<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/NCT03805529</url>
  </required_header>
  <id_info>
    <org_study_id>26191</org_study_id>
    <nct_id>NCT03805529</nct_id>
  </id_info>
  <brief_title>The Singing Heart Study</brief_title>
  <official_title>Effect of Singing on Endothelial Function and Cardiac Autonomic Regulation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical College of Wisconsin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical College of Wisconsin</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This pilot study will help evaluate the effect of singing on heart rate variability and&#xD;
      endothelial function (markers of cardiac health). If study results are positive this will&#xD;
      support more research on the use of singing in cardiac rehabilitation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The intent of this protocol is to evaluate the impact of singing on cardiac hemodynamics and&#xD;
      endothelial function, a marker of cardiovascular health and future cardiac risk.&#xD;
&#xD;
      The study is designed to consist of an initial phone screen and 1 index visit. All&#xD;
      study-related procedures will be performed by a trained member of the research team. Dr.&#xD;
      Kulinski will provide oversight of all study related procedures and will be ultimately&#xD;
      responsible for validation of eligibility, and completion of all study-related tasks.&#xD;
      Patients in the cardiology clinics at Froedtert Hospital will be made aware of this study by&#xD;
      the clinic staff. If interested in participating, the patient will be provided with the study&#xD;
      coordinator's phone number and the study team will be provided with the patient's contact&#xD;
      information. The study team will first screen the potential subject via a phone conversation.&#xD;
&#xD;
      Once the subject is deemed eligible based on the legibility criteria, they will be mailed a&#xD;
      copy of the Institutional Review Board (IRB) consent form to review. If after reviewing&#xD;
      information about the study, the potential subject remains interested, a 90-minute visit&#xD;
      (with reserved clinic exam room) will be scheduled for the same day as their upcoming clinic&#xD;
      appointment (or another day if preferred by the subject). Recruited subjects will be advised&#xD;
      to remain fasting (for a minimum of at least 3 hours) until their research study appointment&#xD;
      has been completed. They can drink water.&#xD;
&#xD;
      The study subjects will be called from the clinic waiting room at the time of their&#xD;
      appointment. The subject will be taken to a quiet clinic exam room for the visit. Phones,&#xD;
      beepers and other devices which can cause startling noises should be turned off. restrictive&#xD;
      clothing that could interfere with blood flow to the arms will be removed. We will ask the&#xD;
      subject to remove watches, rings, or other jewelry on the hands or fingers.&#xD;
&#xD;
      Baseline vital signs (resting heart rate, blood pressure, pulse oximetry), weight and height&#xD;
      will be obtained. Blood pressure will be measured from the subject's control arm (dominant&#xD;
      arm preferred). The non-dominant arm is recommended as the tested (occluded) arm by the&#xD;
      manufacturer. The appropriately-sized (Bluetooth-capable) Heart Rate Variability (HRV) heart&#xD;
      rate sensor strap will be applied to the subject as shown (picture). It is recommended to&#xD;
      allow 5 minutes to pass between the time of blood pressure measurement and the commencement&#xD;
      of the EndoPAT recording. The subject will be asked to refrain from talking. Staff should&#xD;
      avoid talking to the subject and between themselves as much as possible. During this time,&#xD;
      the blood pressure cuff will be moved to the non-dominant upper arm, and subjects' fingers&#xD;
      will be placed into the probes with subject's forearms supported on the arm supports. The&#xD;
      index finger is recommended for the study; however, if this finger is unsuitable, a different&#xD;
      digit (except the thumb) may be used, so long as the same finger is used on both hands.&#xD;
      Written informed consent will be obtained. Subject's positional comfort will be maximized.&#xD;
      The subject will be instructed to refrain from moving the fingers to the extent possible.&#xD;
&#xD;
      After 5 minutes since blood pressure was taken, baseline EndoPAT measurements will be&#xD;
      obtained. Endo-PAT device will be placed on subjects to measure reactive hyperemia index&#xD;
      (RHI) according to a standard protocol (please also see uploaded Endo-PAT manual). Briefly,&#xD;
      this includes a stable period of baseline signal recording, followed by rapid inflation of&#xD;
      the blood pressure cuff to a supra-systolic level at least 60 mm Hg above systolic blood&#xD;
      pressure and no less than 200 mm Hg. Total cessation of blood flow will be verified by total&#xD;
      absence of EndoPAT signal from the occluded hand. This occlusion will be maintained for&#xD;
      exactly 5 minutes. This may cause mild stress and/or discomfort to the subject, who will be&#xD;
      closely monitored. After 5 minutes exactly, the cuff will be completely deflated as quickly&#xD;
      as possible. The EndoPAT signal will be recorded for an additional 5 minutes.&#xD;
&#xD;
      The research team member will assist the subject in completing pages 1-4 of the study&#xD;
      questionnaire, including demographics, medical history, current medications, current exercise&#xD;
      and singing habits and physical limitations and/or mobility issues.&#xD;
&#xD;
      Next, the research team will verify Bluetooth connection to the research iPAD. NO subject&#xD;
      information will need to be entered on the iPAD. A 1-minute &quot;pre-singing&quot; baseline HRV&#xD;
      measurement will be obtained and recorded (refer to uploaded Data Collection Sheet). An&#xD;
      automated blood pressure, heart rate and pulse oximetry will be recorded. A pulse oximetry&#xD;
      finger probe will remain in place. In a seated position, the subject will watch and sing&#xD;
      along to the 10-minute coaching video that includes a warm-up with vocal exercise and the&#xD;
      lyrics to the Star-Spangled Banner, created by co-investigator Tanya Kruse Ruck, DMA,&#xD;
