Patients With and Without Phonotrauma

Официальное название

Defining Clinically Important Differences in Cepstral and Spectral Measures in Individuals With and Without Phonotrauma

Обзор

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.

Вмешательства

• Диагностический тест 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 col
• Диагностический тест 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).

Первичные конечные точки

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

Критерии участия

Control Group:

Критерии включения

• 18-65 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).

Критерии исключения

• Atypical auditory-perceptual voice presentation
• History of voice disorder or laryngeal surgery.

Patient Group:

Критерии включения

• Diagnosed with phonotrauma (i.e., vocal fold nodules, vocal fold polyp, vocal fold pseudocyst, mid-fold edema) by a laryngologist.
• 18-65 years of age

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

США · 1 центр

• UT Southwestern Medical Center — Dallas

Публикации

• 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
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT05625191 · STU-2022-0655

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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