xml: <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/NCT05962476</url>
    </required_header>
    <id_info>
      <org_study_id>HUM00231771</org_study_id>
      <nct_id>NCT05962476</nct_id>
    </id_info>
    <brief_title>Transcutaneous Vibro-Acoustic Therapy in Parkinson Disease</brief_title>
    <official_title>Transcutaneous Vibro-Acoustic Therapy in Parkinson Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Michigan</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Michigan</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Small exploratory pilot study to assess effects of a transcutaneous vibro-acoustic therapy&#xD;
        device (Apollo Neuro) in people with Parkinson's disease (PD).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The overarching goal of this study is to investigate changes in anxiety, nighttime heart rate&#xD;
        variability, and fear of falling in people with PD before and after 3-months usage of a&#xD;
        transcutaneous vibro-acoustic therapy device. Positive findings in this small exploratory&#xD;
        pilot trial may support future studies of transcutaneous vibro-acoustic therapy for&#xD;
        individuals with PD.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 9, 2023</start_date>
    <completion_date type="Anticipated">July 2025</completion_date>
    <primary_completion_date type="Anticipated">July 2025</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 Nighttime Heart Rate Variability</measure>
      <time_frame>after 90-120 days of intervention</time_frame>
      <description>Average heart rate variability during the night, as measured by Oura ring device (measured in s).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Paced Auditory Serial Addition Test score</measure>
      <time_frame>after 90-120 days of intervention</time_frame>
      <description>A measure of cognitive function that assesses auditory information processing speed and flexibility, scored as the total number correct out of 60. Higher scores indicate better performance.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Spielberger State-Trait Anxiety Inventory score</measure>
      <time_frame>after 90-120 days of intervention</time_frame>
      <description>40-item questionnaire to assess anxiety. Scores range from 40-160 with higher scores indicating greater severity of anxiety.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Hamilton Anxiety Scale score</measure>
      <time_frame>after 90-120 days of intervention</time_frame>
      <description>14-item questionnaire to evaluate severity of anxiety symptoms. Scores range from 0-56, with higher scores indicating greater severity of anxiety.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Hamilton Depression Scale score</measure>
      <time_frame>after 90-120 days of intervention</time_frame>
      <description>17-item questionnaire to assess the severity of depression symptoms. Scores range from 0-61, with higher scores indicating more severe depression.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Beck Depression Inventory score</measure>
      <time_frame>after 90-120 days of intervention</time_frame>
      <description>21-item scale to evaluate the severity of depression symptoms. Scores range from 0-63, with higher scores indicating more severe depression.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Beck Anxiety Inventory score</measure>
      <time_frame>after 90-120 days of intervention</time_frame>
      <description>21-item questionnaire to assess the severity of anxiety. Scores range from 0-63, with higher scores indicating greater anxiety.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Geriatric Depression Scale score</measure>
      <time_frame>after 90-120 days of intervention</time_frame>
      <description>15-item questionnaire scored from 0-15, with greater scores indicating greater severity of depression.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Short Activities-specific Balance Confidence Scale score</measure>
      <time_frame>after 90-120 days of intervention</time_frame>
      <description>16-item scale to assess confidence in balance while performing different tasks. Scores range from 0-100 with greater scores indicating greater confidence.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>New Freezing of Gait Questionnaire score</measure>
      <time_frame>after 90-120 days of intervention</time_frame>
      <description>9-item questionnaire evaluating the severity of freezing of gait. Scores range from 0-29, with higher scores indicating more severe freezing of gait.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Instrumental Activities of Daily Living Scale score</measure>
      <time_frame>after 90-120 days of intervention</time_frame>
      <description>8-item questionnaire to assess functional independence. Scores range from 0-8, with higher scores indicating higher functioning.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Insomnia Severity Index score</measure>
      <time_frame>after 90-120 days of intervention</time_frame>
      <description>7-item scale to assess severity of insomnia. Scores range from 0-28, with higher scores indicating greater severity of insomnia.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Epworth Sleepiness Scale score</measure>
      <time_frame>after 90-120 days of intervention</time_frame>
