<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/NCT03231163</url>
  </required_header>
  <id_info>
    <org_study_id>1082672-3</org_study_id>
    <nct_id>NCT03231163</nct_id>
  </id_info>
  <brief_title>Physiological and Perceptual Effects of Music on Resting Metabolic Rate (RMR)</brief_title>
  <official_title>Physiological and Perceptual Effects of Music on Resting Metabolic Rate (RMR)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Old Dominion University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Old Dominion 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 objective of the study is to determine whether music has any effect on resting metabolic&#xD;
      rate (RMR), which is the amount of energy expended at rest. There is currently conflicting&#xD;
      research on how music affects RMR. One problem with RMR testing is that participants often&#xD;
      fall asleep during the test. There can be a 5-10% difference in the metabolic rate between&#xD;
      rest and sleep. If no change in RMR is observed, playing music during an RMR test could be a&#xD;
      potential strategy to prevent participants from falling asleep. Participants will undergo RMR&#xD;
      measurements while listening to no music, relaxing classical music, and self-selected&#xD;
      classical music.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 5, 2017</start_date>
  <completion_date type="Actual">October 3, 2017</completion_date>
  <primary_completion_date type="Actual">October 3, 2017</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>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Daily Resting Metabolic Rate</measure>
    <time_frame>Participants will be randomized to three consecutive 15-minute trials involving listening to no music, classical music, or self-selected relaxing music. RMR will be measured continuously over each 15 min trial.</time_frame>
    <description>RMR will be measured via indirect calorimetry (Parvomedics TrueOne system)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Heart rate</measure>
    <time_frame>Participants will be randomized to three consecutive 15-minute trials involving listening to no music, classical music, or self-selected relaxing music. Heart rate will be measured continuously over each 15 min trial.</time_frame>
    <description>Heart rate will be measured with a Polar chest strap monitor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Excited/bored scale</measure>
    <time_frame>Participants will be randomized to three consecutive 15-minute trials involving listening to no music, classical music, or self-selected relaxing music. Levels of boredom/excitement will be measured at the end of each 15 min trial.</time_frame>
    <description>Participants rate on a 0-9 Likert scale how bored or excited they are.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleepiness scale</measure>
    <time_frame>Participants will be randomized to three consecutive 15-minute trials involving listening to no music, classical music, or self-selected relaxing music. Levels of sleepiness will be measured at the end of each 15 min trial.</time_frame>
    <description>Participants rate on a 0-9 Likert scale how sleepy they are.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Metabolism</condition>
  <arm_group>
    <arm_group_label>No Music</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Relaxing Classical Music</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Self-Selected Relaxing Music</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No Music</intervention_name>
    <description>Participants lie supine on a table while no music is played.</description>
    <arm_group_label>No Music</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Relaxing Classical Music</intervention_name>
    <description>Participants lie supine on a table while classical music is played.</description>
    <arm_group_label>Relaxing Classical Music</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Self-Selected Relaxing Music</intervention_name>
    <description>Participants lie supine on a table while self-selected relaxing music is played.</description>
    <arm_group_label>Self-Selected Relaxing Music</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Exclusion Criteria:&#xD;
&#xD;
          -  Any metabolic disorder, or significant cardiopulmonary disease&#xD;
&#xD;
          -  Taking medications that are known to affect RMR&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Human Performance Laboratory</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23529</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>July 23, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <last_update_submitted>December 18, 2017</last_update_submitted>
  <last_update_submitted_qc>December 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 20, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Old Dominion University</investigator_affiliation>
    <investigator_full_name>Patrick Wilson, PhD</investigator_full_name>
    <investigator_title>Assistant Professor of Exercise Science</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03231163
org study id: 1082672-3
nct id: NCT03231163
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of the study is to determine whether music has any effect on resting metabolic
      rate (RMR), which is the amount of energy expended at rest. There is currently conflicting
      research on how music affects RMR. One problem with RMR testing is that participants often
      fall asleep during the test. There can be a 5-10% difference in the metabolic rate between
      rest and sleep. If no change in RMR is observed, playing music during an RMR test could be a
      potential strategy to prevent participants from falling asleep. Participants will undergo RMR
      measurements while listening to no music, relaxing classical music, and self-selected
      classical music.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Daily Resting Metabolic Rate
time frame: Participants will be randomized to three consecutive 15-minute trials involving listening to no music, classical music, or self-selected relaxing music. RMR will be measured continuously over each 15 min trial.
description: RMR will be measured via indirect calorimetry (Parvomedics TrueOne system)
measure: Heart rate
time frame: Participants will be randomized to three consecutive 15-minute trials involving listening to no music, classical music, or self-selected relaxing music. Heart rate will be measured continuously over each 15 min trial.
description: Heart rate will be measured with a Polar chest strap monitor
measure: Excited/bored scale
time frame: Participants will be randomized to three consecutive 15-minute trials involving listening to no music, classical music, or self-selected relaxing music. Levels of boredom/excitement will be measured at the end of each 15 min trial.
description: Participants rate on a 0-9 Likert scale how bored or excited they are.
measure: Sleepiness scale
time frame: Participants will be randomized to three consecutive 15-minute trials involving listening to no music, classical music, or self-selected relaxing music. Levels of sleepiness will be measured at the end of each 15 min trial.
description: Participants rate on a 0-9 Likert scale how sleepy they are.
arm group label: No Music
arm group type: Placebo Comparator
arm group label: Relaxing Classical Music
arm group type: Experimental
arm group label: Self-Selected Relaxing Music
arm group type: Experimental
intervention type: Other
intervention name: No Music
description: Participants lie supine on a table while no music is played.
arm group label: No Music
intervention type: Other
intervention name: Relaxing Classical Music
description: Participants lie supine on a table while classical music is played.
arm group label: Relaxing Classical Music
intervention type: Other
intervention name: Self-Selected Relaxing Music
description: Participants lie supine on a table while self-selected relaxing music is played.
arm group label: Self-Selected Relaxing Music
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Old Dominion University
investigator full name: Patrick Wilson, PhD
investigator title: Assistant Professor of Exercise Science
sharing ipd: No