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/NCT05994261</url>
    </required_header>
    <id_info>
      <org_study_id>IRB00099972</org_study_id>
      <nct_id>NCT05994261</nct_id>
    </id_info>
    <brief_title>Cereset Research Long-Term Healthcare Worker Study</brief_title>
    <acronym>LT-HW</acronym>
    <official_title>Evaluating Long-Term Feasibility of Cereset Research for Stressed Healthcare Workers</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Wake Forest University Health Sciences</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Susanne Marcus Collins Foundation, Inc.</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Wake Forest University Health Sciences</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_unapproved_device>Yes</is_unapproved_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Randomized, controlled study of long-term maintenance Cereset Research after an initial&#xD;
        4-session intervention bolus versus usual care control following an initial 4-session&#xD;
        intervention bolus.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This randomized, controlled study will evaluate the effects of long-term Cereset Research&#xD;
        maintenance intervention in healthcare workers with symptoms of stress in the post era of&#xD;
        COVID-19. Healthcare workers of all types have been impacted personally, professionally, and&#xD;
        financially by the pandemic and its aftermath, resulting in higher levels of stress and&#xD;
        anxiety. Additional, brief, noninvasive, non-drug strategies are needed to help mitigate the&#xD;
        effects of the acute trauma associated with the pandemic. The primary outcome will be change&#xD;
        in Perceived Stress Scale (PSS) a measurement of how different situations affect feelings and&#xD;
        perceived stress in the Intervention group compared to the Control Group. Data will also be&#xD;
        collected on a variety of additional relevant symptoms including insomnia, anxiety and&#xD;
        autonomic cardiovascular regulation, for which benefits have been shown in prior studies&#xD;
        using High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM).&#xD;
        Data collected will assess the long-term effects of a low dose Cereset Research (CR) approach&#xD;
        (only 4 sessions) and the importance of long-term maintenance intervention versus control.&#xD;
        The Intervention Group will then receive 1 session every 6 weeks beginning 6 weeks after the&#xD;
        4 session bolus is completed. The Control Group continues current care with no additional CR&#xD;
        sessions. A successful outcome of reduced stress at 1 year in the Intervention Group vs.&#xD;
        Control Group would suggest benefit for long-term maintenance intervention sessions. The&#xD;
        effect of this approach on autonomic function and other self-reported symptoms will also be&#xD;
        explored. This information will be useful for determining intervention schedules for direct&#xD;
        clinical implementation of the intervention. The proposed study might also help to identify&#xD;
        characteristics of individuals who may experience differential effects/benefits from&#xD;
        application of CR and determine if intermittent &quot;tune-up&quot; sessions may prolong symptom&#xD;
        improvement.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2025</completion_date>
    <primary_completion_date type="Anticipated">September 2024</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>Single Group Assignment</intervention_model>
      <intervention_model_description>Randomized, controlled study of long-term maintenance Cereset Research after an initial 4-session intervention bolus versus usual care control following an initial 4-session intervention bolus.</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in Perceived Stress Scale (PSS) scores</measure>
      <time_frame>Baseline to year 1</time_frame>
      <description>The Perceived Stress Scale (PSS) is a ten-item psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful. Items were designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives. The scale, with answers rated from 0-4, also includes a number of direct queries about current levels of experienced stress. Higher scores suggest increase perceived stress.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in Insomnia Severity Index (ISI) scores</measure>
      <time_frame>Baseline to year 1</time_frame>
      <description>The severity of insomnia symptoms is measured using two self-report symptom inventories with each data collection visit. This includes the Insomnia Severity Index (ISI). The ISI is a 7-question measure, with responses from 0-4 for each question, yielding scores ranging from 0-28. The higher the score, the more suggestive of insomnia.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Generalized Anxiety Disorder-7 (GAD-7) scores</measure>
      <time_frame>Baseline to year 1</time_frame>
      <description>The Generalized Anxiety Disorder-7 (GAD-7) is a seven-item screening tool for anxiety that is widely used in primary care. GAD-7 is a brief, reliable and valid measure of assessing generalized anxiety disorder. Higher scores suggest increased anxiety.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">90</enrollment>
    <condition>Stress</condition>
    <condition>Anxiety</condition>
    <condition>Autonomic Dysregulation</condition>
    <condition>Acoustic Stimulation</condition>
    <condition>Hyperarousal</condition>
    <condition>Health Personnel</condition>
