Technology-assisted Vocal Exercise for Older Adults

Aging Clinical Trial

Official title:

Technology-assisted Vocal Exercise for Older Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03015870
• Other study ID #: IRB15130
• Status: Completed
• Phase: N/A
• First received: November 4, 2015
• Last updated: January 6, 2017
• Start date: September 2014
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: University of Illinois at Urbana-Champaign
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

All participants will receive an iPad pre-loaded with an instructional PDF containing written instructions and embedded recorded audio prompts to assist with the delivery of an established vocal training paradigm, the Vocal Function Exercises (VFE) developed by Stemple.22 The VFE involves a set of four exercises focusing on extending maximum phonation time, increasing pitch range, and, therefore, improving coordination of the respiratory, phonatory, and resonatory systems during voicing. The iPads will be collected from the participants at the conclusion of the study at the post-intervention testing sessions.

Participants will be randomly assigned to either an experimental feedback group or active control no feedback group. Participants in the feedback group will receive iPads pre-loaded with Sonneta Voice Monitor app (MintLeaf Software) which will provide tailored feedback regarding pitch, loudness, and duration of phonation during practice sessions. The no feedback group will be provided with an iPad pre-installed with the PDF for the full duration of the study, but no feedback app.

Prior to and separate from the individual baseline testing appointments (described below), one group-based introductory session will be held to orient all participants to iPad controls (i.e., navigation, volume, recordings), as well as training specific to their assigned condition (how to use the pdf or app). Participants will complete a progressive weekly training schedule (3, 4, 5, 6, 7, 7, 7, & 7 days per week) 2x per day for 30-minute sessions over 8 weeks. The first training session will be monitored to provide technical assistance and ensure fidelity of the training protocol. Undergraduate research assistants from Dr. Johnson's lab will contact each participant via telephone on a weekly basis to provide technical assistance and confirm adherence to the training schedule.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Age 65 years or older

• Vision at least 20/40 with glass or contacts

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aging

Intervention

Behavioral:
• Vocal exercise with real-time feedback
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.
• Vocal exercise with recording
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

Locations

Country	Name	City	State
United States	University of Illinois at Urbana-Champaign	Champaign	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Urbana-Champaign

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Vocal aerodynamic function	Phonation threshold pressure (kPa)	8-week change from baseline	No
Secondary	Program engagement and app usability	Assessed via self-report (and verified via objective data) weekly during intervention and computed as an un-weighted composite score reflecting 8-week program adherence and ease of use.	8-week training period	No
Secondary	Training-induced Change in Voice-related Quality of Life	The London Chest Activity of Daily Living Scale will be used to assess theoretical and mechanistic components of the vocal exercise intervention. Un-weight composite scores will be calculated at each assessment.	8-week change from baseline	No
Secondary	Acceptability/feasibility of intervention	Self-reported level of agreement (1 strongly disagree, 7 strongly agree) with three separate statements ("I enjoyed the program I used to exercise my voice," "I will continue to use the training techniques in the future," and "I believe my voice improved as a result of my participation in this program")	Post-intervention (8-week follow-up)	No
Secondary	Respiratory Function	FEV1 - forced expiratory volume in 1 second (Liters)	8-week change from baseline	No