<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03015870</url>
  </required_header>
  <id_info>
    <org_study_id>IRB15130</org_study_id>
    <nct_id>NCT03015870</nct_id>
  </id_info>
  <brief_title>Technology-assisted Vocal Exercise for Older Adults</brief_title>
  <official_title>Technology-assisted Vocal Exercise for Older Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Illinois at Urbana-Champaign</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Illinois at Urbana-Champaign</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Many detrimental effects of aging have been identified in the human voice, most of which are&#xD;
      accepted as &quot;normal&quot;. However, age-related vocal deficits disrupt communication and decrease&#xD;
      quality of life in older adults and may be preventable and/or treatable through behavioral&#xD;
      interventions. The objective of this proposal is to determine the effectiveness of a&#xD;
      technology-assisted vocal exercise intervention on the vocal function and quality of life in&#xD;
      older adults. Forty older adults (65+) will be recruited and randomly assigned to either an&#xD;
      app or PDF-delivered vocal training intervention lasting 8 weeks. Pre- and post-testing&#xD;
      involving vocal functioning assessments, as well as mobility, psychosocial, and cognitive&#xD;
      functioning assessments will be conducted. This interdisciplinary project will enhance the&#xD;
      investigators understanding of physical, mental, and social health-related quality of life&#xD;
      among older adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All participants will receive an iPad pre-loaded with an instructional PDF containing written&#xD;
      instructions and embedded recorded audio prompts to assist with the delivery of an&#xD;
      established vocal training paradigm, the Vocal Function Exercises (VFE) developed by&#xD;
      Stemple.22 The VFE involves a set of four exercises focusing on extending maximum phonation&#xD;
      time, increasing pitch range, and, therefore, improving coordination of the respiratory,&#xD;
      phonatory, and resonatory systems during voicing. The iPads will be collected from the&#xD;
      participants at the conclusion of the study at the post-intervention testing sessions.&#xD;
&#xD;
      Participants will be randomly assigned to either an experimental feedback group or active&#xD;
      control no feedback group. Participants in the feedback group will receive iPads pre-loaded&#xD;
      with Sonneta Voice Monitor app (MintLeaf Software) which will provide tailored feedback&#xD;
      regarding pitch, loudness, and duration of phonation during practice sessions. The no&#xD;
      feedback group will be provided with an iPad pre-installed with the PDF for the full duration&#xD;
      of the study, but no feedback app.&#xD;
&#xD;
      Prior to and separate from the individual baseline testing appointments (described below),&#xD;
      one group-based introductory session will be held to orient all participants to iPad controls&#xD;
      (i.e., navigation, volume, recordings), as well as training specific to their assigned&#xD;
      condition (how to use the pdf or app). Participants will complete a progressive weekly&#xD;
      training schedule (3, 4, 5, 6, 7, 7, 7, &amp; 7 days per week) 2x per day for 30-minute sessions&#xD;
      over 8 weeks. The first training session will be monitored to provide technical assistance&#xD;
      and ensure fidelity of the training protocol. Undergraduate research assistants from Dr.&#xD;
      Johnson's lab will contact each participant via telephone on a weekly basis to provide&#xD;
      technical assistance and confirm adherence to the training schedule.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Vocal acoustic function</measure>
    <time_frame>8-week change from baseline</time_frame>
    <description>Dysphonia Severity Index: composite measure of maximum phonation time (s), highest fundamental frequency (Hz), lowest intensity (dB) and jitter (%).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vocal aerodynamic function</measure>
    <time_frame>8-week change from baseline</time_frame>
    <description>Phonation threshold pressure (kPa)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Program engagement and app usability</measure>
    <time_frame>8-week training period</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Training-induced Change in Voice-related Quality of Life</measure>
    <time_frame>8-week change from baseline</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acceptability/feasibility of intervention</measure>
    <time_frame>Post-intervention (8-week follow-up)</time_frame>
    <description>Self-reported level of agreement (1 strongly disagree, 7 strongly agree) with three separate statements (&quot;I enjoyed the program I used to exercise my voice,&quot; &quot;I will continue to use the training techniques in the future,&quot; and &quot;I believe my voice improved as a result of my participation in this program&quot;)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respiratory Function</measure>
    <time_frame>8-week change from baseline</time_frame>
    <description>FEV1 - forced expiratory volume in 1 second (Liters)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Aging</condition>
  <arm_group>
    <arm_group_label>Feedback</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Behavioral: Vocal exercise with real-time feedback.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Recording</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Behavioral: Vocal exercise with recording</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Vocal exercise with real-time feedback</intervention_name>
    <description>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.</description>
    <arm_group_label>Feedback</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Vocal exercise with recording</intervention_name>
    <description>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</description>
    <arm_group_label>Recording</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 65 years or older&#xD;
&#xD;
          -  Vision at least 20/40 with glass or contacts&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Moderate-severe cognitive impairment&#xD;
&#xD;
          -  Currently engaged in regular daily singing practice&#xD;
&#xD;
          -  Currently involved in a research study involving exercise, memory, or vocal&#xD;
             strengthening&#xD;
&#xD;
          -  Currently being treated for a voice disorder by either an ENT or SLP&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aaron M Johnson, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Illinois at Urbana-Champaign</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Illinois at Urbana-Champaign</name>
      <address>
        <city>Champaign</city>
        <state>Illinois</state>
        <zip>61820</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>November 4, 2015</study_first_submitted>
  <study_first_submitted_qc>January 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <last_update_submitted>January 6, 2017</last_update_submitted>
  <last_update_submitted_qc>January 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>vocal dysfunction</keyword>
  <keyword>voice</keyword>
  <keyword>vocal folds</keyword>
  <keyword>vocal aging</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>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.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03015870
org study id: IRB15130
nct id: NCT03015870
lead sponsor: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Vocal acoustic function
time frame: 8-week change from baseline
description: Dysphonia Severity Index: composite measure of maximum phonation time (s), highest fundamental frequency (Hz), lowest intensity (dB) and jitter (%).
measure: Vocal aerodynamic function
time frame: 8-week change from baseline
description: Phonation threshold pressure (kPa)
measure: Program engagement and app usability
time frame: 8-week training period
description: 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.
measure: Training-induced Change in Voice-related Quality of Life
time frame: 8-week change from baseline
description: 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.
measure: Acceptability/feasibility of intervention
time frame: Post-intervention (8-week follow-up)
description: 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")
measure: Respiratory Function
time frame: 8-week change from baseline
description: FEV1 - forced expiratory volume in 1 second (Liters)
arm group label: Feedback
arm group type: Experimental
description: Behavioral: Vocal exercise with real-time feedback.
arm group label: Recording
arm group type: Active Comparator
description: Behavioral: Vocal exercise with recording
intervention type: Behavioral
intervention name: Vocal exercise with real-time feedback
description: 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.
arm group label: Feedback
intervention type: Behavioral
intervention name: Vocal exercise with recording
description: 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
arm group label: Recording
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Aaron M Johnson, PhD
role: Principal Investigator
affiliation: University of Illinois at Urbana-Champaign
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: Yes
ipd description: 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.