NCT03702322

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Apr 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress92%
Apr 2019Dec 2026

First Submitted

Initial submission to the registry

September 17, 2018

Completed
24 days until next milestone

First Posted

Study publicly available on registry

October 11, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

October 10, 2025

Status Verified

October 1, 2025

Enrollment Period

7.8 years

First QC Date

September 17, 2018

Last Update Submit

October 8, 2025

Conditions

PresbylarynxAge-Related Dysphonia

Outcome Measures

Primary Outcomes (3)

  • Relative glottal gap from laryngeal high-speed videoendoscopy

    End of year 3

  • 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

  • Acoustic measure of voice quality (Cepstral Peak Prominence)

    End of year 3

Secondary Outcomes (4)

  • Open quotient from laryngeal high-speed videoendoscopy

    End of year 3

  • Speed index from laryngeal high-speed videoendoscopy

    End of year 3

  • Maximum area declination ratefrom laryngeal high-speed videoendoscopy

    End of year 3

  • Fundamental frequency standard deviation from laryngeal high-speed videoendoscopy

    End of year 3

Study Arms (1)

Participants

OTHER

All participants will undergo each treatment.

Behavioral: Voice therapy: respiratoryBehavioral: Voice therapy: glottal closureBehavioral: Voice therapy: loudBehavioral: Voice therapy: Semiocclusion

Interventions

Voice therapy: respiratoryBEHAVIORAL

Abdominal voice onset

Participants
Voice therapy: glottal closureBEHAVIORAL

Pulling/pushing task

Participants
Voice therapy: loudBEHAVIORAL

Assertive task

Participants
Voice therapy: SemiocclusionBEHAVIORAL

Semi-occluded vocal tract

Participants

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mayo Clinic

Scottsdale, Arizona, 85259, United States

Location

University of Arizona

Tucson, Arizona, 85721, United States

Location

Study Officials

  • Robin A Samlan, Ph.D.

    University of Arizona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Participants in the perceptual studies rating audio and visual files will be masked.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: All participants receive every intervention in randomized order
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2018

First Posted

October 11, 2018

Study Start

April 1, 2019

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

October 10, 2025

Record last verified: 2025-10

Locations

US(2)