NCT05625191

Patients With and Without Phonotrauma

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	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.
DIAGNOSTIC_TEST	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).

Timeline

• Start date: 2023-01-17
• Primary completion: 2025-12-30
• Completion: 2025-12-30
• First posted: 2022-11-22
• Last updated: 2025-07-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study