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/NCT06028997</url>
    </required_header>
    <id_info>
      <org_study_id>VSN-23-086</org_study_id>
      <nct_id>NCT06028997</nct_id>
    </id_info>
    <brief_title>Behavioral and Sleep Hygiene Education With Mindfulness Intervention to Improve Sleep Regularity in Adolescents</brief_title>
    <official_title>Implementation of Behavioral and Sleep Hygiene Education With Mindfulness Intervention to Improve Sleep Regularity in Adolescents; is There a Relationship With Anxiety, Depression or Chronotype</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Solveig Magnusdottir</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Menntaskolin a Akureyri</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Akureyri Hospital</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Sleep plays a fundamental role in both mental- and physical-health, with good sleep health&#xD;
        including adequate duration and quality, appropriate timing, regularity, and absence of sleep&#xD;
        disorders. The purpose of this study is to evaluate sleep in adolescent and if brief&#xD;
        behavioral and sleep hygiene education with mindfulness intervention improves, sleep timing,&#xD;
        sleep duration, sleep quality, anxiety- and depression symptoms.&#xD;
  &#xD;
        During adolescence extensive physiological changes happen that make it easier for adolescents&#xD;
        to stay up later, that may increase the time it may take them to fall-asleep and developing&#xD;
        insomnia symptoms. At the same time psychosocial changes happen, the societal changes in the&#xD;
        last decade may even have further amplified late sleep in adolescents, with increase in&#xD;
        social media use and evening screen-time. As sleep need is not decreased and with adolescents&#xD;
        having to wake up at &quot;socially acceptable times&quot; rather than the endogenous sleep offset&#xD;
        time, sleep duration may be shortened causing chronic sleep loss and daytime sleepiness.&#xD;
        Insufficient sleep in adolescents may affect their daytime functioning, causing fatigue and&#xD;
        memory issues, affect school attendance and academic performance, affect mood, mental- and&#xD;
        physical health, cause behavioral dysfunction and has been associated with worse health&#xD;
        outcomes, adverse risk behaviors and even increase risk for accidents.This study should&#xD;
        advance understanding of sleep in adolescents and if this simple interventions can be&#xD;
        effective in improving their sleep and mental health.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study is a prospective cohort-study implementing a brief behavioral and sleep hygiene&#xD;
        education with mindfulness intervention in adolescents starting a junior collage (16 years of&#xD;
        age). All first year students are invited to participate and those interested, willing to&#xD;
        sign a consent and have a consent from a parent/guardian will be included in the study,&#xD;
        except if diagnosed with chronic atrial fibrillation or ventricular trigemini, severe&#xD;
        uncontrolled asthma, or other pulmonary diseases, or diagnosed with moderate or severe&#xD;
        obstructive sleep apnea (OSA) then will be excluded from participating in the study.&#xD;
  &#xD;
        Sleep duration, sleep timing (sleep onset and conclusion to calculate sleep mid-time and&#xD;
        social jetlag), sleep quality, sleep efficiency and wake after sleep onset will be measured&#xD;
        with objective home sleep test for three (3) week-nights and two (2) weekend-nights.&#xD;
        Sleepiness, insomnia symptoms, anxiety, depression and chronotype will be evaluated with&#xD;
        subjective questionnaires before starting intervention of behavioral and sleep hygiene&#xD;
        education and mindfulness training once weekly. After the 8-week intervention participants&#xD;
        sleep will be measured, sleepiness, insomnia, anxiety, depression symptoms will be&#xD;
        re-evaluated with the same questionnaires and their knowledge of how sleep curtailments may&#xD;
        affect health and quality of life will be tested.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">August 28, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 15, 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>Prospective cohort-study</intervention_model_description>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Chronotype and relationship with sleep duration, anxiety- and depression symptoms</measure>
      <time_frame>Baseline and week 9</time_frame>
      <description>Chronotype evaluated with validated sleep questionnaire the Morningness-Eveningness Questionnaire (MEQ), a nineteen-item questionnaire to assess the preferred timing of sleep and activity (outcome presented on scale of 31-86 points) to identify early-, intermediate- and evening chronotypes and evaluate if the different chronotype-groups differ in sleep duration (evaluated in hours and minutes)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Chronotype and relationship with anxiety symptoms</measure>
      <time_frame>Baseline and week 9</time_frame>
      <description>Chronotype evaluated with validated sleep questionnaire the Morningness-Eveningness Questionnaire (MEQ), a nineteen-item questionnaire to assess the preferred timing of sleep and activity (outcome presented on scale of 31-86 points) to identify early-, intermediate- and evening chronotypes and evaluate if they differ in anxiety symptoms when evaluated with the general anxiety disorder scale-7 (GAD-7), a seven item validated questionnaire designed to screen for and access severity of anxiety (based on scores from 0-21)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Chronotype and relationship with depression symptoms</measure>
      <time_frame>Baseline and week 9</time_frame>
