<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/NCT03762993</url>
  </required_header>
  <id_info>
    <org_study_id>Vocal restoration programs</org_study_id>
    <nct_id>NCT03762993</nct_id>
  </id_info>
  <brief_title>Controlled Phonation and Vocal Rest Programs After Acute Vocal Exertion in Healthy Adults</brief_title>
  <official_title>Vocal Restoration Programs After Acute Vocal Exertion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Purdue University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Purdue University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The proposed research will investigate the most effective strategy to reduce vocal exertion&#xD;
      reported by speakers in noisy environments. Repeated vocal exertion can lead to voice&#xD;
      problems and therefore identifying effective strategies can lead to better prevention of&#xD;
      acquired voice disorders. This study will compare the effects of vocal rest and controlled&#xD;
      phonation both before and after vocal exertion. The investigators hypothesize that vocal rest&#xD;
      and controlled phonation will mitigate the negative effects of vocal exertion.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 5, 2018</start_date>
  <completion_date type="Actual">July 1, 2020</completion_date>
  <primary_completion_date type="Actual">July 1, 2020</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>Crossover Assignment</intervention_model>
    <intervention_model_description>Within Subject Design</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Phonation Threshold Pressure</measure>
    <time_frame>2.5 hours</time_frame>
    <description>Minimum air pressure required to initiate and sustain vocal fold oscillation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Lung Volume Excursion</measure>
    <time_frame>2.5 hours</time_frame>
    <description>The difference between lung volume initiation and termination on connected speech</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">37</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Healthy Adults</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will complete vocal rest and controlled phonation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Adults reporting Vocal Fatigue</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will complete vocal rest and controlled phonation</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Vocal rest and Controlled Phonation</intervention_name>
    <description>Voice rest and semi occluded vocal tract voice exercises</description>
    <arm_group_label>Healthy Adults</arm_group_label>
    <arm_group_label>Healthy Adults reporting Vocal Fatigue</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  within age range&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Voice Disorders&#xD;
&#xD;
          -  Strong gag reflex&#xD;
&#xD;
          -  Craniofacial disorders&#xD;
&#xD;
          -  Cognitive Impairments&#xD;
&#xD;
          -  Head and Neck Cancer&#xD;
&#xD;
          -  Hearing Difficulties&#xD;
&#xD;
          -  Dentition problems that prevent an oral scope being placed in mouth&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Preeti Sivasankar</last_name>
    <role>Principal Investigator</role>
    <affiliation>Purdue University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Purdue University</name>
      <address>
        <city>West Lafayette</city>
        <state>Indiana</state>
        <zip>47906</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>November 30, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <results_first_submitted>June 24, 2021</results_first_submitted>
  <results_first_submitted_qc>August 3, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">August 5, 2021</results_first_posted>
  <last_update_submitted>August 3, 2021</last_update_submitted>
  <last_update_submitted_qc>August 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Purdue University</investigator_affiliation>
    <investigator_full_name>Preeti M. Sivasankar</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 22, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/93/NCT03762993/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Of 37 enrolled participants, 31 were assigned to study groups based on self-reported vocal fatigue level.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Healthy Adults</title>
          <description>Participants will complete vocal rest and controlled phonation&#xD;
Vocal rest and Controlled Phonation: Voice rest and semi occluded vocal tract voice exercises</description>
        </group>
        <group group_id="P2">
          <title>Healthy Adults Reporting Vocal Fatigue</title>
          <description>Participants will complete vocal rest and controlled phonation&#xD;
Vocal rest and Controlled Phonation: Voice rest and semi occluded vocal tract voice exercises</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Healthy Adults</title>
          <description>Participants will complete vocal rest and controlled phonation&#xD;
Vocal rest and Controlled Phonation: Voice rest and semi occluded vocal tract voice exercises</description>
        </group>
        <group group_id="B2">
          <title>Healthy Adults Reporting Vocal Fatigue</title>
          <description>Participants will complete vocal rest and controlled phonation&#xD;
Vocal rest and Controlled Phonation: Voice rest and semi occluded vocal tract voice exercises</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="21"/>
            <count group_id="B2" value="10"/>
            <count group_id="B3" value="31"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Vocal Fatigue Index</title>
          <description>The Vocal Fatigue Index measures self-reported vocal fatigue symptoms. The scale is divided into three separately scored sections (two of which were used here). Possible scores range from 0 to 44 on Part 1, and 0 - 20 on part 2. Scores &gt;24 on part 1, or &gt;7 on part 2 are indicative of vocal fatigue.Scores below this range are considered normal.</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <title>Vocal Fatigue Index Part 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4" lower_limit="0" upper_limit="23"/>
                    <measurement group_id="B2" value="24" lower_limit="4" upper_limit="27"/>
                    <measurement group_id="B3" value="4" lower_limit="0" upper_limit="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vocal Fatigue Index Part 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0" lower_limit="0" upper_limit="5"/>
                    <measurement group_id="B2" value="3.5" lower_limit="2" upper_limit="9"/>
                    <measurement group_id="B3" value="2" lower_limit="0" upper_limit="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Phonation Threshold Pressure</title>
        <description>Minimum air pressure required to initiate and sustain vocal fold oscillation</description>
        <time_frame>2.5 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Healthy Adults</title>
            <description>Participants will complete vocal rest and controlled phonation&#xD;