      assistant professor of voice at the University of Milwaukee. Approximately 7 minutes into the&#xD;
      (10-minute) singing video, a &quot;singing&quot; HRV measurement and automated blood pressure, heart&#xD;
      rate and pulse oximetry will be obtained and recorded. The heart rate immediately after&#xD;
      singing will be recorded. A &quot;post-singing&quot; HRV measurement will be obtained. After the&#xD;
      1-minute post HRV measurement, the heart rate will be recorded (this will allow us to&#xD;
      determine 1-minute heart rate recovery). Another blood pressure and pulse oximetry will be&#xD;
      recorded. The pulse oximetry probe will be removed, and the subject's fingers connected to a&#xD;
      new set of EndoPAT disposable finger probes.&#xD;
&#xD;
      A second EndoPAT measurement will be started immediately according to the same protocol as&#xD;
      above.&#xD;
&#xD;
      The subject will be asked to rate the highest level of exertion while singing, according to&#xD;
      the Borg scale. The research team member will record their observation of the subject's&#xD;
      singing effort The subject will be asked to complete questions relating to their visit&#xD;
      experience.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 22, 2018</start_date>
  <completion_date type="Actual">July 17, 2020</completion_date>
  <primary_completion_date type="Actual">August 20, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The change in heart rate variability during singing</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Use a professional singing coach to guide subjects through a 10-minute period of singing</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The change from baseline vascular endothelial function in subjects who've participated in singing intervention</measure>
    <time_frame>Change from baseline endothelial function after 10 minutes of singing</time_frame>
    <description>Measure endothelial function (reactive hyperemia index, RHI) through finger plethysmography using EndoPAT</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The change in cardiac hemodynamics</measure>
    <time_frame>Change from baseline heart rate variability after 10 minutes of singing</time_frame>
    <description>Heart rate variability will be measured before, during and post singing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change in cardiac hemodynamics</measure>
    <time_frame>Change from baseline blood pressure variability after 10 minutes of singing</time_frame>
    <description>blood pressure will be measured before, during and post singing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change in cardiac hemodynamics</measure>
    <time_frame>Change from baseline heart rate variability after 10 minutes of singing</time_frame>
    <description>Heart rate will be measured before, during and post singing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change in cardiac hemodynamics</measure>
    <time_frame>Change from baseline pulse ox. after 10 minutes of singing</time_frame>
    <description>Pulse ox. will be measured before, during and post singing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Asses subjects' self-assessment of perceived exertion during singing</measure>
    <time_frame>after 10 minutes of singing</time_frame>
    <description>subjects perceived exertion during singing using qualitative Borg Rated Perceived Exertion Scale and correlate with changes in cardiac hemodynamics and heart rate variability. Scale is numerical from 6-20, 6 being no exertion at all and 20 being maximal exertion.</description>
  </secondary_outcome>
  <enrollment type="Actual">60</enrollment>
  <condition>Impact of Singing</condition>
  <condition>Cardiovascular Health</condition>
  <condition>Cardiovascular Risk Factors</condition>
  <condition>Cardiovascular Diseases</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Cardiology clinic patients age ≥ 18, willing and able to sign informed consent&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cardiology clinic patients age ≥ 18, willing and able to sign informed consent&#xD;
&#xD;
          -  Fasting for at least 3 hours (by time of research appointment)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with a permanent pacemaker or implantable cardioverter defibrillator (ICD)&#xD;
             implanted&#xD;
&#xD;
          -  Patients with a history of atrial fibrillation&#xD;
&#xD;
          -  Parkinson's disease or a tremor&#xD;
&#xD;
          -  Amputated upper extremity or presence of upper-arm (dialysis) fistula&#xD;
&#xD;
          -  Fingernail onychomycosis (fungal infections resulting in thickening of the nails)&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Current illicit drug use (marijuana, tobacco, cocaine, amphetamines, etc.)&#xD;
&#xD;
          -  Current excessive alcohol use (defined as more than 14 drinks/week for women, more&#xD;
             than 28 drinks/week for men)&#xD;
&#xD;
          -  Unstable coronary heart disease (active symptoms of chest discomfort)&#xD;
&#xD;
          -  Subjects requiring supplemental oxygen use&#xD;
&#xD;
          -  Non-english speaking subjects&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Medical College of Wisconsin</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>September 24, 2021</last_update_submitted>
  <last_update_submitted_qc>September 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical College of Wisconsin</investigator_affiliation>
    <investigator_full_name>Jacquelyn Kulinski</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The data may be available to qualified investigators following study completion and initial publication of the data with collaboration with the study PI</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/NCT03805529
org study id: 26191
nct id: NCT03805529
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This pilot study will help evaluate the effect of singing on heart rate variability and
      endothelial function (markers of cardiac health). If study results are positive this will
      support more research on the use of singing in cardiac rehabilitation.
The intent of this protocol is to evaluate the impact of singing on cardiac hemodynamics and
      endothelial function, a marker of cardiovascular health and future cardiac risk.

