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NCT Number: NCT05625191

Patients With and Without Phonotrauma

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.

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Key information

Conditions

Phonotrauma

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

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

Control Group:

Inclusion criteria

  • 18-65 years of age (to avoid confounding physiological factors related to puberty or presbyphonia)
  • No history of or current voice disorder
  • Auditory perceptual presentation globally within functional limits (as determined by a voice specialized SLP).

Exclusion criteria

  • Atypical auditory-perceptual voice presentation
  • History of voice disorder or laryngeal surgery.

Patient Group:

Inclusion criteria

  • Diagnosed with phonotrauma (i.e., vocal fold nodules, vocal fold polyp, vocal fold pseudocyst, mid-fold edema) by a laryngologist.
  • 18-65 years of age

Exclusion criteria

  • Diagnosis of voice disorder not related to phonotrauma (e.g., vocal fold immobility, laryngeal dystonia, primary muscle tension dysphonia, etc.)
  • Previous history of laryngeal surgery or voice therapy (to avoid confounding effects of previous treatment).

Treatment and study plan

Acoustic voice analysis

Diagnostic Test

Acoustic recordings will involve the five repetitions of three vowels (/ɑ, i, u/) and a standard reading passage (Rainbow Passage) in different voice conditions. Control participants will produce voice in breathy, typical, and pressed conditions. Patient participants will produce voice in typical production and in a resonant voice production. High-speed videoendoscopy and simultaneous acoustic recording will occur on one repetition of a sustained /i/ in each requested condition. Data will be collected using a head-mounted microphone.

High-speed videoendoscopy

Diagnostic Test

High-speed videoendoscopy will occur on one repetition of a sustained /i/ in each requested condition. Exams will be recorded using the Phantom V311 high-speed camera (Vision Research, Wayne, NJ) connected to a Storz 70° rigid laryngoscope using a 400 Watt Xenon light source (Titan 400E).

Primary outcomes

  1. Cepstral Peak Prominence

    Time frame: 1 year

    Cepstral peak prominence is a measure of the periodic energy of the acoustic voice signal.

  2. The difference between the first and second harmonic (H1-H2)

    Time frame: 1 year

    H1-H2 is a spectral measure derived from the acoustic voice signal that correlates with glottal configuration.

  3. Average closing velocity

    Time frame: 1 year

    Vocal fold closing phase velocity averaged across 100 vibratory cycles

Study contacts

Contact information is provided by the study sponsor or research team.

Laura Toles, PhD

CONTACT

[email protected]

214-645-2943

Paula Arellano-Cruz

CONTACT

[email protected]

214-648-8096

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

Defining Clinically Important Differences in Cepstral and Spectral Measures in Individuals With and Without Phonotrauma

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Nov 22, 2022
Registry last updated
Jun 11, 2026

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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