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/NCT05970276</url>
    </required_header>
    <id_info>
      <org_study_id>HSHEALTHY</org_study_id>
      <nct_id>NCT05970276</nct_id>
    </id_info>
    <brief_title>Non-Invasive At-Home Sleep Therapy System</brief_title>
    <official_title>Non-Invasive At-Home Sleep Therapy System</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>Yes</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>
        The goal of this clinical trial is to learn about the ability of non-invasive brain&#xD;
        stimulation during sleep to enhance people's deep sleep and its potential benefit on memory&#xD;
        in healthy adults via home use sleep therapy device (SleepWISP). Participants will be asked&#xD;
        to wear non-invasive and painless devices that record their brain activity during sleep. The&#xD;
        clinical trial aims to answer the following main questions:&#xD;
  &#xD;
          1. Whether the non-invasive transcranial electrical stimulation (TES) delivered by&#xD;
             SleepWISP could provide short-term enhancement of deep sleep in a single night in the&#xD;
             target population.&#xD;
  &#xD;
          2. Whether TES delivered by SleepWISP could improve sleep quality.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The purpose of the present research is to evaluate the ability of non-invasive transcranial&#xD;
        electrical stimulation (TES) during slow-wave sleep (SWS) to enhance this stage of sleep. It&#xD;
        has been demonstrated, in a pilot study, that TES can acutely (i.e., immediately after TES)&#xD;
        increase SWS duration. In the present proposal, the study aim to replicate and extend the&#xD;
        pilot findings. More specifically, it is proposed to conduct a sleep study using the Brain&#xD;
        Electrophysiology Laboratory (BEL) company's Sleep WISP device (described in detail below).&#xD;
        The Sleep WISP device is made up of three components: 1) 16-channel EEG amplifier with&#xD;
        transcranial electrical stimulation (TES) capabilities, 2) a 16-channel EEG headband and 3) a&#xD;
        small portable computer.&#xD;
  &#xD;
        All participants will be provided a Sleep WISP device. Participation in the study requires&#xD;
        that participants use the Sleep WISP when they sleep. As participants sleep, their sleep EEG&#xD;
        will be measured and automatically scored by the computer to determine stage of sleep. When&#xD;
        SWS is detected, low-level current (.5-1 mA total) will be applied through pre-set electrodes&#xD;
        (four on the forehead and four at base of back of head). These electrodes were used in our&#xD;
        pilot study, showing that current applied through these electrodes during SWS is able to&#xD;
        increase total SWS sleep duration.&#xD;
  &#xD;
        The study involves up to three nights of sleep. All sleep session will be at home. The first&#xD;
        session is a baseline/acclimation session. In the first session, participants will use the&#xD;
        Sleep WISP device to passively record sleep EEG (no TES) as baseline. The second session is&#xD;
        performed the night following the baseline session with randomized experiment condition&#xD;
        (either placebo or active TES session). Participants will be blinded for what condition they&#xD;
        receive. The final session will occur one week after the second session to receive the&#xD;
        opposite experiment condition to the second session.&#xD;
  &#xD;
        In our previous TES study of SWS enhancement in the BEL lab, the investigators were able to&#xD;
        show that SWS can be enhanced immediately (short-term/acute) after TES. The proposed new&#xD;
        study will extend the previous pilot in-lab study results by using Sleep WISP device at home,&#xD;
        which will allow us to support home EEG sleep monitoring and acute sleep therapy.&#xD;
  &#xD;
        Aim 1: The study aims to replicate our previous in-lab study (acute/short-term enhancement of&#xD;
        SWS) with Sleep WISP device at home for deep sleep enhance.&#xD;
  &#xD;
        Aim 2: The study aims to investigate any change on sleep quality associated with TES sleep&#xD;
        therapy delivered by Sleep WISP device.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">February 9, 2023</start_date>
    <completion_date type="Anticipated">October 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 31, 2023</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>
      <intervention_model_description>All participants receive same amount of TES stimulations, but in randomized order (stimulation either on the second night or the last night).</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>All participants receive same amount of TES stimulations over the course of the study, but they are blind to which night they receive the stimulation.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Nocturnal duration of deep sleep assessed in minutes</measure>
      <time_frame>Measured during the nights of sleep (typically 8 hours) for up to three nights.</time_frame>
      <description>Duration in minutes of N3 sleep</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Nocturnal sleep quality assessed by Pittsburgh Sleep Quality Index (PSQI)</measure>
      <time_frame>Measured after each night of sleep in the following morning for up to three nights.</time_frame>
      <description>Measured by the Pittsburgh Sleep Quality Index (PSQI). The PSQI score can range from 0 to 21 with higher scores indicating worse sleep quality.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Sleep</condition>
    <condition>Sleep Duration</condition>
    <condition>Sleep Quality</condition>
    <arm_group>
      <arm_group_label>Deep Sleep Enhancement 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>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Deep Sleep (N3) Enhancement with TES</intervention_name>
      <description>As participants sleep, their sleep EEG will be measured and automatically scored by the computer to determine stage of sleep. When slow wave sleep is detected, low-level current (.5-1 mA total) will be applied through pre-set electrodes.</description>
      <arm_group_label>Deep Sleep Enhancement with TES</arm_group_label>
      <other_name>SleepWISP TES</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Normally aging adults between the ages of 22-85&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  History of seizures&#xD;
  &#xD;
            -  History of epilepsy&#xD;
  &#xD;
            -  History of brain injury or trauma (including neurosurgery)&#xD;
  &#xD;
            -  History or presence of significant neurological disease such as Parkinson&#xD;
  &#xD;
            -  History of Electroconvulsive Therapy (ECT)&#xD;
  &#xD;
            -  Presence of severe insomnia&#xD;
  &#xD;
            -  Presence of sleep apnea&#xD;
  &#xD;
            -  Presence of severe anxiety or depression&#xD;
  &#xD;
            -  Taking medications that may affect the EEG&#xD;
  &#xD;
            -  History of stroke&#xD;
  &#xD;
            -  Sensitivity or allergy to lidocaine or silver&#xD;
  &#xD;
            -  Presence of active suicidal ideation&#xD;
  &#xD;
            -  Presence of metal in head or implants or medication infusion device&#xD;
  &#xD;
            -  Pregnancy&#xD;
  &#xD;
            -  Adverse reaction to TMS&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>22 Years</minimum_age>
      <maximum_age>85 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@bel.company</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Phan Luu, PhD</last_name>
      <phone>541-653-9797</phone>
      <email>phan.luu@bel.company</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Brain Electrophysiology Laboratory Company</name>
        <address>
          <city>Eugene</city>
          <state>Oregon</state>
          <zip>97403</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Shijing Zhou, M.S.</last_name>
        <phone>541-579-6918</phone>
        <email>shijing.zhou@bel.company</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 14, 2023</study_first_submitted>
    <study_first_submitted_qc>July 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</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>
  
