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/NCT06016166</url>
    </required_header>
    <id_info>
      <org_study_id>IR.SBMU.RETECH.REC.1402.099</org_study_id>
      <nct_id>NCT06016166</nct_id>
    </id_info>
    <brief_title>Eye Mask on Sleep Quality and Tear Layer Function in Patients With Dry Eye Disease</brief_title>
    <official_title>The Effects of Eye Mask on Increasing the Sleep Quality and Tear Layer Function in Patients With Dry Eye Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hamideh Sabbaghi</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Shahid Beheshti University of Medical Sciences</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This randomized clinical trial (RCT) was aimed to determine the effects of eye masking on&#xD;
        sleep quality and tear layer function in patients with dry eye disease. In this regard, a&#xD;
        total of 34 patients with dry eye disease aged between 20 to 35 years old will be&#xD;
        participated. They will be randomly divided into case and control (n=17) groups. Patients in&#xD;
        the case group will be instructed to wear the eye mask as long as two weeks and the controls&#xD;
        will be recommended to not wear it at the same time. Afterwards, the eye mask application&#xD;
        will be cross- over for the next 2 hours between the two groups. Tear layer will be&#xD;
        investigated in baseline and repeated in both follow- ups of weeks 2 and 4, either&#xD;
        quantitatively and qualitatively, by using Schirmer and TBUT tests. Furthermore, the sleep&#xD;
        quality will be checked by the PSQI test.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">December 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2024</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>Supportive Care</primary_purpose>
      <masking>Double (Care Provider, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The effect of using eye mask on tear layer functions between baseline and follow- ups of weeks 2 and 4 in patients with dry eye</measure>
      <time_frame>between baseline and follow- ups of weeks 2 and 4</time_frame>
      <description>Tear film function is measured quantitatively and qualitatively by the Schirmer (based on millimeters) and TBUT ( based on seconds) test</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The effect of using eye mask on sleep quality between baseline and follow- ups of weeks 2 and 4 in patients with dry eye</measure>
      <time_frame>between baseline and follow- ups of weeks 2 and 4</time_frame>
      <description>Sleep quality is measured by PSQI test based on the obtained score</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">34</enrollment>
    <condition>Dry Eye Disease</condition>
    <arm_group>
      <arm_group_label>Eye mask users</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The eyes of the patients will be defined as the intervention</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Non eye mask users</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>The eyes of the patients will be defined as the controls</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Eye mask</intervention_name>
      <description>The 3D eye mask with the ability to adjust for different faces and eliminate light</description>
      <arm_group_label>Eye mask users</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with dry eye disease according to the OSDI test&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with eye disease except dry eye&#xD;
  &#xD;
            -  Patients using systemic and ophthalmic drugs&#xD;
  &#xD;
            -  Patients using sleeping and sedative pills&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>35 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Hamideh Sabbaghi, PhD</last_name>
      <phone>989120285930</phone>
      <email>sabbaghi.opt@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Hamideh Sabbaghi</name>
        <address>
          <city>Tehran</city>
          <country>Iran, Islamic Republic of</country>
        </address>
      </facility>
      <contact>
        <last_name>Hamideh Sabbaghi, PhD</last_name>
        <phone>989120285930</phone>
        <email>sabbaghi.opt@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Iran, Islamic Republic of</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Shahid Beheshti University of Medical Sciences</investigator_affiliation>
      <investigator_full_name>Hamideh Sabbaghi</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dry Eye Syndromes</mesh_term>
      <mesh_term>Keratoconjunctivitis Sicca</mesh_term>
      <mesh_term>Eye Diseases</mesh_term>
    </condition_browse>
    <!-- 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/NCT06016166
  org study id: IR.SBMU.RETECH.REC.1402.099
  nct id: NCT06016166
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This randomized clinical trial (RCT) was aimed to determine the effects of eye masking on
        sleep quality and tear layer function in patients with dry eye disease. In this regard, a
        total of 34 patients with dry eye disease aged between 20 to 35 years old will be
        participated. They will be randomly divided into case and control (n=17) groups. Patients in
        the case group will be instructed to wear the eye mask as long as two weeks and the controls
        will be recommended to not wear it at the same time. Afterwards, the eye mask application
        will be cross- over for the next 2 hours between the two groups. Tear layer will be
        investigated in baseline and repeated in both follow- ups of weeks 2 and 4, either
        quantitatively and qualitatively, by using Schirmer and TBUT tests. Furthermore, the sleep
        quality will be checked by the PSQI test.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Supportive Care
  masking: Double (Care Provider, Investigator)
  measure: The effect of using eye mask on tear layer functions between baseline and follow- ups of weeks 2 and 4 in patients with dry eye
  time frame: between baseline and follow- ups of weeks 2 and 4
  description: Tear film function is measured quantitatively and qualitatively by the Schirmer (based on millimeters) and TBUT ( based on seconds) test
  measure: The effect of using eye mask on sleep quality between baseline and follow- ups of weeks 2 and 4 in patients with dry eye
  time frame: between baseline and follow- ups of weeks 2 and 4
  description: Sleep quality is measured by PSQI test based on the obtained score
  arm group label: Eye mask users
  arm group type: Experimental
  description: The eyes of the patients will be defined as the intervention
  arm group label: Non eye mask users
  arm group type: No Intervention
  description: The eyes of the patients will be defined as the controls
  intervention type: Device
  intervention name: Eye mask
  description: The 3D eye mask with the ability to adjust for different faces and eliminate light
  arm group label: Eye mask users
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 35 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Hamideh Sabbaghi, PhD
  phone: 989120285930
  email: sabbaghi.opt@gmail.com
  facility: 
  contact: 
  country: Iran, Islamic Republic of
  responsible party type: Sponsor-Investigator
  investigator affiliation: Shahid Beheshti University of Medical Sciences
  investigator full name: Hamideh Sabbaghi
  investigator title: Principal Investigator
  mesh term: Dry Eye Syndromes
  mesh term: Keratoconjunctivitis Sicca
  mesh term: Eye Diseases