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/NCT05964972</url>
    </required_header>
    <id_info>
      <org_study_id>19-145</org_study_id>
      <nct_id>NCT05964972</nct_id>
    </id_info>
    <brief_title>Impact of an Automatic Alert Device on the Occurrence of Nocturnal Falls in Nursing Home Residents</brief_title>
    <acronym>NOCTUSAFE</acronym>
    <official_title>Impact of an Automatic Alert Device on the Occurrence of Nocturnal Falls in Nursing Home Residents</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Caen</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospital, Caen</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>
        Impact of an automatic alert device on the occurrence of nocturnal falls in nursing home&#xD;
        residents Measurement of the number of nocturnal falls between 8 p.m. and 8 a.m. per&#xD;
        registered resident in the 6 months preceding use of the device compared with the number of&#xD;
        nocturnal falls in the 6 months after installation of the device.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">May 17, 2022</start_date>
    <completion_date type="Anticipated">September 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">July 30, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Crossover</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>number of falls</measure>
      <time_frame>6 month preceding and 6 month after</time_frame>
      <description>Measurement of the number of nocturnal falls between 8 p.m. and 8 a.m. per registered resident in the 6 months preceding use of the device compared with the number of nocturnal falls in the 6 months after installation of the device.</description>
    </primary_outcome>
    <enrollment type="Anticipated">14</enrollment>
    <condition>Fall Patients</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Fallers&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Resident of the elderly nursing home (EHPAD LES ORCHIDEES).&#xD;
  &#xD;
            -  Repeated nocturnal falls (more than 2 falls at night between 8 p.m. and 8 a.m.) during&#xD;
               the last 12 months.&#xD;
  &#xD;
            -  Consent of the resident or his legal representative.&#xD;
  &#xD;
            -  Signature of informed consent&#xD;
  &#xD;
            -  French-speaking resident.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Refusal to participate in the study.&#xD;
  &#xD;
            -  Resident exclusive day faller.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Ehpad Les Orchidees</name>
        <address>
          <city>Cagny</city>
          <country>France</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>July 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 20, 2023</last_update_submitted>
    <last_update_submitted_qc>July 20, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT05964972
  org study id: 19-145
  nct id: NCT05964972
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Impact of an automatic alert device on the occurrence of nocturnal falls in nursing home
        residents Measurement of the number of nocturnal falls between 8 p.m. and 8 a.m. per
        registered resident in the 6 months preceding use of the device compared with the number of
        nocturnal falls in the 6 months after installation of the device.
  observational model: Case-Crossover
  time perspective: Cross-Sectional
  measure: number of falls
  time frame: 6 month preceding and 6 month after
  description: Measurement of the number of nocturnal falls between 8 p.m. and 8 a.m. per registered resident in the 6 months preceding use of the device compared with the number of nocturnal falls in the 6 months after installation of the device.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: France
  responsible party type: Sponsor
  sharing ipd: No