Patients With and Without Phonotrauma

NCT05625191 | Recruiting DMC FDA Device

• 1 other identifier: STU-2022-0655
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Phonotrauma

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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

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

Interventions

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.

Control Group- Without Phonotrauma

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).

Patients Diagnosed with Phonotrauma

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75235, United States

RECRUITING

Related Publications (6)

• 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.

  PMID: 33007164 BACKGROUND

• 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.

  PMID: 10442749 BACKGROUND

• 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.

  PMID: 2137837 BACKGROUND

• 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.

  PMID: 20687828 BACKGROUND

• 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.

  PMID: 32658592 BACKGROUND

• 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.

  PMID: 33472007 BACKGROUND

Central Study Contacts

Laura Toles, PhD

CONTACT

214-645-2943; Laura.Toles@UTSouthwestern.edu

Paula Arellano-Cruz

CONTACT

214-648-8096; paula.arellano-cruz@utsouthwestern.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 2, 2022
• First Posted: November 22, 2022
• Study Start: January 17, 2023
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: July 30, 2025

Record last verified: 2025-07

Locations

US (1)