Role of Exercise for Wound Healing in the Larynx

November 6, 2009 updated by: University of Pittsburgh
The purpose of this study is to explore quantitatively the hypothesis that "resonant voice," may enhance recovery from acute laryngeal phonotrauma, based on molecular assays from human laryngeal secretions and secondarily, clinical tests.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The objective is to use the following operationalized question: Does a voicing mode shown to correspond to high-amplitude, low impact vocal cord oscillations, "resonant voice," improve the amount and time-course of recovery from acute phonotrauma, compared to vocal rest or spontaneous speech, as measured with molecular assays (primarily) and with behavioral and clinical tests (secondarily)?

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15260
        • Univesity of Pittsburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 49 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • males and females who have had voice training and feel they are able to produce loud voice safely;
  • ages 18-49;
  • generally healthy;
  • normal hearing bilaterally at 20 dB to 8,000 Hz; and
  • demonstrated ability to produce "resonant voice" during training as determined by the examiner perceptually.

Exclusion Criteria:

  • current chronic voice problems;
  • current medications that are determined to possibly influence voice (e.g. diuretics, decongestants);
  • heightened gag reflex;
  • small nasal passage;
  • deviated septum; and
  • known or suspected allergy to anesthetics.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Voice rest
Behavioral: Voice rest
4-hr of complete refrain from any voice use
Experimental: Resonant voice exercise
Behavioral: Resonant voice
4-hr of resonant voice exercise
Experimental: Spontaneous speech
Behavioral: Spontaneous speech
Other Names:
  • 4-hr of conversational (normal) voice use

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Biomarkers in laryngeal secretions
Time Frame: Up to 24-hour post-baseline
Up to 24-hour post-baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Phonation Threshold Pressure (PTP)
Time Frame: Up to 24-hour post baseline
Up to 24-hour post baseline
Direct Magnitude Estimations of phonatory effort (DME)
Time Frame: Up to 24-hour post baseline
Up to 24-hour post baseline
Visual-perceptual ratings of the larynx
Time Frame: Up to 24-hour post baseline
Up to 24-hour post baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Investigators

  • Principal Investigator: Katherine Verdolini Abbott, Ph.D., University of Pittsburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Primary Completion (Actual)

March 1, 2005

Study Completion (Actual)

March 1, 2005

Study Registration Dates

First Submitted

November 5, 2009

First Submitted That Met QC Criteria

November 6, 2009

First Posted (Estimate)

November 9, 2009

Study Record Updates

Last Update Posted (Estimate)

November 9, 2009

Last Update Submitted That Met QC Criteria

November 6, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Other Study ID Numbers

  • DC005643

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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