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Role of Exercise for Wound Healing in the Larynx

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ClinicalTrials.gov Identifier: NCT01009632
Recruitment Status : Completed
First Posted : November 9, 2009
Last Update Posted : November 9, 2009
Sponsor:
Information provided by:
University of Pittsburgh

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acute Phonotrauma Behavioral: Resonant voice Behavioral: Voice rest Behavioral: Spontaneous speech Not Applicable

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  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Role of Exercise for Wound Healing in the Larynx
Study Start Date : February 2004
Actual Primary Completion Date : March 2005
Actual Study Completion Date : March 2005

Resource links provided by the National Library of Medicine


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 Name: 4-hr of conversational (normal) voice use




Primary Outcome Measures :
  1. Biomarkers in laryngeal secretions [ Time Frame: Up to 24-hour post-baseline ]

Secondary Outcome Measures :
  1. Phonation Threshold Pressure (PTP) [ Time Frame: Up to 24-hour post baseline ]
  2. Direct Magnitude Estimations of phonatory effort (DME) [ Time Frame: Up to 24-hour post baseline ]
  3. Visual-perceptual ratings of the larynx [ Time Frame: Up to 24-hour post baseline ]


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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01009632


Locations
United States, Pennsylvania
Univesity of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15260
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Katherine Verdolini Abbott, Ph.D. University of Pittsburgh

Responsible Party: Katherine Verdolini Abbott, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01009632     History of Changes
Other Study ID Numbers: DC005643
First Posted: November 9, 2009    Key Record Dates
Last Update Posted: November 9, 2009
Last Verified: November 2009