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/NCT05972486</url>
    </required_header>
    <id_info>
      <org_study_id>23-000081</org_study_id>
      <nct_id>NCT05972486</nct_id>
    </id_info>
    <brief_title>A Study of MUSE Device for Midlife Women</brief_title>
    <official_title>MUSE Device to Improve Sleep Quality in Midlife Women</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Mayo Clinic</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Mayo Clinic</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to see if it is feasible for midlife women to wear a brain&#xD;
        activity sensing headband (Muse-S) for management of sleep disturbances such as insomnia and&#xD;
        sleep disruption&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 1, 2023</start_date>
    <completion_date type="Anticipated">March 2024</completion_date>
    <primary_completion_date type="Anticipated">March 2024</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>Change in quality of sleep</measure>
      <time_frame>Baseline, 3 months, 6 months</time_frame>
      <description>Measured using the self-reported Pittsburgh Sleep Quality Index (PSQI) to assess the severity of sleep disturbances. Possible scores range from 0 to 21 with higher scores indicating a worse outcome/more severe symptoms of sleep disturbance.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in sleep impact</measure>
      <time_frame>Baseline, 3 months, 6 months</time_frame>
      <description>Measured using the self-reported ASCQ-Me Sleep Impact Short Form. The 5-item questionnaire used to assess functioning and wellbeing in accordance with sleep. The questions in this assessment tool ask how often they felt sleep impacted specific activities during the the past 7 days. Possible answers include: 0 - never; 1 - rarely; 2 - sometimes; 3 - often, and 4 - always. Possible scores range from 0 to 24, with lower scores indicating a better outcome.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in perceived stress levels</measure>
      <time_frame>Baseline, 3 months, 6 months</time_frame>
      <description>Measured using the self-reported Perceived Stress Scale (PSS). The 10-item questionnaire measures global perceived stress experienced by the participant over the preceding 30 days. The questions in this assessment tool ask how often the participant felt or thought a certain way during the past month. Possible answers include: 0 - never; 1 - almost never; 2 - sometimes; 3 - fairly often, and 4 - very often. Possible scores range from 0 to 40, with lower scores indicating a better outcome (less stress).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in perceived anxiety</measure>
      <time_frame>Baseline, 3 months, 6 months</time_frame>
      <description>Measured using the self-reported Generalized Anxiety Disorder Scale (GAD-7). The 7-item questionnaire assess severity of generalized anxiety disorder. Scoring is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of &quot;not at all,&quot; &quot;several days,&quot; &quot;more than half the days,&quot; and &quot;nearly every day.&quot; Total score for the seven items ranges from 0 to 21 where 0 is no anxiety, 1-4 is minimal anxiety, 5-9 is mild anxiety, 10-14 is moderate anxiety, and 15-21 is severe anxiety.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in sexual function</measure>
      <time_frame>Baseline, 3 months, 6 months</time_frame>
      <description>Measured using the self-reported Female Sexual Function Index (FSFI). The 19-item questionnaire to assess the sexual functioning in women. The questions in this assessment tool ask participants about a specific sexual function within the past 4 weeks on a Likert scale range of 0-5. Total scores range from 2 to 36, with lower scores indicating worse sexual functioning.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in sexual distress</measure>
      <time_frame>Baseline, 3 months, 6 months</time_frame>
      <description>Measured using the Female Sexual Distress Scale (FSDS-R). The 13-item questionnaire to assess sexually related personal distress over the pas 30 days. The questions in this assessment tool asks how often the participant felt during the past month. Possible answers include: 0 - never; 1 - rarely; 2 - occasionally; 3 - frequently, and 4 - always. Possible scores range from 0 to 60, with higher scores indicating greater level of distress.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in quality of life</measure>
      <time_frame>Baseline, 3 months, 6 months</time_frame>
      <description>Measured using the self-reported Patient Health Questionnaire (PHQ-9). The 9-item questionnaire used to assess severity of depression. Scoring is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of &quot;not at all,&quot; &quot;several days,&quot; &quot;more than half the days,&quot; and &quot;nearly every day.&quot; Total score for the seven items ranges from 0 to 27 where 0 is no depression, 1-4 is minimal depression, 5-9 is mild depression, 10-14 is moderate depression, and 15-19 is moderately severe depression and 20-27 severe depression.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Women's Health</condition>
