<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/NCT03823105</url>
  </required_header>
  <id_info>
    <org_study_id>2018-00917</org_study_id>
    <nct_id>NCT03823105</nct_id>
  </id_info>
  <brief_title>Validation of Non-invasive Miniature Optical Sensors for Scoring Sleep Stages</brief_title>
  <official_title>Validation of Non-invasive Miniature Optical Sensors for Scoring Sleep Stages: a Prospective, Method-comparison, Proof of Concept, Single-centre Phase IV Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Insel Gruppe AG, University Hospital Bern</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Bern</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Insel Gruppe AG, University Hospital Bern</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>
      Validation of two devices with optical sensor in healthy participants and patients with sleep&#xD;
      wake disorders.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this study is to evaluate and optimize a method of detecting sleep and sleep&#xD;
      stages based on a new algorithm combining actigraphy and heart rate variability (measured by&#xD;
      optical analysis of the pulse wave) to determine sleep architecture (segmented into three&#xD;
      phases: WAKE, REM and NREM) with high accuracy compared to the gold standard polysomnography.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 6, 2018</start_date>
  <completion_date type="Actual">June 10, 2020</completion_date>
  <primary_completion_date type="Actual">April 1, 2020</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total Sleep Time (TST) and sleep architecture (distribution of sleep stages)</measure>
    <time_frame>1 night</time_frame>
    <description>Diagnostic accuracy of the new algorithm compared to the Gold Standard full polysomnography</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The total time in non-REM sleep (stages 1-3), REM sleep, and awake after sleep onset</measure>
    <time_frame>1 night</time_frame>
    <description>Diagnostic accuracy of the new algorithm compared to the Gold Standard full polysomnography</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">69</enrollment>
  <condition>Sleep-Wake Disorders</condition>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Nocturnal Recording</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Recording of photoplethysmographic pulse wave and accelerometry with two devices (OHR Tracker, PulseWatch) in parallel to the standard polysomnography</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>OHR Tracker and PulseWatch</intervention_name>
    <description>Category A (ClinO). Medical study with CE-marked medical devices to photoplethysmographic measure heart rate, heart rate variability, and pulse wave and accelerometric data</description>
    <arm_group_label>Nocturnal Recording</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Patients with sleep wake disorders&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  18 ≤ Age ≤ 80 years&#xD;
&#xD;
          -  Suspected sleep wake disorder (sleep apnea, sleep movement disorders, hypersomnia,&#xD;
             parasomnia)&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Skin condition with eczema or damaged skin&#xD;
&#xD;
          -  Ischemia (cutaneous)&#xD;
&#xD;
          -  Allergy against nickel&#xD;
&#xD;
          -  Allergy against silicone&#xD;
&#xD;
          -  Current treatment with vasoactive drugs (e.g. beta-blockers, calcium channel&#xD;
             antagonists, nitroglycerin, etc.) and/or antidepressive drugs (e.g. serotonin reuptake&#xD;
             inhibitors, etc.).&#xD;
&#xD;
          -  Known infection with multiresistant bacteria&#xD;
&#xD;
          -  Implanted devices (e.g. pacemaker, pumps)&#xD;
&#xD;
          -  Rhythmogenic heart disease (e.g. resting heart rate &gt; 120/min)&#xD;
&#xD;
          -  Severe or untreated arterial hypertension (blood pressure &gt; 140mmHg systolic, &gt;90mmHg&#xD;
             diastolic)&#xD;
&#xD;
          -  Hypotension (blood pressure &lt; 90mmHg systolic, &lt; 60 mmHg diastolic)&#xD;
&#xD;
          -  Current alcohol or drug abuse, alcohol consumption the same day as the study&#xD;
&#xD;
          -  Consumption of coffee 7h before&#xD;
&#xD;
          -  Dark skin pigmentation&#xD;
&#xD;
