<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/NCT04461769</url>
  </required_header>
  <id_info>
    <org_study_id>R44MH115955</org_study_id>
    <nct_id>NCT04461769</nct_id>
  </id_info>
  <brief_title>Electrical Synchronization of Slow Oscillations to Enhance Deep Sleep</brief_title>
  <acronym>ESSOTEDS</acronym>
  <official_title>Electrical Synchronization of Slow Oscillations to Enhance Deep Sleep</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>
      This study applied slowly oscillating (0.5 hz) transcranial electrical stimulation (TES;&#xD;
      frontopolar and lateral frontal electrodes versus mastoid and occipital electrode returns) to&#xD;
      synchronize the endogenous slow oscillations (SOs) of deep sleep (N3 or stage 3 Non-REM). A&#xD;
      double-blind placebo control provided no stimulation. The primary endpoint was duration of N3&#xD;
      sleep during the night. Thirteen normal adults completed the study (before the study was&#xD;
      terminated because of COVID-19), and usable data were obtained from ten. The synchronizing&#xD;
      stimulation resulted in significantly longer N3 sleep compared to placebo.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Previous studies have demonstrated successful synchronization of SOs with slow TES pulses.&#xD;
      However, the stimulation in those studies used electrodes in dorsolateral frontal areas (F3,&#xD;
      F4 versus contralateral mastoids), consistent with the assumption that human SOs emanate from&#xD;
      frontal neocortex. In the present study, we hypothesized that transcranial electrical&#xD;
      stimulation (TES) could be applied to frontopolar and inferior frontal head sites in order to&#xD;
      synchronize the limbic sources of SOs specifically and thereby enhance the duration of N3&#xD;
      sleep. Furthermore, based on our computational modeling with this more optimal targeting of&#xD;
      the limbic sites, we hypothesized that we could use lower TES current levels (0.5 mA versus 1&#xD;
      or 2 mA in previous studies) that would be unlikely to disrupt sleep and that may still be&#xD;
      successful in synchronizing SOs to enhance the adaptive neurophysiology of deep sleep.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2019</start_date>
  <completion_date type="Actual">May 30, 2020</completion_date>
  <primary_completion_date type="Actual">May 30, 2020</primary_completion_date>
  <phase>Early Phase 1</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>First night adaptation sleep; second and third nights (one week apart) stimulation or placebo control (order randomized).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
    <masking_description>Participants were blind to which night was stimulation. Experimenters were blinded until the participant was asleep, when they opened an email that specified delivery of stimulation or sham.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>N3 Duration</measure>
    <time_frame>Measured during the night of sleep (typically 8 hours)</time_frame>
    <description>Duration in minutes of N3 sleep</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>N3 Percentage</measure>
    <time_frame>Measured during the night of sleep (typically 8 hours)</time_frame>
    <description>Percentage of the night's sleep spent in N3</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Sleep</condition>
  <condition>Sleep Hygiene</condition>
  <arm_group>
    <arm_group_label>Slow Oscillation Synchronization with TES</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Transcranial Electrical Stimulation, 0.5 Hz sine wave, 0.5 mA, between frontal (frontopolar and inferior lateral frontal) and posterior (mastoid and occipital) electrodes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham Control</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>No current delivered.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Transcranial Electrical Stimulation</intervention_name>
    <description>Oscillating electrical current</description>
    <arm_group_label>Sham Control</arm_group_label>
    <arm_group_label>Slow Oscillation Synchronization with TES</arm_group_label>
    <other_name>Sleep WISP (Wireless Interface Sensor Pod)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of seizures&#xD;
&#xD;
          -  epilepsy&#xD;
&#xD;
          -  brain trauma or injury&#xD;
&#xD;
          -  insomnia&#xD;
&#xD;
          -  sleep apnea&#xD;
&#xD;
          -  medications that may affect the EEG.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Brain Electrophysiology Laboratory Company</name>
      <address>
        <city>Eugene</city>
        <state>Oregon</state>
        <zip>97405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>July 2, 2020</last_update_submitted>
  <last_update_submitted_qc>July 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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/NCT04461769
org study id: R44MH115955
nct id: NCT04461769
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study applied slowly oscillating (0.5 hz) transcranial electrical stimulation (TES;
      frontopolar and lateral frontal electrodes versus mastoid and occipital electrode returns) to
      synchronize the endogenous slow oscillations (SOs) of deep sleep (N3 or stage 3 Non-REM). A
      double-blind placebo control provided no stimulation. The primary endpoint was duration of N3
      sleep during the night. Thirteen normal adults completed the study (before the study was
      terminated because of COVID-19), and usable data were obtained from ten. The synchronizing
      stimulation resulted in significantly longer N3 sleep compared to placebo.
Previous studies have demonstrated successful synchronization of SOs with slow TES pulses.
      However, the stimulation in those studies used electrodes in dorsolateral frontal areas (F3,
      F4 versus contralateral mastoids), consistent with the assumption that human SOs emanate from
      frontal neocortex. In the present study, we hypothesized that transcranial electrical
      stimulation (TES) could be applied to frontopolar and inferior frontal head sites in order to
      synchronize the limbic sources of SOs specifically and thereby enhance the duration of N3
      sleep. Furthermore, based on our computational modeling with this more optimal targeting of
      the limbic sites, we hypothesized that we could use lower TES current levels (0.5 mA versus 1
      or 2 mA in previous studies) that would be unlikely to disrupt sleep and that may still be
      successful in synchronizing SOs to enhance the adaptive neurophysiology of deep sleep.
allocation: Randomized
intervention model: Single Group Assignment
intervention model description: First night adaptation sleep; second and third nights (one week apart) stimulation or placebo control (order randomized).
primary purpose: Treatment
masking: Double (Participant, Care Provider)
masking description: Participants were blind to which night was stimulation. Experimenters were blinded until the participant was asleep, when they opened an email that specified delivery of stimulation or sham.
measure: N3 Duration
time frame: Measured during the night of sleep (typically 8 hours)
description: Duration in minutes of N3 sleep
measure: N3 Percentage
time frame: Measured during the night of sleep (typically 8 hours)
description: Percentage of the night's sleep spent in N3
arm group label: Slow Oscillation Synchronization with TES
arm group type: Experimental
description: Transcranial Electrical Stimulation, 0.5 Hz sine wave, 0.5 mA, between frontal (frontopolar and inferior lateral frontal) and posterior (mastoid and occipital) electrodes.
arm group label: Sham Control
arm group type: Sham Comparator
description: No current delivered.
intervention type: Device
intervention name: Transcranial Electrical Stimulation
description: Oscillating electrical current
arm group label: Sham Control
arm group label: Slow Oscillation Synchronization with TES
other name: Sleep WISP (Wireless Interface Sensor Pod)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No