    <arm_group>
      <arm_group_label>Cereset Research Tune-Up Intervention Group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>All study participants will receive 4 initial CR sessions. Afterwards, they will be randomized, and this group will receive an additional tune-up (maintenance) session every 6 weeks for one year. There will be a CR session at weeks 6, 12, 18, 24, 30, 36, 42, and 48.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cereset Research Control Group</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>All study participants will receive 4 initial CR sessions. Afterwards, they will be randomized, and this group will continue their current care for 1 year with no additional CR sessions.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Cereset Research</intervention_name>
      <description>The upgraded platform for medical research using the HIRREM technology has been rebranded as Cereset Research® (CR). This system uses the same core technology and algorithms to echo brainwaves in real-time using audible tones, as with HIRREM. The CR system also includes 64-bit processing architecture for faster feedback, the use of 4 sensors, and the use of standard protocols (with flexibility regarding the length and sequencing of the standard protocols), all done with eyes closed. Four sensors are applied to the scalp at a time. However, only two sensors are actively echoing feedback. The software automatically switches from one sensor pair to the other when needed. This reduces the number of sensor placement changes needed, resulting in shorter session time and fewer interruptions.</description>
      <arm_group_label>Cereset Research Control Group</arm_group_label>
      <arm_group_label>Cereset Research Tune-Up Intervention Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Employed healthcare workers aged 18 years and older.&#xD;
  &#xD;
            -  Have availability and interest in participating in a 1 year study.&#xD;
  &#xD;
            -  Ability to comply with basic instructions and be able to sit still, comfortably during&#xD;
               sessions.&#xD;
  &#xD;
            -  Experiencing symptoms of stress meeting threshold score on the Perceived Stress Scale&#xD;
               (PSS ≥ 14).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  No internet access, as some visits collected electronically&#xD;
  &#xD;
            -  Unable, unwilling, or incompetent to provide informed consent.&#xD;
  &#xD;
            -  Physically unable to come to the study visits, or to sit still, comfortably in a chair&#xD;
               for up to 1 hour.&#xD;
  &#xD;
            -  Severe hearing impairment (because the subject will be using ear buds during CR).&#xD;
  &#xD;
            -  Weight is over the chair limit (400 pounds).&#xD;
  &#xD;
            -  Currently enrolled in another active intervention research study.&#xD;
  &#xD;
            -  Prior use of: HIRREM, HIRREM-SOP, Brainwave Optimization (BWO), Cereset, Cereset&#xD;
               Research, Cereset Home, or a wearable configuration of the same (B2, or B2v2).&#xD;
  &#xD;
            -  Prior use of the following modalities within one month before enrollment:&#xD;
               electroconvulsive therapy (ECT), prior use of transcranial magnetic stimulation (TMS),&#xD;
               transcranial direct current stimulation (TDCS), alpha stimulation, eye movement&#xD;
               desensitization and reprocessing (EMDR), brain spotting, neurofeedback, biofeedback,&#xD;
               or deep brain stimulation (DBS).&#xD;
  &#xD;
            -  Known seizure disorder.&#xD;
  &#xD;
            -  Thoughts of active suicide within the last 3 months.&#xD;
  &#xD;
            -  Current medical student.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Charles H Tegeler, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Wake Forest University Health Sciences</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Study Coordinator</last_name>
      <phone>336-716-9447</phone>
      <email>BBRP@wakehealth.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Charles H Tegeler, MD</last_name>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Atrium Wake Forest Baptist Health</name>
        <address>
          <city>Winston-Salem</city>
          <state>North Carolina</state>
          <zip>27104</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Study Coordinator</last_name>
        <phone>336-716-9447</phone>
        <email>BBRP@wakehealth.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>stress</keyword>
    <keyword>anxiety</keyword>
    <keyword>insomnia</keyword>
    <keyword>Cereset Research</keyword>
    <keyword>hyperarousal</keyword>
    <keyword>brain electrical activity</keyword>
    <keyword>autonomic dysregulation</keyword>
    <keyword>neurotechnology</keyword>
    <keyword>HIRREM</keyword>
    <keyword>allostasis</keyword>
    <keyword>neuromodulation</keyword>
    <keyword>acoustic stimulation</keyword>
    <keyword>COVID-19</keyword>
    <keyword>healthcare worker</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Autonomic Nervous System Diseases</mesh_term>
      <mesh_term>Primary Dysautonomias</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/NCT05994261
  org study id: IRB00099972
  nct id: NCT05994261
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  is us export: No
  Randomized, controlled study of long-term maintenance Cereset Research after an initial
        4-session intervention bolus versus usual care control following an initial 4-session
        intervention bolus.
