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/NCT06029881</url>
    </required_header>
    <id_info>
      <org_study_id>B4062023000020</org_study_id>
      <nct_id>NCT06029881</nct_id>
    </id_info>
    <brief_title>Portable System for Non-intrusive Monitoring of Sleep</brief_title>
    <official_title>Validation of a New Non-intrusive Technology for Detecting Sleep Apnea</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Erasme University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Fonds de la Recherche Scientifique (fnrs)</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Erasme University 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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Obstructive sleep apnea (OSA) is a prevalent kind of sleep-disordered breathing affecting&#xD;
        one-seventh of the world's population. Almost 45 percent of this population suffers from mild&#xD;
        to severe apnea. However, in many cases it remains undiagnosed, leading to increased health&#xD;
        risks. Sleep-disordered breathing, as seen in OSA, can have serious long-term consequences,&#xD;
        including sympathetic nervous system activation, sleep disturbances, heart remodeling, and&#xD;
        cardiovascular disease development.&#xD;
  &#xD;
        Polysomnography is the standard method for assessing sleep-breathing disorders, which&#xD;
        requires the attachment of various sensors by a trained technician or a healthcare&#xD;
        professional. However, if the diagnosis of OSA depends on referral to a sleep laboratory, and&#xD;
        if the referral is reliant on symptoms of an OSA syndrome, then current screening approaches&#xD;
        may exclude a large population of individuals at risk. Besides, the number of sleep centers&#xD;
        and caregivers is limited, and the associated costs are high. Therefore, alternative&#xD;
        techniques allowing home monitoring are necessary.&#xD;
  &#xD;
        The goal of this observational study is to evaluate the accuracy of the Kinocardiography&#xD;
        technique in detecting apneic episodes during sleep and comparing the results with the gold&#xD;
        standard polysomnography in 47 patients suffering from obstructive sleep apnea. We&#xD;
        hypothesize that this device is able to detect sleep-disordered breathing events, and thus to&#xD;
        compute the apnea-hypopnea index, with an accuracy that is close to that of the&#xD;
        polysomnography.&#xD;
  &#xD;
        Participants who meet the criteria will be invited to participate in this protocol and do&#xD;
        both polysomnography and kinocardiography records simultaneously at night during sleep.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        1. Study Glossary&#xD;
  &#xD;
               -  BCG = Ballistocardiography&#xD;
  &#xD;
               -  ECG = Electrocardiography&#xD;
  &#xD;
               -  PSG = Polysomnography&#xD;
  &#xD;
               -  SCG = Seismocardiography&#xD;
  &#xD;
               -  KCG = Kinocardiography&#xD;
  &#xD;
          2. Monitoring Technique&#xD;
  &#xD;
             Ballistocardiography (BCG) and seismocardiography (SCG) are two promising technologies&#xD;
             for monitoring vital signs during sleep. BCG measures body movements caused by blood&#xD;
             flow ejection at each cardiac contraction, while SCG detects micro-vibrations from heart&#xD;
             contractions on the chest surface. These low-cost and unobtrusive technologies have been&#xD;
             used in various sleep studies, showing promise in vital sign recording, detecting&#xD;
             abnormal breathing episodes, and studying the effects of disease and environmental&#xD;
             conditions. However, more research and replication of studies are required for&#xD;
             widespread application.&#xD;
  &#xD;
             Kinocardiography:&#xD;
  &#xD;
             Kinocardiography (KCG) is a technique that combines BCG and SCG with electrocardiography&#xD;
             (ECG). The BCG module is placed close to the subject's center of mass in the lumbar&#xD;
             vertebrae. The SCG module is placed on the sternum beneath the clavicle, close to the&#xD;
             heart and major blood vessels. Each module is a MOVESENSE device that incorporates a&#xD;
             three-axis accelerometer and three-axis gyroscope sensor and is attached to the body&#xD;
             using standard sticky gel electrodes and a belt. The overall system is remotely&#xD;
             controlled via a Bluetooth-connected smartphone or tablet. This device allows the&#xD;
             measurement of the micro-accelerations induced by the cardiac activity at the body's&#xD;
             surface. By computing these accelerations, it is possible to calculate other parameters,&#xD;
             such as the kinetic energies associated with the contraction of the heart.&#xD;
  &#xD;
             Polysomnography:&#xD;
  &#xD;
             Polysomnography (PSG) includes various techniques to monitor neurophysiological,&#xD;
             cardiopulmonary, and other physiologic parameters simultaneously. PSG uses&#xD;
             electroencephalogram, electrooculogram, electromyogram, ECG, pulse oximetry, airflow,&#xD;
             and respiratory effort to identify the underlying causes of sleep disturbances.&#xD;
  &#xD;
          3. Safety Reporting&#xD;
  &#xD;
             The MOVESENSE device will be used in this study to collect ECG and signals from&#xD;
             accelerometers and gyroscopes. Once this data has been collected, then the analysis will&#xD;
             be conducted within the Erasme hospital. This device is a CE-marked medical device&#xD;
             (https://ec.europa.eu/tools/eudamed/#/screen/search-device/8d619c90-794a-4564-9a54-829ae&#xD;
             fa9c707).&#xD;
  &#xD;
             The hazard probability is extremely low, and its severity is minimal (the only&#xD;
