<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/NCT02236845</url>
  </required_header>
  <id_info>
    <org_study_id>LM002</org_study_id>
    <nct_id>NCT02236845</nct_id>
  </id_info>
  <brief_title>Pilot Study to Clinical Evaluate Lacrima Medical Device in Insomnia Patients</brief_title>
  <official_title>Pilot, Randomized, Cross-over Study to Evaluate Safety and Clinical Effect of Lacrima Medical Device in Patients With Chronic Insomnia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lacrima Medical LTD</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lacrima Medical LTD</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study will assess the safety, tolerability and feasibility of Lacrima investigational&#xD;
      medical device vs. sham device in adult patients with chronic Insomnia&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">July 2016</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of adverse events</measure>
    <time_frame>Up to 37 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in sleep latency time based on sleep actigraph</measure>
    <time_frame>28 days</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in sleep latency time based on sleep diaries</measure>
    <time_frame>28 days</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Chronic Insomnia</condition>
  <arm_group>
    <arm_group_label>Lacrima medical active device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Lacrima medical sham device</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Lacrima Medical Device and sham comparator</intervention_name>
    <arm_group_label>Lacrima medical active device</arm_group_label>
    <arm_group_label>Lacrima medical sham device</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Main Inclusion Criteria:&#xD;
&#xD;
          1. Adult subjects, 18 years of age and older at screening&#xD;
&#xD;
          2. Diagnosis of primary insomnia based on International Classification of Sleep&#xD;
             Disorders, revision no 2&#xD;
&#xD;
          3. Total score of Pittsburgh Sleep Quality questionnaire is &gt; 5&#xD;
&#xD;
          4. Latency to persistent sleep is &gt; 30 minutes based on Pittsburgh questionnaire&#xD;
&#xD;
          5. Able to understand and provide written informed consent&#xD;
&#xD;
        Main Exclusion Criteria:&#xD;
&#xD;
          1. Patients using any pharmacological treatments for insomnia for 14 days&#xD;
&#xD;
          2. Patients currently using stimulants drugs 7 days&#xD;
&#xD;
          3. Patients currently using antidepressants causing sleepiness&#xD;
&#xD;
          4. Patients who are unable to commit to avoid consumption alcohol during the study&#xD;
&#xD;
          5. Patients who are unable to commit to avoid consumption caffeine after 12 pm&#xD;
&#xD;
          6. Patients who have a clinical significant or unstable medical or surgical condition&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Rambam Health Care Campus</name>
      <address>
        <city>Haifa</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>September 6, 2014</study_first_submitted>
  <study_first_submitted_qc>September 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2014</study_first_posted>
  <last_update_submitted>August 14, 2016</last_update_submitted>
  <last_update_submitted_qc>August 14, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 16, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Insomnia, medical device, sleep latency</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Initiation and Maintenance Disorders</mesh_term>
  </condition_browse>
  <!-- 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/NCT02236845
org study id: LM002
nct id: NCT02236845
lead sponsor: 
has dmc: No
The study will assess the safety, tolerability and feasibility of Lacrima investigational
      medical device vs. sham device in adult patients with chronic Insomnia
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Rate of adverse events
time frame: Up to 37 days
measure: Change in sleep latency time based on sleep actigraph
time frame: 28 days
measure: Change in sleep latency time based on sleep diaries
time frame: 28 days
arm group label: Lacrima medical active device
arm group type: Experimental
arm group label: Lacrima medical sham device
arm group type: Sham Comparator
intervention type: Device
intervention name: Lacrima Medical Device and sham comparator
arm group label: Lacrima medical active device
arm group label: Lacrima medical sham device
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Sleep Initiation and Maintenance Disorders