures

Primary Outcomes (1)

  • Biomarker levels in laryngeal secretion

    up to 2 months

Study Arms (2)

treatment

EXPERIMENTAL
Behavioral: resonant voiceBehavioral: Breathy voiceBehavioral: Relaxation exerciseBehavioral: Resonant voice and relaxation exercise

Controls

SHAM COMPARATOR
Behavioral: voice rest

Interventions

resonant voiceBEHAVIORAL

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

treatment
voice restBEHAVIORAL

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

Controls
Breathy voiceBEHAVIORAL

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

treatment
Relaxation exerciseBEHAVIORAL

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

Also known as: meditation
treatment
Resonant voice and relaxation exerciseBEHAVIORAL

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

Also known as: Resonant voice and meditation exercise
treatment

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univesity of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

Related Publications (1)

  • 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.

    PMID: 20025041RESULT

MeSH Terms

Interventions

Meditation

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesRelaxation TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Katherine Verdolini Abbott, Ph.D.

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 7, 2010

First Posted

September 9, 2010

Study Start

September 1, 2010

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

January 25, 2016

Record last verified: 2016-01

Locations

US(1)