Actively Recruiting

Age: 18Years - 65Years
All Genders
Healthy Volunteers
NCT05625191

Patients With and Without Phonotrauma

Led by University of Texas Southwestern Medical Center · Updated on 2025-07-30

100

Participants Needed

1

Research Sites

154 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

There is a substantial need to identify objective measures associated with hyperadduction of the vocal folds to recognize those at higher risk of developing phonotrauma so that risk mitigation strategies can be implemented before phonotrauma develops. The overall objective of this proposed project is to investigate the sensitivity and direction of change in cepstral peak prominence (CPP) and the magnitude difference between the first two harmonics of the voice spectrum (H1-H2) in response to varied phonation patterns, which will be addressed using the following two aims: Aim 1: Determine how CPP and H1-H2 change as a function of using pressed voice production in individuals without laryngeal pathology. Aim 2: Examine the sensitivity (minimally detectable change) and responsiveness (minimal clinically important difference) of CPP and H1-H2 to detect changes in different voice production conditions.

CONDITIONS

Official Title

Patients With and Without Phonotrauma

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 65 years
  • For control group: no history or current voice disorder
  • For control group: voice presentation within functional limits as determined by a voice specialist
  • For patient group: diagnosed with phonotrauma by a laryngologist (including vocal fold nodules, polyps, pseudocysts, or mid-fold edema)
Not Eligible

You will not qualify if you...

  • Atypical auditory-perceptual voice presentation
  • History of voice disorder or laryngeal surgery (control group)
  • Voice disorders unrelated to phonotrauma (patient group, e.g., vocal fold immobility, laryngeal dystonia, primary muscle tension dysphonia)
  • Previous voice therapy or laryngeal surgery (patient group)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

UT Southwestern Medical Center

Dallas, Texas, United States, 75235

Actively Recruiting

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Research Team

L

Laura Toles, PhD

CONTACT

P

Paula Arellano-Cruz

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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