      <description>Chronotype evaluated with validated sleep questionnaire the Morningness-Eveningness Questionnaire (MEQ), a nineteen-item questionnaire to assess the preferred timing of sleep and activity (outcome presented on scale of 31-86 points) to identify early-, intermediate- and evening chronotypes and evaluate if they differ in depression symptoms when evaluated with the patient health questionnaire (PHQ-9), a nine-item validated questionnaire (scores from 0-27), with higher scores indicating more symptoms</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Chronotype and relationship with depression symptoms</measure>
      <time_frame>Baseline and week 9</time_frame>
      <description>Chronotype evaluated with validated sleep questionnaire the Morningness-Eveningness Questionnaire (MEQ), a nineteen-item questionnaire to assess the preferred timing of sleep and activity (outcome presented on scale of 31-86 points) to identify early-, intermediate- and evening chronotypes and evaluate if they differ in depression symptoms when evaluated with the Becks depression inventory (BDI-II) a ten-item questionnaires to screen for and access severity of depression (scores from 0-63) symptoms, with higher scores indicating more symptoms</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in sleep regularity and social jetlag from baseline to follow up after 8-weeks of intervention</measure>
      <time_frame>Baseline and week 9</time_frame>
      <description>Sleep duration, sleep onset and sleep conclusions (all measured in hours and minutes) to calculate sleep midpoint on school- and free days, to calculate social jetlag (in hours and minutes)</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Sleep</condition>
    <condition>Depression</condition>
    <condition>Anxiety</condition>
    <condition>Chronotype</condition>
    <arm_group>
      <arm_group_label>Intervention arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Behavioral and Sleep Hygiene Education with Mindfulness Intervention</intervention_name>
      <description>Education about good sleep hygiene practices and behavior advice to improve sleep based on current literature for 10-15 minutes/week followed by 50 minutes of yoga Nidra and breathing excersices</description>
      <arm_group_label>Intervention arm</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          First year student attending a junior collage in Northern Europe (Akureyri Iceland)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. chronic atrial fibrillation or ventricular trigemini,&#xD;
  &#xD;
            2. severe uncontrolled asthma or other pulmonary diseases,&#xD;
  &#xD;
            3. moderate and severe obstructive sleep apnea (OSA)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>15 Years</minimum_age>
      <maximum_age>17 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Solveig Magnusdottir, MD, MSc, MBA</last_name>
      <role>Principal Investigator</role>
      <affiliation>MyCardio SleepImage</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Menntaskolinn a Akureyri</name>
        <address>
          <city>Akureyri</city>
          <zip>600</zip>
          <country>Iceland</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Sjukrahusid a Akureyri</name>
        <address>
          <city>Akureyri</city>
          <zip>600</zip>
          <country>Iceland</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Iceland</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Akureyri Hospital</investigator_affiliation>
      <investigator_full_name>Solveig Magnusdottir</investigator_full_name>
      <investigator_title>Chief Medical Officer</investigator_title>
    </responsible_party>
    <keyword>sleep regularity</keyword>
    <keyword>sleep duration</keyword>
    <keyword>adolescents</keyword>
    <keyword>behavioral therapy</keyword>
    <keyword>sleep hygiene education</keyword>
    <keyword>mindfulness intervention</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Depression</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>IPD will not be shared</ipd_description>
    </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/NCT06028997
  org study id: VSN-23-086
  nct id: NCT06028997
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Sleep plays a fundamental role in both mental- and physical-health, with good sleep health
        including adequate duration and quality, appropriate timing, regularity, and absence of sleep
        disorders. The purpose of this study is to evaluate sleep in adolescent and if brief
        behavioral and sleep hygiene education with mindfulness intervention improves, sleep timing,
        sleep duration, sleep quality, anxiety- and depression symptoms.
  
        During adolescence extensive physiological changes happen that make it easier for adolescents
        to stay up later, that may increase the time it may take them to fall-asleep and developing
        insomnia symptoms. At the same time psychosocial changes happen, the societal changes in the
        last decade may even have further amplified late sleep in adolescents, with increase in
        social media use and evening screen-time. As sleep need is not decreased and with adolescents
        having to wake up at "socially acceptable times" rather than the endogenous sleep offset
        time, sleep duration may be shortened causing chronic sleep loss and daytime sleepiness.
        Insufficient sleep in adolescents may affect their daytime functioning, causing fatigue and
        memory issues, affect school attendance and academic performance, affect mood, mental- and
        physical health, cause behavioral dysfunction and has been associated with worse health
        outcomes, adverse risk behaviors and even increase risk for accidents.This study should
        advance understanding of sleep in adolescents and if this simple interventions can be
        effective in improving their sleep and mental health.