             possibility is feeling uncomfortable with the electrodes' gel on the skin).&#xD;
  &#xD;
             If a subject becomes uncomfortable, they can call the nurse/operator throughout the&#xD;
             measurement and will be able to let the operator know right away if they want to stop&#xD;
             the measurement.&#xD;
  &#xD;
          4. Strategies for participant recruitment&#xD;
  &#xD;
        The recruitment will be done among the subjects referred for PSG as required by their medical&#xD;
        condition. This study will not affect in any manner the regular medical care of the patients&#xD;
        admitted to the sleep laboratory. Subjects will be recruited within the routine of the sleep&#xD;
        laboratory in the Erasme hospital. Subjects who meet the criteria will be invited to&#xD;
        participate in this protocol and do both PSG and KCG records simultaneously.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 20, 2023</start_date>
    <completion_date type="Anticipated">February 29, 2024</completion_date>
    <primary_completion_date type="Anticipated">February 29, 2024</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <target_duration>1 Day</target_duration>
    <primary_outcome>
      <measure>Sensitivity and Specificity of MOVESENSE sensor in detecting patients suffering from apnea</measure>
      <time_frame>During 1 night (~8hours)</time_frame>
      <description>Sensitivity and Specificity of MOVESENSE sensor in detecting patients suffering from apnea based on the apnea-hypopnea index (AHI) and different grades of severity: AHI&lt;5; 5&lt;AHI&lt;15; 15&lt;AHI&lt;30; 30&lt;AHI.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Variation of kinetic energy during apneic episodes</measure>
      <time_frame>During 1 night (~8hours)</time_frame>
      <description>Measurement of changes in seismocardiography/ballistocardiography integral of kinetic energy (in mJ.s) during and immediately after an apneic episode.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">47</enrollment>
    <condition>Sleep Apnea</condition>
    <arm_group>
      <arm_group_label>Obstructive sleep apnea patients</arm_group_label>
      <description>Patients admitted for complaints of sleep disturbances with no prior significant cardiovascular disease.&#xD;
  Inclusion criteria:&#xD;
  18 &lt; age &lt;70&#xD;
  BMI &lt; 35 kg/m2&#xD;
  Exclusion criteria:&#xD;
  Being under any kind of OSA treatment (cPAP therapy, etc.)&#xD;
  Having been diagnosed with Atrial fibrillation, significant valvular heart disease, or ventricular dysfunction&#xD;
  Age &lt;18 or age &gt; 70&#xD;
  BMI &gt; 35 kg/m2</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Movesense MD</intervention_name>
      <description>This device can be attached to the skin (on the chest and center of mass) during sleep using a belt and adhesive electrodes.</description>
      <arm_group_label>Obstructive sleep apnea patients</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients admitted for complaints of sleep disturbances with no prior treatment for sleep&#xD;
          apnea and no known cardiovascular pathologies.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  The participants should be adult patients who come to Erasme Hospital's sleep&#xD;
               department with complaints about sleep disturbances.&#xD;
  &#xD;
            -  18 &lt; age &lt;70&#xD;
  &#xD;
            -  BMI &lt; 35 kg/m2&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Being under any kind of obstructive sleep apnea treatment (cPAP therapy, etc.)&#xD;
  &#xD;
            -  Having been diagnosed with Atrial fibrillation, significant valvular heart disease, or&#xD;
               ventricular dysfunction&#xD;
  &#xD;
            -  Age &lt;18 or age &gt; 70&#xD;
  &#xD;
            -  BMI &gt; 35 kg/m2&#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>Philippe van de Borne</last_name>
      <role>Principal Investigator</role>
      <affiliation>Professor</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Paniz Balali</last_name>
      <phone>02 555 32 75 ext +32</phone>
      <email>paniz.balali@ulb.be</email>
    </overall_contact>
    <location>
      <facility>
        <name>Erasme hospital</name>
        <address>
          <city>Bruxelles</city>
          <zip>1070</zip>
          <country>Belgium</country>
        </address>
      </facility>
      <contact>
        <last_name>Philippe van de Borne, PhD. MD.</last_name>
        <phone>02 555 39 60 ext +32</phone>
        <email>philippe.vandeborne@hubruxelles.be</email>
      </contact>
      <investigator>
        <last_name>Paniz Balali, MSc</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Philippe van de Borne, PhD. MD.</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Belgium</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Erasme University Hospital</investigator_affiliation>
      <investigator_full_name>Philippe Van de Borne</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>obstructive sleep apnea</keyword>
    <keyword>Ballistocardiography</keyword>
    <keyword>Seismocardiography</keyword>
    <keyword>Polysomnography</keyword>
    <keyword>sleep assessment</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Apnea</mesh_term>
      <mesh_term>Sleep Apnea Syndromes</mesh_term>
    </condition_browse>
    <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/NCT06029881
  org study id: B4062023000020
  nct id: NCT06029881
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  Obstructive sleep apnea (OSA) is a prevalent kind of sleep-disordered breathing affecting
        one-seventh of the world's population. Almost 45 percent of this population suffers from mild
        to severe apnea. However, in many cases it remains undiagnosed, leading to increased health
        risks. Sleep-disordered breathing, as seen in OSA, can have serious long-term consequences,
        including sympathetic nervous system activation, sleep disturbances, heart remodeling, and
        cardiovascular disease development.
  
