<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/NCT03751982</url>
  </required_header>
  <id_info>
    <org_study_id>1R44MH115955</org_study_id>
    <nct_id>NCT03751982</nct_id>
  </id_info>
  <brief_title>Closed Loop TES for Enhancing Slow Wave Sleep</brief_title>
  <official_title>Improving Spatiotemporal Precision in Noninvasive Electrical Neuromodulation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brain Electrophysiology Laboratory Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Brain Electrophysiology Laboratory Company</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>
      Compare closed-loop with open-loop application of TES to enhance slow waves of sleep.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Note: FDA has determined that TES with the stimulus parameters as specified for this trial&#xD;
      presents no significant risk, so that FDA clearance is not required.&#xD;
&#xD;
      Several findings suggest that Transcranial Electrical Stimulation (TES) may be particularly&#xD;
      effective if it is aligned with ongoing brain activity. One condition of the present research&#xD;
      is an open-loop design, in which TES pulses (0.75 Hz pulses; 2.0 mA) are presented during&#xD;
      slow wave sleep. The other condition is a closed-loop design, using identical pulses, but&#xD;
      these will be phase aligned with the slow waves of sleep, measured by the&#xD;
      electroencephalogram (EEG). The hypothesis is that closed-loop TES will be more effective in&#xD;
      enhancing the amplitude and duration of slow wave sleep than open-loop TES.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 14, 2020</start_date>
  <completion_date type="Anticipated">January 14, 2022</completion_date>
  <primary_completion_date type="Anticipated">January 14, 2021</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>Within subjects comparison of two effective treatments. Order of treatment is randomized and counterbalanced.</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>The phase alignment of the treatment is set in software and not revealed to participant or experimenter. Order of treatment is randomized and counterbalanced.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Slow wave amplitude</measure>
    <time_frame>Slow Wave Amplitude will be assessed during the night of sleep (defined as 8 hours). The dependent measure for the statistical test will be slow wave amplitude expressed per minute of stage N3 sleep for the study night.</time_frame>
    <description>Amplitude of slow waves of sleep</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Slow wave duration</measure>
    <time_frame>Slow Wave Duration will be assessed in minutes for the night of sleep (defined as 8 hours). The dependent measure for the statistical test will be the duration (in minutes) of slow wave stage N3 sleep for the study night.</time_frame>
    <description>Duration of slow wave period in sleep</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Sleep Disturbance</condition>
  <condition>Insomnia</condition>
  <arm_group>
    <arm_group_label>Open-Loop</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In this arm of this repeated measures (within subjects) design, the participants receive electrical neuromodulation (TES) that is not synchronized to their slow waves of sleep. The Transcranial Electrical Stimulation (TES) is 2 mA applied in 100 ms pulses at 0.75 Hz.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Closed-Loop</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this arm of this repeated measures (within subjects) design, the participants receive electrical neuromodulation (TES) that is synchronized to their slow waves of sleep. The Transcranial Electrical Stimulation (TES) is 2 mA applied in 100 ms pulses at 0.75 Hz.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Transcranial Electrical Neuromodulation (TES)</intervention_name>
    <description>TES phase-aligned with slow waves or not</description>
    <arm_group_label>Closed-Loop</arm_group_label>
    <arm_group_label>Open-Loop</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy adults&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  persons with epilepsy&#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>
  <overall_contact>
    <last_name>Don M Tucker, PhD</last_name>
    <phone>541-653-8266</phone>
    <email>don.tucker@belco.tech</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Phan Luu, PhD</last_name>
    <phone>541-653-8266</phone>
    <email>phan.luu@belco.tech</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Brain Electrophysiology Laboratory Company</name>
      <address>
        <city>Eugene</city>
        <state>Oregon</state>
        <zip>97405</zip>
        <country>United States</country>
      </address>
    </facility>
    <contact>
      <last_name>Don M Tucker, PhD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 8, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>November 21, 2018</last_update_submitted>
  <last_update_submitted_qc>November 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brain Electrophysiology Laboratory Company</investigator_affiliation>
    <investigator_full_name>Don M. Tucker</investigator_full_name>
    <investigator_title>CEO, Senior Scientist</investigator_title>
  </responsible_party>
  <keyword>transcranial electrical stimulation</keyword>
  <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>


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/NCT03751982
org study id: 1R44MH115955
nct id: NCT03751982
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Compare closed-loop with open-loop application of TES to enhance slow waves of sleep.
Note: FDA has determined that TES with the stimulus parameters as specified for this trial
      presents no significant risk, so that FDA clearance is not required.

      Several findings suggest that Transcranial Electrical Stimulation (TES) may be particularly
      effective if it is aligned with ongoing brain activity. One condition of the present research
      is an open-loop design, in which TES pulses (0.75 Hz pulses; 2.0 mA) are presented during
      slow wave sleep. The other condition is a closed-loop design, using identical pulses, but
      these will be phase aligned with the slow waves of sleep, measured by the
      electroencephalogram (EEG). The hypothesis is that closed-loop TES will be more effective in
      enhancing the amplitude and duration of slow wave sleep than open-loop TES.
allocation: Randomized
intervention model: Single Group Assignment
intervention model description: Within subjects comparison of two effective treatments. Order of treatment is randomized and counterbalanced.
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: The phase alignment of the treatment is set in software and not revealed to participant or experimenter. Order of treatment is randomized and counterbalanced.
measure: Slow wave amplitude
time frame: Slow Wave Amplitude will be assessed during the night of sleep (defined as 8 hours). The dependent measure for the statistical test will be slow wave amplitude expressed per minute of stage N3 sleep for the study night.
description: Amplitude of slow waves of sleep
measure: Slow wave duration
time frame: Slow Wave Duration will be assessed in minutes for the night of sleep (defined as 8 hours). The dependent measure for the statistical test will be the duration (in minutes) of slow wave stage N3 sleep for the study night.
description: Duration of slow wave period in sleep
arm group label: Open-Loop
arm group type: Active Comparator
description: In this arm of this repeated measures (within subjects) design, the participants receive electrical neuromodulation (TES) that is not synchronized to their slow waves of sleep. The Transcranial Electrical Stimulation (TES) is 2 mA applied in 100 ms pulses at 0.75 Hz.
arm group label: Closed-Loop
arm group type: Experimental
description: In this arm of this repeated measures (within subjects) design, the participants receive electrical neuromodulation (TES) that is synchronized to their slow waves of sleep. The Transcranial Electrical Stimulation (TES) is 2 mA applied in 100 ms pulses at 0.75 Hz.
intervention type: Device
intervention name: Transcranial Electrical Neuromodulation (TES)
description: TES phase-aligned with slow waves or not
arm group label: Closed-Loop
arm group label: Open-Loop
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Don M Tucker, PhD
phone: 541-653-8266
email: don.tucker@belco.tech
last name: Phan Luu, PhD
phone: 541-653-8266
email: phan.luu@belco.tech
facility: 
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Brain Electrophysiology Laboratory Company
investigator full name: Don M. Tucker
investigator title: CEO, Senior Scientist
mesh term: Dyssomnias
mesh term: Parasomnias
sharing ipd: No