Patients With and Without Phonotrauma
ConditionPhonotrauma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorUniversity of Texas Southwestern Medical Center
About this trial
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
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
Atypical auditory-perceptual voice presentation
History of voice disorder or laryngeal surgery.
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
Trial 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.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
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).
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Control Group- Without Phonotrauma1 intervention
Group B: Patients Diagnosed with Phonotrauma1 intervention
Trial outcomes
Primary outcomes
1
Cepstral Peak Prominence
Cepstral peak prominence is a measure of the periodic energy of the acoustic voice signal.
Time frame
1 year2
The difference between the first and second harmonic (H1-H2)
H1-H2 is a spectral measure derived from the acoustic voice signal that correlates with glottal configuration.
Time frame
1 year3
Average closing velocity
Vocal fold closing phase velocity averaged across 100 vibratory cycles
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov