NCT03015870

Brief Summary

Many detrimental effects of aging have been identified in the human voice, most of which are accepted as "normal". However, age-related vocal deficits disrupt communication and decrease quality of life in older adults and may be preventable and/or treatable through behavioral interventions. The objective of this proposal is to determine the effectiveness of a technology-assisted vocal exercise intervention on the vocal function and quality of life in older adults. Forty older adults (65+) will be recruited and randomly assigned to either an app or PDF-delivered vocal training intervention lasting 8 weeks. Pre- and post-testing involving vocal functioning assessments, as well as mobility, psychosocial, and cognitive functioning assessments will be conducted. This interdisciplinary project will enhance the investigators understanding of physical, mental, and social health-related quality of life among older adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

September 1, 2014

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 4, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 10, 2017

Completed
Last Updated

January 10, 2017

Status Verified

January 1, 2017

Enrollment Period

2.3 years

First QC Date

November 4, 2015

Last Update Submit

January 6, 2017

Conditions

Keywords

vocal dysfunctionvoicevocal foldsvocal aging

Outcome Measures

Primary Outcomes (2)

  • Vocal acoustic function

    Dysphonia Severity Index: composite measure of maximum phonation time (s), highest fundamental frequency (Hz), lowest intensity (dB) and jitter (%).

    8-week change from baseline

  • Vocal aerodynamic function

    Phonation threshold pressure (kPa)

    8-week change from baseline

Secondary Outcomes (4)

  • Program engagement and app usability

    8-week training period

  • Training-induced Change in Voice-related Quality of Life

    8-week change from baseline

  • Acceptability/feasibility of intervention

    Post-intervention (8-week follow-up)

  • Respiratory Function

    8-week change from baseline

Study Arms (2)

Feedback

EXPERIMENTAL

Behavioral: Vocal exercise with real-time feedback.

Behavioral: Vocal exercise with real-time feedback

Recording

ACTIVE COMPARATOR

Behavioral: Vocal exercise with recording

Behavioral: Vocal exercise with recording

Interventions

The feedback intervention will use iPads pre-installed with a PDF of vocal exercises for the full duration of the study and with an app which will provide tailored feedback regarding pitch, loudness, and duration of phonation during practice sessions.

Feedback

The recording intervention will use an iPad pre-installed with the PDF of vocal exercises for the full duration of the study, but no feedback app.Participants audio record self while performing vocal exercises

Recording

Eligibility Criteria

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

You may qualify if:

  • Age 65 years or older
  • Vision at least 20/40 with glass or contacts

You may not qualify if:

  • Moderate-severe cognitive impairment
  • Currently engaged in regular daily singing practice
  • Currently involved in a research study involving exercise, memory, or vocal strengthening
  • Currently being treated for a voice disorder by either an ENT or SLP

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois at Urbana-Champaign

Champaign, Illinois, 61820, United States

Location

Study Officials

  • Aaron M Johnson, PhD

    University of Illinois at Urbana-Champaign

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2015

First Posted

January 10, 2017

Study Start

September 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

January 10, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will share

Primary data will be made available via https://databank.illinois.edu/ within 6 months of trial completion. Secondary data will be available within 2 years of trial completion.

Locations