      The study is designed to consist of an initial phone screen and 1 index visit. All
      study-related procedures will be performed by a trained member of the research team. Dr.
      Kulinski will provide oversight of all study related procedures and will be ultimately
      responsible for validation of eligibility, and completion of all study-related tasks.
      Patients in the cardiology clinics at Froedtert Hospital will be made aware of this study by
      the clinic staff. If interested in participating, the patient will be provided with the study
      coordinator's phone number and the study team will be provided with the patient's contact
      information. The study team will first screen the potential subject via a phone conversation.

      Once the subject is deemed eligible based on the legibility criteria, they will be mailed a
      copy of the Institutional Review Board (IRB) consent form to review. If after reviewing
      information about the study, the potential subject remains interested, a 90-minute visit
      (with reserved clinic exam room) will be scheduled for the same day as their upcoming clinic
      appointment (or another day if preferred by the subject). Recruited subjects will be advised
      to remain fasting (for a minimum of at least 3 hours) until their research study appointment
      has been completed. They can drink water.

      The study subjects will be called from the clinic waiting room at the time of their
      appointment. The subject will be taken to a quiet clinic exam room for the visit. Phones,
      beepers and other devices which can cause startling noises should be turned off. restrictive
      clothing that could interfere with blood flow to the arms will be removed. We will ask the
      subject to remove watches, rings, or other jewelry on the hands or fingers.

      Baseline vital signs (resting heart rate, blood pressure, pulse oximetry), weight and height
      will be obtained. Blood pressure will be measured from the subject's control arm (dominant
      arm preferred). The non-dominant arm is recommended as the tested (occluded) arm by the
      manufacturer. The appropriately-sized (Bluetooth-capable) Heart Rate Variability (HRV) heart
      rate sensor strap will be applied to the subject as shown (picture). It is recommended to
      allow 5 minutes to pass between the time of blood pressure measurement and the commencement
      of the EndoPAT recording. The subject will be asked to refrain from talking. Staff should
      avoid talking to the subject and between themselves as much as possible. During this time,
      the blood pressure cuff will be moved to the non-dominant upper arm, and subjects' fingers
      will be placed into the probes with subject's forearms supported on the arm supports. The
      index finger is recommended for the study; however, if this finger is unsuitable, a different
      digit (except the thumb) may be used, so long as the same finger is used on both hands.
      Written informed consent will be obtained. Subject's positional comfort will be maximized.
      The subject will be instructed to refrain from moving the fingers to the extent possible.

