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OpenTrials
Completed

NCT Number: NCT01009632

Role of Exercise for Wound Healing in the Larynx

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.

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Key information

Conditions

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Univesity of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

About this study

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)?

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Resonant voice

Behavioral

4-hr of resonant voice exercise

Voice rest

Behavioral

4-hr of complete refrain from any voice use

Spontaneous speech

Behavioral

Other names: 4-hr of conversational (normal) voice use

Primary outcomes

  1. Biomarkers in laryngeal secretions

    Time frame: Up to 24-hour post-baseline

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Nov 9, 2009
Registry last updated
Nov 9, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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