    <condition>Insomnia</condition>
    <condition>Sleep Disturbance</condition>
    <arm_group>
      <arm_group_label>Muse-S headband system for management of sleep disturbances</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Study participants will receive a new Muse-S headband system at study entry and will be asked to utilize it daily for a minimum of 10 minutes day for a period of 6 months (24 weeks). Three of the seven sessions per week will specifically be asked to be mind meditation.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Muse-S™ headband system</intervention_name>
      <description>Clinical grade, headband-style wireless EEG (electroencephalogram is a test used to evaluate the electrical activity in the brain) system and designed to interact with a mobile device (a smartphone or tablet). The device is a soft, stretchy band that fits around the forehead to the back of the head.</description>
      <arm_group_label>Muse-S headband system for management of sleep disturbances</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Women in the menopause transition or in menopause, based on clinical assessment&#xD;
  &#xD;
            -  PSQI score &gt; 5, with overall sleep quality rating of &quot;fairly bad&quot; or &quot;very bad&quot;.&#xD;
  &#xD;
            -  Motivation VAS score equal to or greater than 5 with overall motivation rating of on a&#xD;
               scale of 0-10 with 0 being not motivated at all and 10 being extremely motivated.&#xD;
  &#xD;
            -  Access to an iPad, iPhone, or android device.&#xD;
  &#xD;
            -  Have ability to provide informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Suspected or confirmed obstructive sleep apnea.&#xD;
  &#xD;
            -  Moderate to severe vasomotor symptoms warranting prescription medication use. The FDA&#xD;
               categories for hot flash severity are classified as mild (sensation of heat without&#xD;
               sweating), moderate (sensation of heat with sweating, able to continue activity), or&#xD;
               severe (sensation of heat with sweating cause cessation of activity).&#xD;
  &#xD;
            -  Use of hormone therapy or hypnotic agents.&#xD;
  &#xD;
            -  Use of supplements known to affect sleep.&#xD;
  &#xD;
            -  A known, active, untreated clinically significant psychiatric condition.&#xD;
  &#xD;
            -  Use of an investigational drug within 30 days of study enrollment or presence of a&#xD;
               known history of any condition or factor judged by the investigator to preclude&#xD;
               participation in the study or which might hinder adherence.&#xD;
  &#xD;
            -  Currently (within the past 3 weeks) been practicing mindfulness training on a&#xD;
               weekly/regular basis.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>45 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Amber Klindworth, PA-C</last_name>
      <role>Principal Investigator</role>
      <affiliation>Mayo Clinic</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Katie Cruz, ACRC</last_name>
      <phone>507-284-5404</phone>
      <email>Cruz.Katie@mayo.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Mayo Clinic Minnesota</name>
        <address>
          <city>Rochester</city>
          <state>Minnesota</state>
          <zip>55905</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Katie Cruz</last_name>
        <email>cruz.katie@mayo.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>https://www.mayo.edu/research/clinical-trials</url>
      <description>Mayo Clinic Clinical Trials</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Mayo Clinic</investigator_affiliation>
      <investigator_full_name>Amber L. Klindworth</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dyssomnias</mesh_term>
      <mesh_term>Parasomnias</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/NCT05972486
  org study id: 23-000081
  nct id: NCT05972486
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  The purpose of this study is to see if it is feasible for midlife women to wear a brain
        activity sensing headband (Muse-S) for management of sleep disturbances such as insomnia and
        sleep disruption
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Change in quality of sleep
  time frame: Baseline, 3 months, 6 months
  description: Measured using the self-reported Pittsburgh Sleep Quality Index (PSQI) to assess the severity of sleep disturbances. Possible scores range from 0 to 21 with higher scores indicating a worse outcome/more severe symptoms of sleep disturbance.
