Improving Voice Production for Adults With Age-related Dysphonia

Presbylarynx Clinical Trial

Official title:

Improving Voice Production for Adults With Age-related Dysphonia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03702322
• Other study ID #: R21DC016356
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: July 31, 2021

Study information

• Verified date: June 2019
• Source: University of Arizona
• Contact: Robin A Samlan, Ph.D.
• Phone: 520-621-8618
• Email: rsamlan[@]email.arizona.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objectives for this research are to determine the mechanisms by which specific therapy tasks improve voice in age-related dysphonia, and the conditions that limit the extent of improvement. The central hypothesis is that targeted therapy tasks will improve voice, and that severity will determine the extent of improvement.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: July 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Adults in age range who volunteer

• Can understand and complete directions presented in English

• People with voice disorder associated with advancing age will be included, including bowing, incomplete closure, mild edema, erythema, signs of laryngopharyngeal reflux.

Exclusion Criteria:

• Laryngeal differences not related to aging (e.g., vocal fold paralysis, moderate-severe edema, lesions, leukoplakia, dysplasia, Parkinson disease)

• Known history of stroke, brain injury, or other neurological disorder

Related Conditions & MeSH terms

• Age-Related Dysphonia
• Dysphonia
• Hoarseness
• Presbylarynx

Intervention

Behavioral:
• Voice therapy: respiratory
Abdominal voice onset
• Voice therapy: glottal closure
Pulling/pushing task
• Voice therapy: loud
Assertive task
• Voice therapy: Semiocclusion
Semi-occluded vocal tract

Locations

Country	Name	City	State
United States	Mayo Clinic	Scottsdale	Arizona
United States	University of Arizona	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
University of Arizona	Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative glottal gap from laryngeal high-speed videoendoscopy		End of year 3
Primary	Perceived voice quality	Participants will score the construct of "overall voice quality" using a technique called "sort and rate" in which listeners move icons representing each sound along a line. They align the icons so that best voices are on one side and worst voices are on the other. The distance between the icons represents how much better or worse one sound is than the other. There are no units to the scale. Rankings from all listeners are combined using the statistical technique of multidimensional scaling. The result is a ranked value for each sound file (i.e., voice production) that shows how different they are. There is no highest or lowest value.	End of year 3
Primary	Acoustic measure of voice quality (Cepstral Peak Prominence)		End of year 3
Secondary	Open quotient from laryngeal high-speed videoendoscopy		End of year 3
Secondary	Speed index from laryngeal high-speed videoendoscopy		End of year 3
Secondary	Maximum area declination ratefrom laryngeal high-speed videoendoscopy		End of year 3
Secondary	Fundamental frequency standard deviation from laryngeal high-speed videoendoscopy		End of year 3