Recruiting

Observational Study

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT05625191

Conditions

Phonotrauma

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Acoustic voice analysis

High-speed videoendoscopy

Study Details

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

Study ID

NCT05625191

Start date

Jan 17, 2023

Status verified date

Jun, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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 Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

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).

Primary outcome measure

  • Cepstral Peak Prominence [ Time Frame: 1 year ]
  • The difference between the first and second harmonic (H1-H2) [ Time Frame: 1 year ]
  • Average closing velocity [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Laura Toles, PhD

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

Paula Arellano-Cruz

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

Locations

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75235

Contacts

Laura Toles

2146452943Laura.Toles@UTSouthwestern.edu

Paula Arellano-Cruz

2146488096paula.arellano-cruz@utsouthwestern.edu

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Jun 11, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2026-06-11.