Improving Voice Production for Adults With Age-related Dysphonia

June 9, 2020 updated by: University of Arizona
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Recruiting
        • Mayo Clinic
        • Contact:
        • Contact:
          • David Lott, MD
          • Phone Number: 480-342-2983
      • Tucson, Arizona, United States, 85721

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Participants
All participants will undergo each treatment.
Behavioral: Voice therapy: respiratory
Abdominal voice onset
Behavioral: Voice therapy: glottal closure
Pulling/pushing task
Behavioral: Voice therapy: loud
Assertive task
Behavioral: Voice therapy: Semiocclusion
Semi-occluded vocal tract

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relative glottal gap from laryngeal high-speed videoendoscopy
Time Frame: End of year 3
End of year 3
Perceived voice quality
Time Frame: End of year 3
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
Acoustic measure of voice quality (Cepstral Peak Prominence)
Time Frame: End of year 3
End of year 3

Secondary Outcome Measures

Outcome Measure
Time Frame
Open quotient from laryngeal high-speed videoendoscopy
Time Frame: End of year 3
End of year 3
Speed index from laryngeal high-speed videoendoscopy
Time Frame: End of year 3
End of year 3
Maximum area declination ratefrom laryngeal high-speed videoendoscopy
Time Frame: End of year 3
End of year 3
Fundamental frequency standard deviation from laryngeal high-speed videoendoscopy
Time Frame: End of year 3
End of year 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arizona

Collaborators

Mayo Clinic

Investigators

  • Principal Investigator: Robin A Samlan, Ph.D., University of Arizona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2019

Primary Completion (Anticipated)

July 31, 2021

Study Completion (Anticipated)

July 31, 2021

Study Registration Dates

First Submitted

September 17, 2018

First Submitted That Met QC Criteria

October 9, 2018

First Posted (Actual)

October 11, 2018

Study Record Updates

Last Update Posted (Actual)

June 11, 2020

Last Update Submitted That Met QC Criteria

June 9, 2020

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R21DC016356 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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