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Role of Exercise for Wound Healing in the Larynx

This study has been completed.
Sponsor:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01009632
First received: November 5, 2009
Last updated: November 6, 2009
Last verified: November 2009
  Purpose

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 Intervention
Acute Phonotrauma
Behavioral: Resonant voice
Behavioral: Voice rest
Behavioral: Spontaneous speech

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Role of Exercise for Wound Healing in the Larynx

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Biomarkers in laryngeal secretions [ Time Frame: Up to 24-hour post-baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Phonation Threshold Pressure (PTP) [ Time Frame: Up to 24-hour post baseline ] [ Designated as safety issue: No ]
  • Direct Magnitude Estimations of phonatory effort (DME) [ Time Frame: Up to 24-hour post baseline ] [ Designated as safety issue: No ]
  • Visual-perceptual ratings of the larynx [ Time Frame: Up to 24-hour post baseline ] [ Designated as safety issue: No ]

Enrollment: 9
Study Start Date: February 2004
Study Completion Date: March 2005
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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)?

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Katherine Verdolini Abbott, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01009632     History of Changes
Other Study ID Numbers: DC005643
Study First Received: November 5, 2009
Last Updated: November 6, 2009
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on November 25, 2014