  This randomized, controlled study will evaluate the effects of long-term Cereset Research
        maintenance intervention in healthcare workers with symptoms of stress in the post era of
        COVID-19. Healthcare workers of all types have been impacted personally, professionally, and
        financially by the pandemic and its aftermath, resulting in higher levels of stress and
        anxiety. Additional, brief, noninvasive, non-drug strategies are needed to help mitigate the
        effects of the acute trauma associated with the pandemic. The primary outcome will be change
        in Perceived Stress Scale (PSS) a measurement of how different situations affect feelings and
        perceived stress in the Intervention group compared to the Control Group. Data will also be
        collected on a variety of additional relevant symptoms including insomnia, anxiety and
        autonomic cardiovascular regulation, for which benefits have been shown in prior studies
        using High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM).
        Data collected will assess the long-term effects of a low dose Cereset Research (CR) approach
        (only 4 sessions) and the importance of long-term maintenance intervention versus control.
        The Intervention Group will then receive 1 session every 6 weeks beginning 6 weeks after the
        4 session bolus is completed. The Control Group continues current care with no additional CR
        sessions. A successful outcome of reduced stress at 1 year in the Intervention Group vs.
        Control Group would suggest benefit for long-term maintenance intervention sessions. The
        effect of this approach on autonomic function and other self-reported symptoms will also be
        explored. This information will be useful for determining intervention schedules for direct
        clinical implementation of the intervention. The proposed study might also help to identify
        characteristics of individuals who may experience differential effects/benefits from
        application of CR and determine if intermittent "tune-up" sessions may prolong symptom
        improvement.
  allocation: Randomized
  intervention model: Single Group Assignment
  intervention model description: Randomized, controlled study of long-term maintenance Cereset Research after an initial 4-session intervention bolus versus usual care control following an initial 4-session intervention bolus.
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Change in Perceived Stress Scale (PSS) scores
  time frame: Baseline to year 1
  description: The Perceived Stress Scale (PSS) is a ten-item psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful. Items were designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives. The scale, with answers rated from 0-4, also includes a number of direct queries about current levels of experienced stress. Higher scores suggest increase perceived stress.
  measure: Change in Insomnia Severity Index (ISI) scores
  time frame: Baseline to year 1
  description: The severity of insomnia symptoms is measured using two self-report symptom inventories with each data collection visit. This includes the Insomnia Severity Index (ISI). The ISI is a 7-question measure, with responses from 0-4 for each question, yielding scores ranging from 0-28. The higher the score, the more suggestive of insomnia.
  measure: Change in Generalized Anxiety Disorder-7 (GAD-7) scores
  time frame: Baseline to year 1
  description: The Generalized Anxiety Disorder-7 (GAD-7) is a seven-item screening tool for anxiety that is widely used in primary care. GAD-7 is a brief, reliable and valid measure of assessing generalized anxiety disorder. Higher scores suggest increased anxiety.
  arm group label: Cereset Research Tune-Up Intervention Group
  arm group type: Active Comparator
  description: All study participants will receive 4 initial CR sessions. Afterwards, they will be randomized, and this group will receive an additional tune-up (maintenance) session every 6 weeks for one year. There will be a CR session at weeks 6, 12, 18, 24, 30, 36, 42, and 48.
  arm group label: Cereset Research Control Group
  arm group type: Other
  description: All study participants will receive 4 initial CR sessions. Afterwards, they will be randomized, and this group will continue their current care for 1 year with no additional CR sessions.
  intervention type: Device
  intervention name: Cereset Research
  description: The upgraded platform for medical research using the HIRREM technology has been rebranded as Cereset Research® (CR). This system uses the same core technology and algorithms to echo brainwaves in real-time using audible tones, as with HIRREM. The CR system also includes 64-bit processing architecture for faster feedback, the use of 4 sensors, and the use of standard protocols (with flexibility regarding the length and sequencing of the standard protocols), all done with eyes closed. Four sensors are applied to the scalp at a time. However, only two sensors are actively echoing feedback. The software automatically switches from one sensor pair to the other when needed. This reduces the number of sensor placement changes needed, resulting in shorter session time and fewer interruptions.
  arm group label: Cereset Research Control Group
  arm group label: Cereset Research Tune-Up Intervention Group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 100 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Charles H Tegeler, MD
  role: Principal Investigator
  affiliation: Wake Forest University Health Sciences
  last name: Study Coordinator
  phone: 336-716-9447
  email: BBRP@wakehealth.edu
  last name: Charles H Tegeler, MD
  facility: 
  contact: 
  country: United States
  responsible party type: Sponsor
  mesh term: Autonomic Nervous System Diseases
  mesh term: Primary Dysautonomias
  sharing ipd: No