Vocal rest and Controlled Phonation: Voice rest and semi occluded vocal tract voice exercises</description>
          </group>
          <group group_id="O2">
            <title>Healthy Adults Reporting Vocal Fatigue</title>
            <description>Participants will complete vocal rest and controlled phonation&#xD;
Vocal rest and Controlled Phonation: Voice rest and semi occluded vocal tract voice exercises</description>
          </group>
        </group_list>
        <measure>
          <title>Phonation Threshold Pressure</title>
          <description>Minimum air pressure required to initiate and sustain vocal fold oscillation</description>
          <units>cmH20</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-Exertion</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.41" spread="1.26"/>
                    <measurement group_id="O2" value="5.08" spread="1.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-Exertion</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.39" spread="1.8"/>
                    <measurement group_id="O2" value="6.33" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Restoration Strategy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.63" spread="1.32"/>
                    <measurement group_id="O2" value="5.61" spread="1.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Changes in phonation threshold pressure were analyzed using a linear mixed effect model. Fixed factors included in the statistical model included time, group, and restoration strategy (controlled phonation or vocal rest). In addition, appropriate interactions were included and participant was added as a random factor in order to control for individual variation.</non_inferiority_desc>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>P-value is for the effect of time. A priori significance level set at .05</p_value_desc>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Lung Volume Excursion</title>
        <description>The difference between lung volume initiation and termination on connected speech</description>
        <time_frame>2.5 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Healthy Adults</title>
            <description>Participants will complete vocal rest and controlled phonation&#xD;
Vocal rest and Controlled Phonation: Voice rest and semi occluded vocal tract voice exercises</description>
          </group>
          <group group_id="O2">
            <title>Healthy Adults Reporting Vocal Fatigue</title>
            <description>Participants will complete vocal rest and controlled phonation&#xD;
Vocal rest and Controlled Phonation: Voice rest and semi occluded vocal tract voice exercises</description>
          </group>
        </group_list>
        <measure>
          <title>Lung Volume Excursion</title>
          <description>The difference between lung volume initiation and termination on connected speech</description>
          <units>% Vital Capacity</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.5" spread="7.2"/>
                    <measurement group_id="O2" value="14.5" spread="6.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Exertion</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.6" spread="10.6"/>
                    <measurement group_id="O2" value="12.9" spread="6.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Restoration Strategy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.7" spread="11.5"/>
                    <measurement group_id="O2" value="18.4" spread="7.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Changes in lung volumes were analyzed using a linear mixed effect model. Fixed factors included in the statistical model included time, group, and restoration strategy (controlled phonation or vocal rest). In addition, appropriate interactions were included and participant was added as a random factor in order to control for individual variation.</non_inferiority_desc>
            <p_value>&lt;0.01</p_value>
            <p_value_desc>P-value represents effect of group. A priori threshold for significance set at .05</p_value_desc>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Participants were monitored for adverse events from the time consent was obtained until approximately 24 hours following study completion.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Healthy Adults</title>
          <description>Participants will complete vocal rest and controlled phonation&#xD;
Vocal rest and Controlled Phonation: Voice rest and semi occluded vocal tract voice exercises</description>
        </group>
        <group group_id="E2">
          <title>Healthy Adults Reporting Vocal Fatigue</title>
          <description>Participants will complete vocal rest and controlled phonation&#xD;
Vocal rest and Controlled Phonation: Voice rest and semi occluded vocal tract voice exercises</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Preeti Sivasankar</name_or_title>
      <organization>Purdue University</organization>
      <phone>765-494-3788</phone>
      <email>preeti@purdue.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03762993
org study id: Vocal restoration programs
nct id: NCT03762993
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The proposed research will investigate the most effective strategy to reduce vocal exertion
      reported by speakers in noisy environments. Repeated vocal exertion can lead to voice
      problems and therefore identifying effective strategies can lead to better prevention of
      acquired voice disorders. This study will compare the effects of vocal rest and controlled
      phonation both before and after vocal exertion. The investigators hypothesize that vocal rest
      and controlled phonation will mitigate the negative effects of vocal exertion.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Within Subject Design
primary purpose: Treatment
masking: None (Open Label)
measure: Phonation Threshold Pressure
time frame: 2.5 hours
description: Minimum air pressure required to initiate and sustain vocal fold oscillation
measure: Lung Volume Excursion
time frame: 2.5 hours
description: The difference between lung volume initiation and termination on connected speech
arm group label: Healthy Adults
arm group type: Experimental
description: Participants will complete vocal rest and controlled phonation
arm group label: Healthy Adults reporting Vocal Fatigue
arm group type: Experimental
description: Participants will complete vocal rest and controlled phonation
intervention type: Behavioral
intervention name: Vocal rest and Controlled Phonation
description: Voice rest and semi occluded vocal tract voice exercises
arm group label: Healthy Adults
arm group label: Healthy Adults reporting Vocal Fatigue
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Preeti Sivasankar
role: Principal Investigator
affiliation: Purdue University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Purdue University
investigator full name: Preeti M. Sivasankar
investigator title: Professor
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 