      <description>8-item scale to assess daytime sleepiness. Scores range from 0-24, with higher scores indicating greater daytime sleepiness.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Fatigue severity Scale score</measure>
      <time_frame>after 90-120 days of intervention</time_frame>
      <description>9-item scale to measure the severity of fatigue. Scores range from 9-63, with higher scores indicating greater severity of fatigue.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Perceived Stress Scale score</measure>
      <time_frame>after 90-120 days of intervention</time_frame>
      <description>10-item questionnaire to evaluate perceived levels of stress. Scores range from 0-40, with greater scores indicating greater perceived stress.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Short Fall Efficacy Scale International score</measure>
      <time_frame>after 90-120 days of intervention</time_frame>
      <description>7-item questionnaire to evaluate fear of falling. Scores range from 7-28 with greater scores indicating greater fear of falling.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Fatigue Visual Analogue Scale score (Alternate form)</measure>
      <time_frame>after 90-120 days of intervention</time_frame>
      <description>Scored from 0-100, with higher score indicating greater fatigue.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Mayo Sleep Questionnaire Score on item 8</measure>
      <time_frame>after 90-120 days of intervention</time_frame>
      <description>Item 8 on the Mayo Sleep Questionnaire asks the participant to rate their general level of alertness over the past 3 weeks on a scale from 0 to 10, with 0 indicating they sleep all day and 10 indicating they are fully and normally awake.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Parkinson Disease</condition>
    <arm_group>
      <arm_group_label>Parkinson's Disease</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will use the vibro-acoustic device 90-120 days for 6 hours at night on the Apollo Neuro setting &quot;Sleep and Renew&quot;.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Transcutaneous vibro-acoustic device</intervention_name>
      <description>Wearable device which sends low-frequency sound vibrations through the skin.</description>
      <arm_group_label>Parkinson's Disease</arm_group_label>
      <other_name>Apollo Neuro</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Diagnosed with Parkinson's Disease (Hoehn and Yahr stage 2 or higher)&#xD;
  &#xD;
            -  Individuals on or off dopaminergic therapy&#xD;
  &#xD;
            -  Present of anxiety or panic disorder&#xD;
  &#xD;
            -  Fear of falling&#xD;
  &#xD;
            -  Understanding of use and care of smart phones and devices&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Presence of significant dementia&#xD;
  &#xD;
            -  Disorders which may resemble PD, such as dementia with Lewy bodies, vascular dementia,&#xD;
               normal pressure hydrocephalus, multiple system atrophy, corticobasal ganglionic&#xD;
               degeneration, or toxic causes of parkinsonism.&#xD;
  &#xD;
            -  Patients with a cardiac pacemaker&#xD;
  &#xD;
            -  History of brain surgery or placement of a deep brain stimulator&#xD;
  &#xD;
            -  Psoriasis vulgaris (or other inflammatory skin condition) on or near skin where the&#xD;
               vibro-acoustic device and sleep tracking ring will be donned.&#xD;
  &#xD;
            -  Patients on beta-blockers, benzodiazepines, antipsychotics, and stimulants (except for&#xD;
               the treatment of attention deficit disorder/ADHD).&#xD;
  &#xD;
            -  Pregnancy&#xD;
  &#xD;
            -  Patients who begin cognitive behavioral therapy or a selective serotonin reuptake&#xD;
               inhibitor (SSRI) medication for an anxiety disorder or other psychiatric disorder&#xD;
               after the baseline clinical assessment.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Prabesh Kanel, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Michigan</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jacqueline Caswell</last_name>
      <phone>734-936-0630</phone>
      <email>jcaswel@med.umich.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Domino's Farms</name>
        <address>
          <city>Ann Arbor</city>
          <state>Michigan</state>
          <zip>48105</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Prabesh Kanel, PhD</last_name>
        <phone>734-998-8422</phone>
        <email>prabeshk@med.umich.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 29, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Michigan</investigator_affiliation>
      <investigator_full_name>Prabesh Kanel</investigator_full_name>
      <investigator_title>Research Investigator</investigator_title>
    </responsible_party>
    <keyword>transcutaneous vibro-acoustic therapy</keyword>
    <keyword>anxiety</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Parkinson Disease</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05962476
  org study id: HUM00231771
  nct id: NCT05962476
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Small exploratory pilot study to assess effects of a transcutaneous vibro-acoustic therapy
        device (Apollo Neuro) in people with Parkinson's disease (PD).
