<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/NCT03795987</url>
  </required_header>
  <id_info>
    <org_study_id>NW101001</org_study_id>
    <nct_id>NCT03795987</nct_id>
  </id_info>
  <brief_title>Traumatic Nightmares Treated by NightWare (To Arouse Not Awaken)</brief_title>
  <acronym>TNT/NW</acronym>
  <official_title>TNT/NW: Traumatic Nightmares Treated by NightWare (To Arouse Not Awaken)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NightWare</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Minneapolis Veterans Affairs Medical Center</agency>
      <agency_class>U.S. Fed</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 preliminary estimates of safety and efficacy of the NightWare digital&#xD;
      therapeutic system (iPhone + Apple watch + proprietary application) for the treatment of&#xD;
      nightmare disorder associated with post-traumatic stress disorder (PTSD)-related sleep&#xD;
      disturbance and the impact of improved sleep with the NightWare digital therapeutic system.&#xD;
      The investigators hypothesize that the NightWare digital therapeutic system will&#xD;
      significantly improve sleep quality in participants with PTSD-Related nightmares and poor&#xD;
      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>Completed</overall_status>
  <start_date type="Actual">February 7, 2019</start_date>
  <completion_date type="Actual">August 14, 2019</completion_date>
  <primary_completion_date type="Actual">August 14, 2019</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 Day 60</measure>
    <time_frame>0-60 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 four post-treatment initiation assessments (Days 14, 30, 44 and 60).</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Stress Disorders, Post-Traumatic</condition>
  <condition>Combat Disorders</condition>
  <condition>Ptsd</condition>
  <condition>Nightmare</condition>
  <condition>Nightmares, REM-Sleep Type</condition>
  <condition>Nightmare Disorder With Associated Non-Sleep Disorder</condition>
  <arm_group>
    <arm_group_label>Open Label Treatment Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention with NightWare Therapeutic System</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;
          -  Veteran Enrolled in the Minneapolis/St. Cloud VAHCS.&#xD;
&#xD;
          -  Diagnosis of PTSD via American Psychiatric Association PTSD diagnostic criteria in the&#xD;
             fifth edition of its Diagnostic and Statistical Manual of Mental Disorders (DSM-5).&#xD;
&#xD;
          -  Equal to or older than 22 years of age.&#xD;
&#xD;
          -  Proficient in both reading and writing in the English language.&#xD;
&#xD;
          -  Pittsburgh Sleep Quality Index (PSQI) score 10 or higher.&#xD;
&#xD;
          -  Epworth Sleepiness Scale (ESS): On question #8 any score above &quot;0&quot; will prompt an&#xD;
             additional question: Do you drive (&quot;get behind the wheel&quot;) when you are drowsy? The&#xD;
             answer must be &quot;No&quot; to be enrolled in the study due to safety concerns.&#xD;
&#xD;
          -  Have repetitive nightmares contributing to disrupted sleep as reported by the patient&#xD;
&#xD;
          -  Wireless Internet and two power outlets where they sleep&#xD;
&#xD;
          -  Prazosin use; if yes, the patient may be included if tapered by prescribing provider.&#xD;
             Taper must be completed and subject must be off prazosin for 2 days prior to&#xD;
             enrollment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient Health Questionnaire-9 (PHQ-9) score greater than or equal to 20. A score of 1&#xD;
             or more on the suicide ideation item of the PHQ-9 will trigger a risk assessment.&#xD;
&#xD;
          -  Uncontrolled atrial fibrillation&#xD;
&#xD;
          -  Current use of varenicline&#xD;
&#xD;
          -  Current use of beta-blockers (unless ophthalmic solutions)&#xD;
&#xD;
          -  Current use of non-dihydropyridines&#xD;
&#xD;
          -  Current use of Prazosin for the treatment of nightmares (can include patients 2 days&#xD;
             following taper and discontinuation) This would be coordinated with the prescribing&#xD;
             provider&#xD;
&#xD;
          -  Circadian rhythm disruption on a regular basis (shift-work)&#xD;
&#xD;
          -  Known diagnosis of Obstructive Sleep Apnea&#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;
          -  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;
          -  Diagnosis or suspicion of dementia&#xD;
&#xD;
          -  Previous or foreseeable legal proceedings involving nightmares or trauma&#xD;
&#xD;
          -  Nocturia that causes awakening from sleep&#xD;
&#xD;
          -  Known sleepwalking&#xD;
&#xD;
          -  Acting out of dreams prior to PTSD trauma&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 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>Study Chair</role>
    <affiliation>NightWare</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Minneapolis VA Healthcare System</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55417</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>January 4, 2019</study_first_submitted>
  <study_first_submitted_qc>January 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 8, 2019</study_first_posted>
  <last_update_submitted>February 25, 2020</last_update_submitted>
  <last_update_submitted_qc>February 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>PTSD</keyword>
  <keyword>Nightmare</keyword>
  <keyword>Nightmare Disorder</keyword>
  <keyword>Post-traumatic stress disorder</keyword>
  <keyword>Veteran</keyword>
  <keyword>Digital therapeutic</keyword>
  <keyword>Digital medicine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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>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/NCT03795987
org study id: NW101001
nct id: NCT03795987
lead sponsor: 
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 preliminary estimates 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 Day 60
time frame: 0-60 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 four post-treatment initiation assessments (Days 14, 30, 44 and 60).
arm group label: Open Label Treatment Arm
arm group type: Experimental
description: Intervention with NightWare Therapeutic System
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: 22 Years
maximum age: N/A
healthy volunteers: No
last name: Daniel R Karlin, MD MA
role: Study Chair
affiliation: NightWare
facility: 
country: United States
responsible party type: Sponsor
mesh term: Stress Disorders, Traumatic
mesh term: Stress Disorders, Post-Traumatic
mesh term: Combat Disorders
sharing ipd: No