Patients With and Without Phonotrauma
Part of paid clinical trials in Dallas, Texas.
- Sponsor
- University of Texas Southwestern Medical Center
- Study ID
- NCT05625191
- Status
- Recruiting
Conditions
- Phonotrauma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Accepted
Interventions
- Acoustic voice analysis — DIAGNOSTIC_TESTAcoustic 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 — DIAGNOSTIC_TESTHigh-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).
Study Details
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.
Key Dates
- Start date
- Jan 17, 2023
- Status verified
- Jun 2026
- Primary completion
- Dec 31, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 100 participants (estimated)
Arms
- Arm: Control Group- Without PhonotraumaVideoendoscopy 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.
- Arm: Patients Diagnosed with PhonotraumaVideoendoscopy 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.
Primary Outcome Measure
Cepstral Peak Prominence [ Time Frame: 1 year ]
Central Contacts
- Laura Toles, PhD214-645-2943
- Paula Arellano-Cruz214-648-8096
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| UT Southwestern Medical Center | Dallas | Texas | 75235 |