          -  Severe metabolic disease (e.g. diabetes)&#xD;
&#xD;
          -  Pregnancy or lactation&#xD;
&#xD;
          -  Physical handicap effecting the two arms&#xD;
&#xD;
          -  Wound in the wrist region&#xD;
&#xD;
          -  Too large or too small wrist&#xD;
&#xD;
        Healthy subjects&#xD;
&#xD;
        Inclusion criteria:&#xD;
&#xD;
          -  18 ≤ Age ≤ 80 years&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Skin condition with eczema or damaged skin&#xD;
&#xD;
          -  Ischemia (cutaneous)&#xD;
&#xD;
          -  Allergy against nickel&#xD;
&#xD;
          -  Allergy against silicone&#xD;
&#xD;
          -  Any Medication (except birth control pill)&#xD;
&#xD;
          -  Known infection with multiresistant bacteria&#xD;
&#xD;
          -  Implanted devices (e.g. pacemaker, pumps)&#xD;
&#xD;
          -  Rhythmogenic heart disease (e.g. resting heart rate &gt; 120/min)&#xD;
&#xD;
          -  Severe or untreated arterial hypertension (blood pressure &gt; 140mmHg systolic, &gt;90mmHg&#xD;
             diastolic)&#xD;
&#xD;
          -  Hypotension (blood pressure &lt; 90mmHg systolic, &lt; 60 mmHg diastolic)&#xD;
&#xD;
          -  Current alcohol or drug abuse, alcohol consumption the same day as the study&#xD;
&#xD;
          -  Consumption of coffee 7h before&#xD;
&#xD;
          -  Implanted devices (e.g. pacemaker, pumps)&#xD;
&#xD;
          -  Known sleep-wake disorders&#xD;
&#xD;
          -  Dark skin pigmentation&#xD;
&#xD;
          -  Severe metabolic disease (e.g. diabetes)&#xD;
&#xD;
          -  Pregnancy or lactation&#xD;
&#xD;
          -  Physical handicap effecting the two arms&#xD;
&#xD;
          -  Wound in the wrist region&#xD;
&#xD;
          -  Too large or too small wrist&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sebastian R. Ott, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Berne, Department of Pulmonary Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Bern (Inselspital), Department of Pulmonary Medicine</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>January 29, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>June 11, 2020</last_update_submitted>
  <last_update_submitted_qc>June 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Sleep apnea</keyword>
  <keyword>Hypersomnia</keyword>
  <keyword>Parasomnia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Wake Disorders</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/NCT03823105
org study id: 2018-00917
nct id: NCT03823105
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Validation of two devices with optical sensor in healthy participants and patients with sleep
      wake disorders.
The objective of this study is to evaluate and optimize a method of detecting sleep and sleep
      stages based on a new algorithm combining actigraphy and heart rate variability (measured by
      optical analysis of the pulse wave) to determine sleep architecture (segmented into three
      phases: WAKE, REM and NREM) with high accuracy compared to the gold standard polysomnography.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Total Sleep Time (TST) and sleep architecture (distribution of sleep stages)
time frame: 1 night
description: Diagnostic accuracy of the new algorithm compared to the Gold Standard full polysomnography
measure: The total time in non-REM sleep (stages 1-3), REM sleep, and awake after sleep onset
time frame: 1 night
description: Diagnostic accuracy of the new algorithm compared to the Gold Standard full polysomnography
arm group label: Nocturnal Recording
arm group type: Experimental
description: Recording of photoplethysmographic pulse wave and accelerometry with two devices (OHR Tracker, PulseWatch) in parallel to the standard polysomnography
intervention type: Device
intervention name: OHR Tracker and PulseWatch
description: Category A (ClinO). Medical study with CE-marked medical devices to photoplethysmographic measure heart rate, heart rate variability, and pulse wave and accelerometric data
arm group label: Nocturnal Recording
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sebastian R. Ott, MD
role: Principal Investigator
affiliation: University Hospital Berne, Department of Pulmonary Medicine
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Sleep Wake Disorders
sharing ipd: Undecided