<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/NCT03828656</url>
  </required_header>
  <id_info>
    <org_study_id>NW101003</org_study_id>
    <nct_id>NCT03828656</nct_id>
  </id_info>
  <brief_title>NightWare Open Enrollment Study</brief_title>
  <acronym>NWOES</acronym>
  <official_title>NightWare Open Enrollment Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NightWare</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>RationalPsych</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Center for International Emergency Medical Services</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>NightWare</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>
      This study will provide measures of safety and efficacy of the NightWare digital therapeutic&#xD;
      system (iPhone + Apple watch + proprietary application) for the treatment of nightmare&#xD;
      disorder associated with post-traumatic stress disorder (PTSD)-related sleep disturbance and&#xD;
      the impact of improved sleep with the NightWare digital therapeutic system. The investigators&#xD;
      hypothesize that the NightWare digital therapeutic system will significantly improve sleep&#xD;
      quality in participants with PTSD-Related nightmares and poor sleep quality.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Nightmares are a common problem affecting 2-8% of the general population and a higher&#xD;
      proportion of clinical populations. The negative consequences of untreated nightmares are&#xD;
      significant and include impaired quality of life, sleep deprivation (often resulting in an&#xD;
      increased intensity of nightmares), insomnia, daytime sleepiness, and fatigue. Untreated&#xD;
      nightmares can also exacerbate the symptoms of underlying psychological dysfunction in people&#xD;
      with depression and anxiety, leading to poor occupational and or social functioning.&#xD;
      Nightmares can be idiopathic or associated with the use (or withdrawal) of certain&#xD;
      medications or substances or associated with disorders including PTSD.&#xD;
&#xD;
      NightWare (Minneapolis, MN) has developed a novel approach to the treatment of nightmares.&#xD;
      Through the use of a smartwatch-based application that senses physiologic parameters, the&#xD;
      participant is aroused from sleep (without awakening the participant) so that the nightmare&#xD;
      is interrupted prior to reaching a threshold of severity in which the participant would&#xD;
      awaken in distress. Seconds later the participant returns to sleep without having experienced&#xD;
      a nightmare. This approach avoids risk from pharmacological treatment, avoids exacerbation of&#xD;
      symptoms from image rehearsal therapy and allows for a simple method with easily achieved&#xD;
      adherence compared to existing treatments.&#xD;
&#xD;
      The NightWare digital therapeutic system consists of a proprietary software application&#xD;
      installed on a smartwatch. The application has been effective in focus groups when used on&#xD;
      both Apple smartwatches and Motorola smartwatches. For the purposes of this study, the&#xD;
      investigators will be using only the Apple (Cupertino, CA) 3rd generation smartwatch and the&#xD;
      Apple iPhone. The NightWare application uses physiological markers obtained via the&#xD;
      smartwatch to determine by proprietary algorithm whether a participant is in the early stages&#xD;
      of a nightmare, but has not yet awoken in distress. As directed by the algorithm, the&#xD;
      smartwatch then applies varying degrees of vibratory stimulation to the wrist over variable&#xD;
      lengths of time with the intention of arousing the participant from sleep without eliciting&#xD;
      an awakening.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Anticipated">February 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">February 1, 2022</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 global score on the Pittsburgh Sleep Quality Index (PSQI) from Day 0 to each subsequent 28 day evaluation period</measure>
    <time_frame>0-730 days</time_frame>
    <description>The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate seven &quot;component&quot; scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality. This outcome is the difference between the global score on the Pittsburgh Sleep Quality Index (PSQI) score at baseline (Day 0) and average global PSQI score across the post-treatment initiation assessments (Days 14, 28 and every 28 days after that).</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">400</enrollment>
  <condition>PostTraumatic Stress Disorder</condition>
  <condition>Sleep Disorder</condition>
  <condition>Stress Disorder</condition>
  <condition>Sleep Initiation and Maintenance Disorders</condition>
  <condition>Combat Disorders</condition>
  <condition>Nightmares Associated With Chronic Post-Traumatic Stress Disorder</condition>
  <condition>Nightmare</condition>
  <condition>Nightmares, REM-Sleep Type</condition>
  <arm_group>
