<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/NCT03263793</url>
  </required_header>
  <id_info>
    <org_study_id>17-00323</org_study_id>
    <nct_id>NCT03263793</nct_id>
  </id_info>
  <brief_title>High-intensity Group Vocal Exercise to Improve Laryngeal Function in Patients With Parkinson Disease</brief_title>
  <official_title>High-intensity Group Vocal Exercise to Improve Laryngeal Function in Patients With Parkinson Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NYU Langone Health</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 overall goal of this T2 translational research project is to pilot an interdisciplinary&#xD;
      high-intensity group singing program to improve speech and swallowing in patients with&#xD;
      Parkinson's Disease (PD) and to explore the impact of this program on quality of life (QOL).&#xD;
      This research has three specific aims: 1) Determine the effects of a high-intensity group&#xD;
      vocal training program on vocal function and laryngeal structure; 2) Determine the&#xD;
      transference of vocal training to laryngeal aspects of swallowing; 3) Determine the effect of&#xD;
      patient-reported changes in Quality of Life (QOL) as the result of participation in a group&#xD;
      vocal training program.&#xD;
&#xD;
      Twenty patients with Parkinson Disease will be recruited from the Fresco Institute for&#xD;
      Parkinson's &amp; Movement Disorders to participate in a 12-week vocal training program. The&#xD;
      program will train participants using maximum vocal function exercises targeting vocal&#xD;
      deficits specific to PD. Choral singing therapy sessions will be conducted once weekly with&#xD;
      daily home practice exercises based on principles that have been successful in other&#xD;
      intensive PD vocal exercise programs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Deterioration of speech and swallowing is a hallmark of Parkinson Disease (PD). There is&#xD;
      emerging evidence that choral singing benefits people with PD across a range of modalities.&#xD;
      Despite the increasing popularity of &quot;Parkinson's choirs&quot;, rigorous study of these benefits&#xD;
      is lacking. There is a large body of evidence that intense vocal training improves speech and&#xD;
      communication for people with PD. However, the intense training places high demands on&#xD;
      clinical and patient resources and, due to its individualized approach, lacks the potential&#xD;
      psycho-social benefits of a group intervention.&#xD;
&#xD;
      It is hypothesized singing training program will increase vocal loudness, range of&#xD;
      articulation, and prosodic variation during speech. Additionally, given existing evidence for&#xD;
      neuroplastic transference of voice-related interventions to swallowing function, laryngeal&#xD;
      components of swallowing function will also improve post-intervention. Finally, investigators&#xD;
      expect to see improvements in patient-reported QOL measures corresponding with improved&#xD;
      speech and laryngeal function and/or as the result of group interaction.&#xD;
&#xD;
      All participants will complete a standardized battery of assessment pre- and post- treatment&#xD;
      including acoustic and aerodynamic assessment of voice, dynamic magnetic resonance imaging of&#xD;
      speech and swallowing, and videofluoroscopic evaluation of swallowing. The outcome of this&#xD;
      work will be a rigorous understanding of how choral singing therapy can positively impact the&#xD;
      voice, swallowing function, and quality of life for patients with PD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 22, 2017</start_date>
  <completion_date type="Actual">December 13, 2017</completion_date>
  <primary_completion_date type="Actual">December 13, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Average speaking intensity (dB SPL)</measure>
    <time_frame>19 Weeks</time_frame>
    <description>Tasks: Sustained phonation of /a/ at a comfortable pitch and loudness for 4 seconds; pitch glide throughout physiologic vocal range on /a/; standardized reading passage (CAPE-V sentences); 1-minute monologue in response to an emotionally neutral question; singing a standard song.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>Behavioral vocal training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>12-week vocal training program will use maximum vocal function exercises targeting vocal deficits specific to Parkinson Disease.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Choral (group) singing therapy sessions</intervention_name>
    <description>Choral (group) singing therapy sessions will be conducted once weekly and daily home practice exercises will be assigned. All vocal exercises are based on principles that have been successful in other intensive Parkinson Disease vocal exercise programs.</description>
    <arm_group_label>Behavioral vocal training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Confirmed diagnosis of Stage One, Two or Three on the Hoehn and Yahr Staging of&#xD;
             Parkinson's Disease&#xD;
&#xD;
          -  Current swallowing severity of normal, mild, or moderate without aspiration&#xD;
&#xD;
          -  Stable regimen of anti-PD medication for &gt;30 days&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior voice and/or swallowing therapy related to PD&#xD;
&#xD;
          -  History of head and neck cancer&#xD;
&#xD;
          -  History of oropharyngeal or laryngeal surgery&#xD;
&#xD;
          -  Current or former smoker (quit &lt; 5 years)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aaron Johnson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYU Langone Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>New York University School of Medicine</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>August 24, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 28, 2017</study_first_posted>
  <last_update_submitted>August 23, 2018</last_update_submitted>
  <last_update_submitted_qc>August 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>singing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
  </condition_browse>
  <!-- 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/NCT03263793
org study id: 17-00323
nct id: NCT03263793
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The overall goal of this T2 translational research project is to pilot an interdisciplinary
      high-intensity group singing program to improve speech and swallowing in patients with
      Parkinson's Disease (PD) and to explore the impact of this program on quality of life (QOL).
      This research has three specific aims: 1) Determine the effects of a high-intensity group
      vocal training program on vocal function and laryngeal structure; 2) Determine the
      transference of vocal training to laryngeal aspects of swallowing; 3) Determine the effect of
      patient-reported changes in Quality of Life (QOL) as the result of participation in a group
      vocal training program.