  measure: Change in sleep impact
  time frame: Baseline, 3 months, 6 months
  description: Measured using the self-reported ASCQ-Me Sleep Impact Short Form. The 5-item questionnaire used to assess functioning and wellbeing in accordance with sleep. The questions in this assessment tool ask how often they felt sleep impacted specific activities during the the past 7 days. Possible answers include: 0 - never; 1 - rarely; 2 - sometimes; 3 - often, and 4 - always. Possible scores range from 0 to 24, with lower scores indicating a better outcome.
  measure: Change in perceived stress levels
  time frame: Baseline, 3 months, 6 months
  description: Measured using the self-reported Perceived Stress Scale (PSS). The 10-item questionnaire measures global perceived stress experienced by the participant over the preceding 30 days. The questions in this assessment tool ask how often the participant felt or thought a certain way during the past month. Possible answers include: 0 - never; 1 - almost never; 2 - sometimes; 3 - fairly often, and 4 - very often. Possible scores range from 0 to 40, with lower scores indicating a better outcome (less stress).
  measure: Change in perceived anxiety
  time frame: Baseline, 3 months, 6 months
  description: Measured using the self-reported Generalized Anxiety Disorder Scale (GAD-7). The 7-item questionnaire assess severity of generalized anxiety disorder. Scoring is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." Total score for the seven items ranges from 0 to 21 where 0 is no anxiety, 1-4 is minimal anxiety, 5-9 is mild anxiety, 10-14 is moderate anxiety, and 15-21 is severe anxiety.
  measure: Change in sexual function
  time frame: Baseline, 3 months, 6 months
  description: Measured using the self-reported Female Sexual Function Index (FSFI). The 19-item questionnaire to assess the sexual functioning in women. The questions in this assessment tool ask participants about a specific sexual function within the past 4 weeks on a Likert scale range of 0-5. Total scores range from 2 to 36, with lower scores indicating worse sexual functioning.
  measure: Change in sexual distress
  time frame: Baseline, 3 months, 6 months
  description: Measured using the Female Sexual Distress Scale (FSDS-R). The 13-item questionnaire to assess sexually related personal distress over the pas 30 days. The questions in this assessment tool asks how often the participant felt during the past month. Possible answers include: 0 - never; 1 - rarely; 2 - occasionally; 3 - frequently, and 4 - always. Possible scores range from 0 to 60, with higher scores indicating greater level of distress.
  measure: Change in quality of life
  time frame: Baseline, 3 months, 6 months
  description: Measured using the self-reported Patient Health Questionnaire (PHQ-9). The 9-item questionnaire used to assess severity of depression. Scoring is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." Total score for the seven items ranges from 0 to 27 where 0 is no depression, 1-4 is minimal depression, 5-9 is mild depression, 10-14 is moderate depression, and 15-19 is moderately severe depression and 20-27 severe depression.
  arm group label: Muse-S headband system for management of sleep disturbances
  arm group type: Experimental
  description: Study participants will receive a new Muse-S headband system at study entry and will be asked to utilize it daily for a minimum of 10 minutes day for a period of 6 months (24 weeks). Three of the seven sessions per week will specifically be asked to be mind meditation.
  intervention type: Device
  intervention name: Muse-S™ headband system
  description: Clinical grade, headband-style wireless EEG (electroencephalogram is a test used to evaluate the electrical activity in the brain) system and designed to interact with a mobile device (a smartphone or tablet). The device is a soft, stretchy band that fits around the forehead to the back of the head.
  arm group label: Muse-S headband system for management of sleep disturbances
  criteria: 
  gender: Female
  minimum age: 45 Years
  maximum age: 60 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Amber Klindworth, PA-C
  role: Principal Investigator
  affiliation: Mayo Clinic
  last name: Katie Cruz, ACRC
  phone: 507-284-5404
  email: Cruz.Katie@mayo.edu
  facility: 
  status: Recruiting
  contact: 
  country: United States
  url: https://www.mayo.edu/research/clinical-trials
  description: Mayo Clinic Clinical Trials
  responsible party type: Principal Investigator
  investigator affiliation: Mayo Clinic
  investigator full name: Amber L. Klindworth
  investigator title: Principal Investigator
  mesh term: Dyssomnias
  mesh term: Parasomnias
  sharing ipd: No