  The overarching goal of this study is to investigate changes in anxiety, nighttime heart rate
        variability, and fear of falling in people with PD before and after 3-months usage of a
        transcutaneous vibro-acoustic therapy device. Positive findings in this small exploratory
        pilot trial may support future studies of transcutaneous vibro-acoustic therapy for
        individuals with PD.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Average Nighttime Heart Rate Variability
  time frame: after 90-120 days of intervention
  description: Average heart rate variability during the night, as measured by Oura ring device (measured in s).
  measure: Paced Auditory Serial Addition Test score
  time frame: after 90-120 days of intervention
  description: A measure of cognitive function that assesses auditory information processing speed and flexibility, scored as the total number correct out of 60. Higher scores indicate better performance.
  measure: Spielberger State-Trait Anxiety Inventory score
  time frame: after 90-120 days of intervention
  description: 40-item questionnaire to assess anxiety. Scores range from 40-160 with higher scores indicating greater severity of anxiety.
  measure: Hamilton Anxiety Scale score
  time frame: after 90-120 days of intervention
  description: 14-item questionnaire to evaluate severity of anxiety symptoms. Scores range from 0-56, with higher scores indicating greater severity of anxiety.
  measure: Hamilton Depression Scale score
  time frame: after 90-120 days of intervention
  description: 17-item questionnaire to assess the severity of depression symptoms. Scores range from 0-61, with higher scores indicating more severe depression.
  measure: Beck Depression Inventory score
  time frame: after 90-120 days of intervention
  description: 21-item scale to evaluate the severity of depression symptoms. Scores range from 0-63, with higher scores indicating more severe depression.
  measure: Beck Anxiety Inventory score
  time frame: after 90-120 days of intervention
  description: 21-item questionnaire to assess the severity of anxiety. Scores range from 0-63, with higher scores indicating greater anxiety.
  measure: Geriatric Depression Scale score
  time frame: after 90-120 days of intervention
  description: 15-item questionnaire scored from 0-15, with greater scores indicating greater severity of depression.
  measure: Short Activities-specific Balance Confidence Scale score
  time frame: after 90-120 days of intervention
  description: 16-item scale to assess confidence in balance while performing different tasks. Scores range from 0-100 with greater scores indicating greater confidence.
  measure: New Freezing of Gait Questionnaire score
  time frame: after 90-120 days of intervention
  description: 9-item questionnaire evaluating the severity of freezing of gait. Scores range from 0-29, with higher scores indicating more severe freezing of gait.
  measure: Instrumental Activities of Daily Living Scale score
  time frame: after 90-120 days of intervention
  description: 8-item questionnaire to assess functional independence. Scores range from 0-8, with higher scores indicating higher functioning.
  measure: Insomnia Severity Index score
  time frame: after 90-120 days of intervention
  description: 7-item scale to assess severity of insomnia. Scores range from 0-28, with higher scores indicating greater severity of insomnia.
  measure: Epworth Sleepiness Scale score
  time frame: after 90-120 days of intervention
  description: 8-item scale to assess daytime sleepiness. Scores range from 0-24, with higher scores indicating greater daytime sleepiness.
  measure: Fatigue severity Scale score
  time frame: after 90-120 days of intervention
  description: 9-item scale to measure the severity of fatigue. Scores range from 9-63, with higher scores indicating greater severity of fatigue.
  measure: Perceived Stress Scale score
  time frame: after 90-120 days of intervention
  description: 10-item questionnaire to evaluate perceived levels of stress. Scores range from 0-40, with greater scores indicating greater perceived stress.
  measure: Short Fall Efficacy Scale International score
  time frame: after 90-120 days of intervention
  description: 7-item questionnaire to evaluate fear of falling. Scores range from 7-28 with greater scores indicating greater fear of falling.
  measure: Fatigue Visual Analogue Scale score (Alternate form)
  time frame: after 90-120 days of intervention
  description: Scored from 0-100, with higher score indicating greater fatigue.
  measure: Mayo Sleep Questionnaire Score on item 8
  time frame: after 90-120 days of intervention
  description: Item 8 on the Mayo Sleep Questionnaire asks the participant to rate their general level of alertness over the past 3 weeks on a scale from 0 to 10, with 0 indicating they sleep all day and 10 indicating they are fully and normally awake.
  arm group label: Parkinson's Disease
  arm group type: Experimental
  description: Participants will use the vibro-acoustic device 90-120 days for 6 hours at night on the Apollo Neuro setting "Sleep and Renew".
  intervention type: Device
  intervention name: Transcutaneous vibro-acoustic device
  description: Wearable device which sends low-frequency sound vibrations through the skin.
  arm group label: Parkinson's Disease
  other name: Apollo Neuro
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Prabesh Kanel, PhD
  role: Principal Investigator
  affiliation: University of Michigan
  last name: Jacqueline Caswell
  phone: 734-936-0630
  email: jcaswel@med.umich.edu
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of Michigan
  investigator full name: Prabesh Kanel
  investigator title: Research Investigator
  mesh term: Parkinson Disease
  sharing ipd: No