    <arm_group_label>Open Label Treatment Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Open-label Intervention with the NightWare Therapeutic System every night.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>NightWare Therapeutic System</intervention_name>
    <description>A wearable digital therapeutic system that will measure physiologic data when worn during sleep to deliver a mild vibration via the watch to elicit arousal thereby disrupting nightmares. This detection and stimulation sequence will be performed according to NightWare's proprietary algorithm.</description>
    <arm_group_label>Open Label Treatment Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        New to NightWare&#xD;
&#xD;
          -  Self report of diagnosis with PTSD&#xD;
&#xD;
          -  Self-report of PTSD-related repetitive nightmares contributing to disrupted sleep.&#xD;
&#xD;
          -  Equal to or older than 18 years of age.&#xD;
&#xD;
          -  Proficient in both reading and writing in the English language.&#xD;
&#xD;
          -  Pittsburgh Sleep Quality Index (PSQI) score equal to or greater than 10.&#xD;
&#xD;
          -  ESS: On question #8 any score above &quot;0&quot; will prompt an additional question:&#xD;
&#xD;
          -  Do you drive (&quot;get behind the wheel&quot;) when you are drowsy?&#xD;
&#xD;
          -  Answer must be &quot;No&quot; to be enrolled in the study for safety.&#xD;
&#xD;
          -  Participant owns or has access to devices appropriate for participation in the study&#xD;
             including compatible Apple Watch and Apple iPhone.&#xD;
&#xD;
          -  Wireless Internet and two power outlets where they sleep.&#xD;
&#xD;
        OR&#xD;
&#xD;
        Current NightWare user - Is a participant in current NightWare consumer preference study or&#xD;
        has successfully completed any NightWare study protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        New to NightWare&#xD;
&#xD;
          -  Circadian rhythm disruption on a regular basis (shift-work)&#xD;
&#xD;
          -  Concurrent presence of prohibited diagnoses&#xD;
&#xD;
          -  Known diagnosis of OSA&#xD;
&#xD;
          -  Diagnosis of an active disorder of arousal from non-rapid eye movement sleep&#xD;
&#xD;
          -  Diagnosis of rapid eye movement sleep behavior disorder&#xD;
&#xD;
          -  Diagnosis of narcolepsy&#xD;
&#xD;
          -  Diagnosis of dementia&#xD;
&#xD;
          -  Uncontrolled atrial fibrillation&#xD;
&#xD;
          -  Use of Alcohol or Drugs as specified:&#xD;
&#xD;
          -  Alcohol Use Disorders Inventory Test (AUDIT) (score of 8 or higher)&#xD;
&#xD;
          -  Drug Abuse Screening Test-10 (DAST-10) (score greater than 2)&#xD;
&#xD;
          -  Suspicion of nightmares being secondary to substance abuse or withdrawal&#xD;
&#xD;
          -  Previous or foreseeable legal proceedings involving nightmares or trauma&#xD;
&#xD;
          -  Nocturia that causes awakening from sleep&#xD;
&#xD;
          -  Known sleep walking&#xD;
&#xD;
          -  Acting out of dreams PRIOR to PTSD trauma&#xD;
&#xD;
          -  Willingness not to use any other application which collects heart rate data on the&#xD;
             phone and watch that is used for NightWare.&#xD;
&#xD;
        OR&#xD;
&#xD;
        Current NightWare User&#xD;
&#xD;
        - No known adverse reaction to the use of the NightWare system.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel R Karlin, MD MA</last_name>
    <role>Principal Investigator</role>
    <affiliation>RationalPsych</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>RationalPsych</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10461</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>January 31, 2019</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>March 3, 2021</last_update_submitted>
  <last_update_submitted_qc>March 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 4, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>PTSD</keyword>
  <keyword>Nightmare Disorder</keyword>
  <keyword>Post-traumatic stress disorder</keyword>
  <keyword>Veteran</keyword>
  <keyword>Digital therapeutic</keyword>
  <keyword>Digital medicine</keyword>
  <keyword>Nightmares</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Wake Disorders</mesh_term>
    <mesh_term>Sleep Initiation and Maintenance Disorders</mesh_term>
    <mesh_term>Stress Disorders, Traumatic</mesh_term>
    <mesh_term>Stress Disorders, Post-Traumatic</mesh_term>
    <mesh_term>Combat Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</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/NCT03828656
org study id: NW101003
nct id: NCT03828656
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
This study will provide measures of safety and efficacy of the NightWare digital therapeutic
      system (iPhone + Apple watch + proprietary application) for the treatment of nightmare
      disorder associated with post-traumatic stress disorder (PTSD)-related sleep disturbance and
      the impact of improved sleep with the NightWare digital therapeutic system. The investigators
      hypothesize that the NightWare digital therapeutic system will significantly improve sleep
      quality in participants with PTSD-Related nightmares and poor sleep quality.
