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Patients With and Without Phonotrauma

The University of Texas System (UT) logo

The University of Texas System (UT)

Status

Enrolling

Conditions

Phonotrauma

Treatments

Diagnostic Test: High-speed videoendoscopy
Diagnostic Test: Acoustic voice analysis

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT05625191
STU-2022-0655

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

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).

Trial design

100 participants in 2 patient groups

Control Group- Without Phonotrauma
Description:
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.
Treatment:
Diagnostic Test: Acoustic voice analysis
Patients Diagnosed with Phonotrauma
Description:
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.
Treatment:
Diagnostic Test: High-speed videoendoscopy

Trial contacts and locations

1

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Central trial contact

Paula Arellano-Cruz; Laura Toles, PhD

Data sourced from clinicaltrials.gov

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