<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/NCT01698411</url>
  </required_header>
  <id_info>
    <org_study_id>C11-57</org_study_id>
    <secondary_id>2012-A00825-38</secondary_id>
    <nct_id>NCT01698411</nct_id>
  </id_info>
  <brief_title>Study of the Influence of Sleep on Hemodynamic Parameters in Patients With Sleep Disorders</brief_title>
  <acronym>HATS</acronym>
  <official_title>Study of the Influence of Sleep on Hemodynamic Parameters in Patients With Sleep Disorders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut National de la Santé Et de la Recherche Médicale, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut National de la Santé Et de la Recherche Médicale, France</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Several epidemiological studies in large cohorts suggest a strong association between sleep&#xD;
      duration, complaint of insomnia and risk of hypertension.These findings suggest an important&#xD;
      role of sleep quality in development of hypertension. Principal limitations of these studies&#xD;
      are the cross-sectional study design, self-report sleep duration and poor measurement of&#xD;
      blood pressure. The investigators propose to study an insomniac population with complete&#xD;
      evaluation of quality and quantity of sleep, associated to complete hemodynamic measurement&#xD;
      of hypertension.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hypertension and sleep disorders is a cross sectional study realised in an adult cohort with&#xD;
      chronic complain of insomnia. In our study, sleep duration is evaluated by complete&#xD;
      evaluation of quality and quantity of sleep: one night PSG, associated with sleep agenda&#xD;
      during 3 weeks, actigraphy, and several sleep questionnaires. We join to this sleep&#xD;
      evaluation, a complete hemodynamic evaluation with: path way velocity and central BP obtained&#xD;
      by tonometry, ambulatory BP measurement (ABBM), and self- BP measurement.&#xD;
&#xD;
      The primary objective of this epidemiological study is to show an increase risk of&#xD;
      hypertension when sleep duration is less than 7 hours, with objective measurement of sleep&#xD;
      duration and hypertension.&#xD;
&#xD;
      Secondary objectives are to evaluate role of complain of insomnia in the risk of&#xD;
      hypertension, and to determine cardiovascular risk in insomnia with hemodynamic explorations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>hypertension</measure>
    <time_frame>one year</time_frame>
    <description>hypertension is defined by blood pressure obtained with 24 hours ambulatory blood pressure measurement when mean blood pressure is over 135/80 in the day, and 125/70 in the night, or when patient take antihypertensive drugs</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>hemodynamic measures</measure>
    <time_frame>one year</time_frame>
    <description>central blood pressure, pathway velocity, blood pressure amplification, visit-to-visit variability of blood pressure, cardiac rhythm variability.</description>
  </secondary_outcome>
  <enrollment type="Actual">90</enrollment>
  <condition>Hypertension</condition>
  <condition>Sleep</condition>
  <condition>Insomnia</condition>
  <eligibility>
    <study_pop>
      <textblock>
        adult with chronic complain of insomnia&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult with insomnia (6 months or more)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  sleep disorders with obstructive apnea&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>jacques blacher, professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institut National de la Santé Et de la Recherche Médicale, France</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>centre du sommeil et de la vigilance, Hotel Dieu</name>
      <address>
        <city>Paris</city>
        <zip>75004</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>July 12, 2012</study_first_submitted>
  <study_first_submitted_qc>September 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <last_update_submitted>August 25, 2021</last_update_submitted>
  <last_update_submitted_qc>August 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>hypertension</keyword>
  <keyword>sleep</keyword>
  <keyword>insomnia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Initiation and Maintenance Disorders</mesh_term>
    <mesh_term>Sleep Wake Disorders</mesh_term>
    <mesh_term>Parasomnias</mesh_term>
    <mesh_term>Hypertension</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/NCT01698411
org study id: C11-57
secondary id: 2012-A00825-38
nct id: NCT01698411
lead sponsor: 
has dmc: No
Several epidemiological studies in large cohorts suggest a strong association between sleep
      duration, complaint of insomnia and risk of hypertension.These findings suggest an important
      role of sleep quality in development of hypertension. Principal limitations of these studies
      are the cross-sectional study design, self-report sleep duration and poor measurement of
      blood pressure. The investigators propose to study an insomniac population with complete
      evaluation of quality and quantity of sleep, associated to complete hemodynamic measurement
      of hypertension.
Hypertension and sleep disorders is a cross sectional study realised in an adult cohort with
      chronic complain of insomnia. In our study, sleep duration is evaluated by complete
      evaluation of quality and quantity of sleep: one night PSG, associated with sleep agenda
      during 3 weeks, actigraphy, and several sleep questionnaires. We join to this sleep
      evaluation, a complete hemodynamic evaluation with: path way velocity and central BP obtained
      by tonometry, ambulatory BP measurement (ABBM), and self- BP measurement.

      The primary objective of this epidemiological study is to show an increase risk of
      hypertension when sleep duration is less than 7 hours, with objective measurement of sleep
      duration and hypertension.

      Secondary objectives are to evaluate role of complain of insomnia in the risk of
      hypertension, and to determine cardiovascular risk in insomnia with hemodynamic explorations.
observational model: Cohort
time perspective: Other
measure: hypertension
time frame: one year
description: hypertension is defined by blood pressure obtained with 24 hours ambulatory blood pressure measurement when mean blood pressure is over 135/80 in the day, and 125/70 in the night, or when patient take antihypertensive drugs
measure: hemodynamic measures
time frame: one year
description: central blood pressure, pathway velocity, blood pressure amplification, visit-to-visit variability of blood pressure, cardiac rhythm variability.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
last name: jacques blacher, professor
role: Principal Investigator
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
facility: 
country: France
responsible party type: Sponsor
mesh term: Sleep Initiation and Maintenance Disorders
mesh term: Sleep Wake Disorders
mesh term: Parasomnias
mesh term: Hypertension