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Patients With and Without Phonotrauma

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05625191
Enrollment
100
Registered
2022-11-22
Start date
2023-01-17
Completion date
2026-12-31
Last updated
2026-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Phonotrauma

Brief summary

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.

Interventions

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.

DIAGNOSTIC_TESTHigh-speed videoendoscopy

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).

Sponsors

University of Texas Southwestern Medical Center
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

Control Group: Inclusion Criteria: 1. 18-65 years of age (to avoid confounding physiological factors related to puberty or presbyphonia) 2. No history of or current voice disorder 3. Auditory perceptual presentation globally within functional limits (as determined by a voice specialized SLP).

Exclusion criteria

1. Atypical auditory-perceptual voice presentation 2. History of voice disorder or laryngeal surgery. Patient Group: Inclusion Criteria: 1. Diagnosed with phonotrauma (i.e., vocal fold nodules, vocal fold polyp, vocal fold pseudocyst, mid-fold edema) by a laryngologist. 2. 18-65 years of age

Design outcomes

Primary

MeasureTime frameDescription
Cepstral Peak Prominence1 yearCepstral peak prominence is a measure of the periodic energy of the acoustic voice signal.
The difference between the first and second harmonic (H1-H2)1 yearH1-H2 is a spectral measure derived from the acoustic voice signal that correlates with glottal configuration.
Average closing velocity1 yearVocal fold closing phase velocity averaged across 100 vibratory cycles

Countries

United States

Contacts

CONTACTLaura Toles, PhD
Laura.Toles@UTSouthwestern.edu214-645-2943
CONTACTPaula Arellano-Cruz
paula.arellano-cruz@utsouthwestern.edu214-648-8096

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 12, 2026