  
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/NCT05970276
  org study id: HSHEALTHY
  nct id: NCT05970276
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  is us export: No
  The goal of this clinical trial is to learn about the ability of non-invasive brain
        stimulation during sleep to enhance people's deep sleep and its potential benefit on memory
        in healthy adults via home use sleep therapy device (SleepWISP). Participants will be asked
        to wear non-invasive and painless devices that record their brain activity during sleep. The
        clinical trial aims to answer the following main questions:
  
          1. Whether the non-invasive transcranial electrical stimulation (TES) delivered by
             SleepWISP could provide short-term enhancement of deep sleep in a single night in the
             target population.
  
          2. Whether TES delivered by SleepWISP could improve sleep quality.
  The purpose of the present research is to evaluate the ability of non-invasive transcranial
        electrical stimulation (TES) during slow-wave sleep (SWS) to enhance this stage of sleep. It
        has been demonstrated, in a pilot study, that TES can acutely (i.e., immediately after TES)
        increase SWS duration. In the present proposal, the study aim to replicate and extend the
        pilot findings. More specifically, it is proposed to conduct a sleep study using the Brain
        Electrophysiology Laboratory (BEL) company's Sleep WISP device (described in detail below).
        The Sleep WISP device is made up of three components: 1) 16-channel EEG amplifier with
        transcranial electrical stimulation (TES) capabilities, 2) a 16-channel EEG headband and 3) a
        small portable computer.
  
        All participants will be provided a Sleep WISP device. Participation in the study requires
        that participants use the Sleep WISP when they sleep. As participants sleep, their sleep EEG
        will be measured and automatically scored by the computer to determine stage of sleep. When
        SWS is detected, low-level current (.5-1 mA total) will be applied through pre-set electrodes
        (four on the forehead and four at base of back of head). These electrodes were used in our
        pilot study, showing that current applied through these electrodes during SWS is able to
        increase total SWS sleep duration.
  
        The study involves up to three nights of sleep. All sleep session will be at home. The first
        session is a baseline/acclimation session. In the first session, participants will use the
        Sleep WISP device to passively record sleep EEG (no TES) as baseline. The second session is
        performed the night following the baseline session with randomized experiment condition
        (either placebo or active TES session). Participants will be blinded for what condition they
        receive. The final session will occur one week after the second session to receive the
        opposite experiment condition to the second session.
  
        In our previous TES study of SWS enhancement in the BEL lab, the investigators were able to
        show that SWS can be enhanced immediately (short-term/acute) after TES. The proposed new
        study will extend the previous pilot in-lab study results by using Sleep WISP device at home,
        which will allow us to support home EEG sleep monitoring and acute sleep therapy.
  
        Aim 1: The study aims to replicate our previous in-lab study (acute/short-term enhancement of
        SWS) with Sleep WISP device at home for deep sleep enhance.
  
        Aim 2: The study aims to investigate any change on sleep quality associated with TES sleep
        therapy delivered by Sleep WISP device.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: All participants receive same amount of TES stimulations, but in randomized order (stimulation either on the second night or the last night).
  primary purpose: Treatment
  masking: None (Open Label)
  masking description: All participants receive same amount of TES stimulations over the course of the study, but they are blind to which night they receive the stimulation.
  measure: Nocturnal duration of deep sleep assessed in minutes
  time frame: Measured during the nights of sleep (typically 8 hours) for up to three nights.
  description: Duration in minutes of N3 sleep
  measure: Nocturnal sleep quality assessed by Pittsburgh Sleep Quality Index (PSQI)
  time frame: Measured after each night of sleep in the following morning for up to three nights.
  description: Measured by the Pittsburgh Sleep Quality Index (PSQI). The PSQI score can range from 0 to 21 with higher scores indicating worse sleep quality.
  arm group label: Deep Sleep Enhancement 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.
  intervention type: Device
  intervention name: Deep Sleep (N3) Enhancement with TES
  description: As participants sleep, their sleep EEG will be measured and automatically scored by the computer to determine stage of sleep. When slow wave sleep is detected, low-level current (.5-1 mA total) will be applied through pre-set electrodes.
  arm group label: Deep Sleep Enhancement with TES
  other name: SleepWISP TES
  criteria: 
  gender: All
  minimum age: 22 Years
  maximum age: 85 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Don M Tucker, PhD
  phone: 541-653-8266
  email: don.tucker@bel.company
  last name: Phan Luu, PhD
  phone: 541-653-9797
  email: phan.luu@bel.company
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Sponsor
  sharing ipd: No