      Twenty patients with Parkinson Disease will be recruited from the Fresco Institute for
      Parkinson's & Movement Disorders to participate in a 12-week vocal training program. The
      program will train participants using maximum vocal function exercises targeting vocal
      deficits specific to PD. Choral singing therapy sessions will be conducted once weekly with
      daily home practice exercises based on principles that have been successful in other
      intensive PD vocal exercise programs.
Deterioration of speech and swallowing is a hallmark of Parkinson Disease (PD). There is
      emerging evidence that choral singing benefits people with PD across a range of modalities.
      Despite the increasing popularity of "Parkinson's choirs", rigorous study of these benefits
      is lacking. There is a large body of evidence that intense vocal training improves speech and
      communication for people with PD. However, the intense training places high demands on
      clinical and patient resources and, due to its individualized approach, lacks the potential
      psycho-social benefits of a group intervention.

      It is hypothesized singing training program will increase vocal loudness, range of
      articulation, and prosodic variation during speech. Additionally, given existing evidence for
      neuroplastic transference of voice-related interventions to swallowing function, laryngeal
      components of swallowing function will also improve post-intervention. Finally, investigators
      expect to see improvements in patient-reported QOL measures corresponding with improved
      speech and laryngeal function and/or as the result of group interaction.

      All participants will complete a standardized battery of assessment pre- and post- treatment
      including acoustic and aerodynamic assessment of voice, dynamic magnetic resonance imaging of
      speech and swallowing, and videofluoroscopic evaluation of swallowing. The outcome of this
      work will be a rigorous understanding of how choral singing therapy can positively impact the
      voice, swallowing function, and quality of life for patients with PD.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Average speaking intensity (dB SPL)
time frame: 19 Weeks
description: Tasks: Sustained phonation of /a/ at a comfortable pitch and loudness for 4 seconds; pitch glide throughout physiologic vocal range on /a/; standardized reading passage (CAPE-V sentences); 1-minute monologue in response to an emotionally neutral question; singing a standard song.
arm group label: Behavioral vocal training
arm group type: Experimental
description: 12-week vocal training program will use maximum vocal function exercises targeting vocal deficits specific to Parkinson Disease.
intervention type: Behavioral
intervention name: Choral (group) singing therapy sessions
description: Choral (group) singing therapy sessions will be conducted once weekly and daily home practice exercises will be assigned. All vocal exercises are based on principles that have been successful in other intensive Parkinson Disease vocal exercise programs.
arm group label: Behavioral vocal training
criteria: 
gender: All
minimum age: N/A
maximum age: 100 Years
healthy volunteers: No
last name: Aaron Johnson, MD
role: Principal Investigator
affiliation: NYU Langone Health
facility: 
country: United States
responsible party type: Sponsor
mesh term: Parkinson Disease