      After 5 minutes since blood pressure was taken, baseline EndoPAT measurements will be
      obtained. Endo-PAT device will be placed on subjects to measure reactive hyperemia index
      (RHI) according to a standard protocol (please also see uploaded Endo-PAT manual). Briefly,
      this includes a stable period of baseline signal recording, followed by rapid inflation of
      the blood pressure cuff to a supra-systolic level at least 60 mm Hg above systolic blood
      pressure and no less than 200 mm Hg. Total cessation of blood flow will be verified by total
      absence of EndoPAT signal from the occluded hand. This occlusion will be maintained for
      exactly 5 minutes. This may cause mild stress and/or discomfort to the subject, who will be
      closely monitored. After 5 minutes exactly, the cuff will be completely deflated as quickly
      as possible. The EndoPAT signal will be recorded for an additional 5 minutes.

      The research team member will assist the subject in completing pages 1-4 of the study
      questionnaire, including demographics, medical history, current medications, current exercise
      and singing habits and physical limitations and/or mobility issues.

      Next, the research team will verify Bluetooth connection to the research iPAD. NO subject
      information will need to be entered on the iPAD. A 1-minute "pre-singing" baseline HRV
      measurement will be obtained and recorded (refer to uploaded Data Collection Sheet). An
      automated blood pressure, heart rate and pulse oximetry will be recorded. A pulse oximetry
      finger probe will remain in place. In a seated position, the subject will watch and sing
      along to the 10-minute coaching video that includes a warm-up with vocal exercise and the
      lyrics to the Star-Spangled Banner, created by co-investigator Tanya Kruse Ruck, DMA,
      assistant professor of voice at the University of Milwaukee. Approximately 7 minutes into the
      (10-minute) singing video, a "singing" HRV measurement and automated blood pressure, heart
      rate and pulse oximetry will be obtained and recorded. The heart rate immediately after
      singing will be recorded. A "post-singing" HRV measurement will be obtained. After the
      1-minute post HRV measurement, the heart rate will be recorded (this will allow us to
      determine 1-minute heart rate recovery). Another blood pressure and pulse oximetry will be
      recorded. The pulse oximetry probe will be removed, and the subject's fingers connected to a
      new set of EndoPAT disposable finger probes.

      A second EndoPAT measurement will be started immediately according to the same protocol as
      above.

      The subject will be asked to rate the highest level of exertion while singing, according to
      the Borg scale. The research team member will record their observation of the subject's
      singing effort The subject will be asked to complete questions relating to their visit
      experience.
observational model: Case-Only
time perspective: Prospective
measure: The change in heart rate variability during singing
time frame: through study completion, an average of 1 year
description: Use a professional singing coach to guide subjects through a 10-minute period of singing
measure: The change from baseline vascular endothelial function in subjects who've participated in singing intervention
time frame: Change from baseline endothelial function after 10 minutes of singing
description: Measure endothelial function (reactive hyperemia index, RHI) through finger plethysmography using EndoPAT
measure: The change in cardiac hemodynamics
time frame: Change from baseline heart rate variability after 10 minutes of singing
description: Heart rate variability will be measured before, during and post singing
measure: The change in cardiac hemodynamics
time frame: Change from baseline blood pressure variability after 10 minutes of singing
description: blood pressure will be measured before, during and post singing
measure: The change in cardiac hemodynamics
time frame: Change from baseline heart rate variability after 10 minutes of singing
description: Heart rate will be measured before, during and post singing
measure: The change in cardiac hemodynamics
time frame: Change from baseline pulse ox. after 10 minutes of singing
description: Pulse ox. will be measured before, during and post singing
measure: Asses subjects' self-assessment of perceived exertion during singing
time frame: after 10 minutes of singing
description: subjects perceived exertion during singing using qualitative Borg Rated Perceived Exertion Scale and correlate with changes in cardiac hemodynamics and heart rate variability. Scale is numerical from 6-20, 6 being no exertion at all and 20 being maximal exertion.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Medical College of Wisconsin
investigator full name: Jacquelyn Kulinski
investigator title: Assistant Professor
mesh term: Cardiovascular Diseases
sharing ipd: Yes
ipd description: The data may be available to qualified investigators following study completion and initial publication of the data with collaboration with the study PI