Clinical trial NCT05625191: Patients With and Without Phonotrauma
Official title: Defining Clinically Important Differences in Cepstral and Spectral Measures in Individuals With and Without Phonotrauma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Phonotrauma
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2022-11-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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).

Primary outcomes:
measure: Cepstral Peak Prominence
timeFrame: 1 year
measure: The difference between the first and second harmonic (H1-H2)
timeFrame: 1 year
measure: Average closing velocity
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.