Nightmares are a common problem affecting 2-8% of the general population and a higher
      proportion of clinical populations. The negative consequences of untreated nightmares are
      significant and include impaired quality of life, sleep deprivation (often resulting in an
      increased intensity of nightmares), insomnia, daytime sleepiness, and fatigue. Untreated
      nightmares can also exacerbate the symptoms of underlying psychological dysfunction in people
      with depression and anxiety, leading to poor occupational and or social functioning.
      Nightmares can be idiopathic or associated with the use (or withdrawal) of certain
      medications or substances or associated with disorders including PTSD.

      NightWare (Minneapolis, MN) has developed a novel approach to the treatment of nightmares.
      Through the use of a smartwatch-based application that senses physiologic parameters, the
      participant is aroused from sleep (without awakening the participant) so that the nightmare
      is interrupted prior to reaching a threshold of severity in which the participant would
      awaken in distress. Seconds later the participant returns to sleep without having experienced
      a nightmare. This approach avoids risk from pharmacological treatment, avoids exacerbation of
      symptoms from image rehearsal therapy and allows for a simple method with easily achieved
      adherence compared to existing treatments.

      The NightWare digital therapeutic system consists of a proprietary software application
      installed on a smartwatch. The application has been effective in focus groups when used on
      both Apple smartwatches and Motorola smartwatches. For the purposes of this study, the
      investigators will be using only the Apple (Cupertino, CA) 3rd generation smartwatch and the
      Apple iPhone. The NightWare application uses physiological markers obtained via the
      smartwatch to determine by proprietary algorithm whether a participant is in the early stages
      of a nightmare, but has not yet awoken in distress. As directed by the algorithm, the
      smartwatch then applies varying degrees of vibratory stimulation to the wrist over variable
      lengths of time with the intention of arousing the participant from sleep without eliciting
      an awakening.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in global score on the Pittsburgh Sleep Quality Index (PSQI) from Day 0 to each subsequent 28 day evaluation period
time frame: 0-730 days
description: The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality. This outcome is the difference between the global score on the Pittsburgh Sleep Quality Index (PSQI) score at baseline (Day 0) and average global PSQI score across the post-treatment initiation assessments (Days 14, 28 and every 28 days after that).
arm group label: Open Label Treatment Arm
arm group type: Experimental
description: Open-label Intervention with the NightWare Therapeutic System every night.
intervention type: Device
intervention name: NightWare Therapeutic System
description: A wearable digital therapeutic system that will measure physiologic data when worn during sleep to deliver a mild vibration via the watch to elicit arousal thereby disrupting nightmares. This detection and stimulation sequence will be performed according to NightWare's proprietary algorithm.
arm group label: Open Label Treatment Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Daniel R Karlin, MD MA
role: Principal Investigator
affiliation: RationalPsych
facility: 
country: United States
responsible party type: Sponsor
mesh term: Sleep Wake Disorders
mesh term: Sleep Initiation and Maintenance Disorders
mesh term: Stress Disorders, Traumatic
mesh term: Stress Disorders, Post-Traumatic
mesh term: Combat Disorders
sharing ipd: Yes