Ignite Creation Date:
2024-05-06 @ 6:19 PM
Last Modification Date:
2024-10-26 @ 2:46 PM
Study NCT ID:
NCT05625191
Status:
RECRUITING
Last Update Posted:
2024-01-12
First Post:
2022-11-02
Brief Title:
Patients with and Without Phonotrauma
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
Defining Clinically Important Differences in Cepstral and Spectral Measures in Individuals with and Without Phonotrauma
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None