Patients With and Without Phonotrauma

Defining Clinically Important Differences in Cepstral and Spectral Measures in Individuals 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.

Study Overview

• Status: Recruiting
• Conditions: Phonotrauma
• Intervention / Treatment: Diagnostic test: Acoustic voice analysis; Diagnostic test: High-speed videoendoscopy

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Laura Toles, PhD; Phone Number: 214-645-2943; Email: Laura.Toles@UTSouthwestern.edu
• Study Contact Backup: Name: Paula Arellano-Cruz; Phone Number: 214-648-8096; Email: paula.arellano-cruz@utsouthwestern.edu

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75235
      • Recruiting
      • UT Southwestern Medical Center
      • Contact: Laura Toles; Phone Number: 2146452943; Email: Laura.Toles@UTSouthwestern.edu
      • Contact: Paula Arellano-Cruz; Phone Number: 2146488096; Email: paula.arellano-cruz@utsouthwestern.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients (18-65 years of age) with a diagnosis of phonotrauma will be recruited from the laryngology clinics at UTSW Voice Center. All patients who are diagnosed with phonotraumatic vocal fold lesions (including vocal fold nodules, phonotraumatic polyps, mid-fold edema, and pseudocysts) will be referred for enrollment. Individuals without phonotrauma (18-65 years of age) will be recruited for the control group.

Description

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control Group- Without Phonotrauma; Videoendoscopy and acoustic recordings using a head-mounted microphone with a voice-specialized SLP for participants without voice disorders, acoustic recordings will involve the five repetitions of three vowels (/ɑ, i, u/) and a standard reading passage (Rainbow Passage) in three voice conditions (breathy, typical, and pressed). For all participants, high-speed videoendoscopy and simultaneous acoustic recording will occur on one repetition of a sustained /i/ in each requested condition.	Diagnostic test: Acoustic voice analysis; 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.
Patients Diagnosed with Phonotrauma; Videoendoscopy and acoustic recordings using a head-mounted microphone with a voice-specialized SLP for Participants who have a diagnosis of phonotrauma will be instructed to produce five repetitions of the same three vowels but in only two conditions: typical voice and "resonant" voice following stimulability assessment and with cues. They will be instructed to maintain relatively consistent volume and pitch across conditions. For all participants, high-speed videoendoscopy and simultaneous acoustic recording will occur on one repetition of a sustained /i/ in each requested condition.	Diagnostic test: High-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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cepstral Peak Prominence	Cepstral peak prominence is a measure of the periodic energy of the acoustic voice signal.	1 year
The difference between the first and second harmonic (H1-H2)	H1-H2 is a spectral measure derived from the acoustic voice signal that correlates with glottal configuration.	1 year
Average closing velocity	Vocal fold closing phase velocity averaged across 100 vibratory cycles	1 year

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD)

Publications and helpful links

General Publications

• Hillman RE, Stepp CE, Van Stan JH, Zanartu M, Mehta DD. An Updated Theoretical Framework for Vocal Hyperfunction. Am J Speech Lang Pathol. 2020 Nov 12;29(4):2254-2260. doi: 10.1044/2020_AJSLP-20-00104. Epub 2020 Oct 2.
• Verdolini K, Hess MM, Titze IR, Bierhals W, Gross M. Investigation of vocal fold impact stress in human subjects. J Voice. 1999 Jun;13(2):184-202. doi: 10.1016/s0892-1997(99)80022-8.
• Klatt DH, Klatt LC. Analysis, synthesis, and perception of voice quality variations among female and male talkers. J Acoust Soc Am. 1990 Feb;87(2):820-57. doi: 10.1121/1.398894.
• Awan SN, Roy N, Jette ME, Meltzner GS, Hillman RE. Quantifying dysphonia severity using a spectral/cepstral-based acoustic index: Comparisons with auditory-perceptual judgements from the CAPE-V. Clin Linguist Phon. 2010 Sep;24(9):742-58. doi: 10.3109/02699206.2010.492446.
• Murton O, Hillman R, Mehta D. Cepstral Peak Prominence Values for Clinical Voice Evaluation. Am J Speech Lang Pathol. 2020 Aug 4;29(3):1596-1607. doi: 10.1044/2020_AJSLP-20-00001. Epub 2020 Jul 13.
• Toles LE, Ortiz AJ, Marks KL, Burns JA, Hron T, Van Stan JH, Mehta DD, Hillman RE. Differences Between Female Singers With Phonotrauma and Vocally Healthy Matched Controls in Singing and Speaking Voice Use During 1 Week of Ambulatory Monitoring. Am J Speech Lang Pathol. 2021 Jan 27;30(1):199-209. doi: 10.1044/2020_AJSLP-20-00227. Epub 2021 Jan 20.

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2023
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: November 2, 2022
• First Submitted That Met QC Criteria: November 14, 2022
• First Posted (Actual): November 22, 2022

Study Record Updates

• Last Update Posted (Actual): July 30, 2025
• Last Update Submitted That Met QC Criteria: July 28, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: STU-2022-0655; R01DC015570 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No