<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/NCT03022058</url>
  </required_header>
  <id_info>
    <org_study_id>56205</org_study_id>
    <nct_id>NCT03022058</nct_id>
  </id_info>
  <brief_title>Evaluation of the EarEEG System for Detection of Hypoglycaemia-induced Changes in the EEG in Subjects With Type 1 Diabetes</brief_title>
  <official_title>Evaluation of the EarEEG System for Detection of Hypoglycaemia-induced Changes in the EEG in Subjects With Type 1 Diabetes: A Non-controlled, Exploratory Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Odense University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Aarhus</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>T&amp;W Engineering A/S</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>UNEEG Medical A/S</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Odense University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The EarEEG system is a novel non-invasive, unobstructed and discrete method for recording EEG&#xD;
      in which the signal is recorded using dry-contact electrodes embedded on a customised ear&#xD;
      piece. One intended medical indication of the EarEEG system is the detection of&#xD;
      hypoglycaemia-induced changes in the EEG in patients with type 1 diabetes. Currently, no&#xD;
      studies exist investigating the detection of hypoglycaemic episodes by use of ear electrodes.&#xD;
      While a finger prick test accurately measures the blood glucose level, it does not provide&#xD;
      continuous measurements, and hence it is unreliable as a hypoglycaemia alarm. Recent studies&#xD;
      have indicated that the use of continuous glucose monitoring (CGM) reduces the risk of severe&#xD;
      hypoglycaemia. However, some find these devices troublesome to use and utilisation of CGM has&#xD;
      remained limited to date. Observational data show that only a small percentage of patients&#xD;
      with type 1 diabetes are using CGM on an ongoing basis. Thus, there is a medical need for a&#xD;
      reliable hypoglycaemia detection device which is easy and convenient to use.&#xD;
&#xD;
      This clinical study aims at investigating the feasibility of measuring hypoglycaemia induced&#xD;
      changes in the EEG by use of the EarEEG system.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 22, 2017</start_date>
  <completion_date type="Actual">November 16, 2017</completion_date>
  <primary_completion_date type="Actual">November 16, 2017</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>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Presence of significant qEEG hypoglycaemia indicators when comparing normo- and hypoglycaemic EEG as measured by the EarEEG systems for subjects where hypoglycaemia-induced changes have been observed in the scalp EEG (visit 4)</measure>
    <time_frame>Up to 8 hours</time_frame>
    <description>During insulin-induced hypoglycaemia</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Diabetes Mellitus, Type 1</condition>
  <arm_group>
    <arm_group_label>Patients with type 1 diabetes mellitus</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ear-EEG system</intervention_name>
    <description>Measurement of the neural activity in the brain by use of the Ear-EEG device, which is a customized earplug containing 6 embedded dry electrodes placed inside the ear canal and in the concha of the ear.</description>
    <arm_group_label>Patients with type 1 diabetes mellitus</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        For a subject to be eligible, all inclusion criteria must be answered &quot;yes&quot;:&#xD;
&#xD;
          1. Informed consent obtained before any study related activities1&#xD;
&#xD;
          2. Age 18-70 years&#xD;
&#xD;
          3. Patients with type 1 diabetes (duration ≥ 5 years)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        For a subject to be eligible, all exclusion criteria must be answered &quot;no&quot;:&#xD;
&#xD;
          1. Severe cardiac disease&#xD;
&#xD;
               1. History of myocardial infarction&#xD;
&#xD;
               2. Cardiac arrhythmia&#xD;
&#xD;
          2. Previous stroke or cerebral haemorrhage and any other structural cerebral disease&#xD;
&#xD;
          3. Uraemia defined as s-creatinine ≥ 3 times upper reference value,&#xD;
&#xD;
          4. Liver disease defined as s-ALAT ≥ 3 times upper reference interval&#xD;
&#xD;
          5. Epilepsy&#xD;
&#xD;
          6. Use of antiepileptic drugs for any purposes&#xD;
&#xD;
          7. Use of the following drugs: Chemotherapeutic drugs of any kind, methotrexate, third&#xD;
             generation antipsychotic drugs (aripiprazole, quetiapine, clozapine, ziprasidone,&#xD;
             paliperidone, risperidone, sertindole, amisulpride, olanzapine)&#xD;
&#xD;
          8. Known or suspected abuse of alcohol defined as estimated consumption beyond that,&#xD;
             which is recommended by the DHA1 or any other neuro-active substances&#xD;
&#xD;
          9. Use of hearing aid or cochlear implants2&#xD;
&#xD;
         10. Allergic contact dermatitis caused by metals or generally prone to skin irritation&#xD;
&#xD;
         11. Narrow or malformed ear canals&#xD;
&#xD;
         12. Patients that are judged incapable of understanding the patient information or who are&#xD;
             not capable of carrying through the investigation&#xD;
&#xD;
         13. Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Henning Beck-Nielsen, DMSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Odense University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Diabetes Research Center</name>
      <address>
        <city>Odense</city>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>December 13, 2016</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 16, 2017</study_first_posted>
  <last_update_submitted>April 9, 2018</last_update_submitted>
  <last_update_submitted_qc>April 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Odense University Hospital</investigator_affiliation>
    <investigator_full_name>Henning Beck-Nielsen</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
    <mesh_term>Hypoglycemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03022058
org study id: 56205
nct id: NCT03022058
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The EarEEG system is a novel non-invasive, unobstructed and discrete method for recording EEG
      in which the signal is recorded using dry-contact electrodes embedded on a customised ear
      piece. One intended medical indication of the EarEEG system is the detection of
      hypoglycaemia-induced changes in the EEG in patients with type 1 diabetes. Currently, no
      studies exist investigating the detection of hypoglycaemic episodes by use of ear electrodes.
      While a finger prick test accurately measures the blood glucose level, it does not provide
      continuous measurements, and hence it is unreliable as a hypoglycaemia alarm. Recent studies
      have indicated that the use of continuous glucose monitoring (CGM) reduces the risk of severe
      hypoglycaemia. However, some find these devices troublesome to use and utilisation of CGM has
      remained limited to date. Observational data show that only a small percentage of patients
      with type 1 diabetes are using CGM on an ongoing basis. Thus, there is a medical need for a
      reliable hypoglycaemia detection device which is easy and convenient to use.

      This clinical study aims at investigating the feasibility of measuring hypoglycaemia induced
      changes in the EEG by use of the EarEEG system.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Presence of significant qEEG hypoglycaemia indicators when comparing normo- and hypoglycaemic EEG as measured by the EarEEG systems for subjects where hypoglycaemia-induced changes have been observed in the scalp EEG (visit 4)
time frame: Up to 8 hours
description: During insulin-induced hypoglycaemia
arm group label: Patients with type 1 diabetes mellitus
arm group type: Experimental
intervention type: Device
intervention name: Ear-EEG system
description: Measurement of the neural activity in the brain by use of the Ear-EEG device, which is a customized earplug containing 6 embedded dry electrodes placed inside the ear canal and in the concha of the ear.
arm group label: Patients with type 1 diabetes mellitus
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Henning Beck-Nielsen, DMSc
role: Principal Investigator
affiliation: Odense University Hospital
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Odense University Hospital
investigator full name: Henning Beck-Nielsen
investigator title: Professor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
mesh term: Hypoglycemia
sharing ipd: Undecided