  The study is a prospective cohort-study implementing a brief behavioral and sleep hygiene
        education with mindfulness intervention in adolescents starting a junior collage (16 years of
        age). All first year students are invited to participate and those interested, willing to
        sign a consent and have a consent from a parent/guardian will be included in the study,
        except if diagnosed with chronic atrial fibrillation or ventricular trigemini, severe
        uncontrolled asthma, or other pulmonary diseases, or diagnosed with moderate or severe
        obstructive sleep apnea (OSA) then will be excluded from participating in the study.
  
        Sleep duration, sleep timing (sleep onset and conclusion to calculate sleep mid-time and
        social jetlag), sleep quality, sleep efficiency and wake after sleep onset will be measured
        with objective home sleep test for three (3) week-nights and two (2) weekend-nights.
        Sleepiness, insomnia symptoms, anxiety, depression and chronotype will be evaluated with
        subjective questionnaires before starting intervention of behavioral and sleep hygiene
        education and mindfulness training once weekly. After the 8-week intervention participants
        sleep will be measured, sleepiness, insomnia, anxiety, depression symptoms will be
        re-evaluated with the same questionnaires and their knowledge of how sleep curtailments may
        affect health and quality of life will be tested.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Prospective cohort-study
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Chronotype and relationship with sleep duration, anxiety- and depression symptoms
  time frame: Baseline and week 9
  description: Chronotype evaluated with validated sleep questionnaire the Morningness-Eveningness Questionnaire (MEQ), a nineteen-item questionnaire to assess the preferred timing of sleep and activity (outcome presented on scale of 31-86 points) to identify early-, intermediate- and evening chronotypes and evaluate if the different chronotype-groups differ in sleep duration (evaluated in hours and minutes)
  measure: Chronotype and relationship with anxiety symptoms
  time frame: Baseline and week 9
  description: Chronotype evaluated with validated sleep questionnaire the Morningness-Eveningness Questionnaire (MEQ), a nineteen-item questionnaire to assess the preferred timing of sleep and activity (outcome presented on scale of 31-86 points) to identify early-, intermediate- and evening chronotypes and evaluate if they differ in anxiety symptoms when evaluated with the general anxiety disorder scale-7 (GAD-7), a seven item validated questionnaire designed to screen for and access severity of anxiety (based on scores from 0-21)
  measure: Chronotype and relationship with depression symptoms
  time frame: Baseline and week 9
  description: Chronotype evaluated with validated sleep questionnaire the Morningness-Eveningness Questionnaire (MEQ), a nineteen-item questionnaire to assess the preferred timing of sleep and activity (outcome presented on scale of 31-86 points) to identify early-, intermediate- and evening chronotypes and evaluate if they differ in depression symptoms when evaluated with the patient health questionnaire (PHQ-9), a nine-item validated questionnaire (scores from 0-27), with higher scores indicating more symptoms
  measure: Chronotype and relationship with depression symptoms
  time frame: Baseline and week 9
  description: Chronotype evaluated with validated sleep questionnaire the Morningness-Eveningness Questionnaire (MEQ), a nineteen-item questionnaire to assess the preferred timing of sleep and activity (outcome presented on scale of 31-86 points) to identify early-, intermediate- and evening chronotypes and evaluate if they differ in depression symptoms when evaluated with the Becks depression inventory (BDI-II) a ten-item questionnaires to screen for and access severity of depression (scores from 0-63) symptoms, with higher scores indicating more symptoms
  measure: Change in sleep regularity and social jetlag from baseline to follow up after 8-weeks of intervention
  time frame: Baseline and week 9
  description: Sleep duration, sleep onset and sleep conclusions (all measured in hours and minutes) to calculate sleep midpoint on school- and free days, to calculate social jetlag (in hours and minutes)
  arm group label: Intervention arm
  arm group type: Experimental
  intervention type: Behavioral
  intervention name: Behavioral and Sleep Hygiene Education with Mindfulness Intervention
  description: Education about good sleep hygiene practices and behavior advice to improve sleep based on current literature for 10-15 minutes/week followed by 50 minutes of yoga Nidra and breathing excersices
  arm group label: Intervention arm
  criteria: 
  gender: All
  minimum age: 15 Years
  maximum age: 17 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Solveig Magnusdottir, MD, MSc, MBA
  role: Principal Investigator
  affiliation: MyCardio SleepImage
  facility: 
  facility: 
  country: Iceland
  responsible party type: Sponsor-Investigator
  investigator affiliation: Akureyri Hospital
  investigator full name: Solveig Magnusdottir
  investigator title: Chief Medical Officer
  mesh term: Depression
  sharing ipd: No
  ipd description: IPD will not be shared