Improving Voice Production for Adults With Age-related Dysphonia
Primary Purpose
Presbylarynx, Age-Related Dysphonia
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Voice therapy: respiratory
Voice therapy: glottal closure
Voice therapy: loud
Voice therapy: Semiocclusion
Sponsored by
About this trial
This is an interventional treatment trial for Presbylarynx
Eligibility Criteria
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
Sites / Locations
- Mayo ClinicRecruiting
- University of ArizonaRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Participants
Arm Description
All participants will undergo each treatment.
Outcomes
Primary Outcome Measures
Relative glottal gap from laryngeal high-speed videoendoscopy
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.
Acoustic measure of voice quality (Cepstral Peak Prominence)
Secondary Outcome Measures
Open quotient from laryngeal high-speed videoendoscopy
Speed index from laryngeal high-speed videoendoscopy
Maximum area declination ratefrom laryngeal high-speed videoendoscopy
Fundamental frequency standard deviation from laryngeal high-speed videoendoscopy
Full Information
NCT ID
NCT03702322
First Posted
September 17, 2018
Last Updated
June 9, 2020
Sponsor
University of Arizona
Collaborators
Mayo Clinic
1. Study Identification
Unique Protocol Identification Number
NCT03702322
Brief Title
Improving Voice Production for Adults With Age-related Dysphonia
Official Title
Improving Voice Production for Adults With Age-related Dysphonia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
July 31, 2021 (Anticipated)
Study Completion Date
July 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arizona
Collaborators
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbylarynx, Age-Related Dysphonia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All participants receive every intervention in randomized order
Masking
None (Open Label)
Masking Description
Participants in the perceptual studies rating audio and visual files will be masked.
Allocation
N/A
Enrollment
220 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Participants
Arm Type
Other
Arm Description
All participants will undergo each treatment.
Intervention Type
Behavioral
Intervention Name(s)
Voice therapy: respiratory
Intervention Description
Abdominal voice onset
Intervention Type
Behavioral
Intervention Name(s)
Voice therapy: glottal closure
Intervention Description
Pulling/pushing task
Intervention Type
Behavioral
Intervention Name(s)
Voice therapy: loud
Intervention Description
Assertive task
Intervention Type
Behavioral
Intervention Name(s)
Voice therapy: Semiocclusion
Intervention Description
Semi-occluded vocal tract
Primary Outcome Measure Information:
Title
Relative glottal gap from laryngeal high-speed videoendoscopy
Time Frame
End of year 3
Title
Perceived voice quality
Description
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.
Time Frame
End of year 3
Title
Acoustic measure of voice quality (Cepstral Peak Prominence)
Time Frame
End of year 3
Secondary Outcome Measure Information:
Title
Open quotient from laryngeal high-speed videoendoscopy
Time Frame
End of year 3
Title
Speed index from laryngeal high-speed videoendoscopy
Time Frame
End of year 3
Title
Maximum area declination ratefrom laryngeal high-speed videoendoscopy
Time Frame
End of year 3
Title
Fundamental frequency standard deviation from laryngeal high-speed videoendoscopy
Time Frame
End of year 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robin A Samlan, Ph.D.
Phone
520-621-8618
Email
rsamlan@email.arizona.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Natalie Monahan, M.S.
Phone
520-621-4655
Email
nmonahan@email.arizona.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robin A Samlan, Ph.D.
Organizational Affiliation
University of Arizona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie C Zacharias, PhD
Phone
480-301-4932
Email
zacharias.stephanie@mayo.edu
First Name & Middle Initial & Last Name & Degree
David Lott, MD
Phone
480-342-2983
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85721
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robin A Samlan, PhD
Phone
520-621-8618
Email
rsamlan@email.arizona.edu
12. IPD Sharing Statement
Learn more about this trial
Improving Voice Production for Adults With Age-related Dysphonia
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