        Polysomnography is the standard method for assessing sleep-breathing disorders, which
        requires the attachment of various sensors by a trained technician or a healthcare
        professional. However, if the diagnosis of OSA depends on referral to a sleep laboratory, and
        if the referral is reliant on symptoms of an OSA syndrome, then current screening approaches
        may exclude a large population of individuals at risk. Besides, the number of sleep centers
        and caregivers is limited, and the associated costs are high. Therefore, alternative
        techniques allowing home monitoring are necessary.
  
        The goal of this observational study is to evaluate the accuracy of the Kinocardiography
        technique in detecting apneic episodes during sleep and comparing the results with the gold
        standard polysomnography in 47 patients suffering from obstructive sleep apnea. We
        hypothesize that this device is able to detect sleep-disordered breathing events, and thus to
        compute the apnea-hypopnea index, with an accuracy that is close to that of the
        polysomnography.
  
        Participants who meet the criteria will be invited to participate in this protocol and do
        both polysomnography and kinocardiography records simultaneously at night during sleep.
  1. Study Glossary
  
               -  BCG = Ballistocardiography
  
               -  ECG = Electrocardiography
  
               -  PSG = Polysomnography
  
               -  SCG = Seismocardiography
  
               -  KCG = Kinocardiography
  
          2. Monitoring Technique
  
             Ballistocardiography (BCG) and seismocardiography (SCG) are two promising technologies
             for monitoring vital signs during sleep. BCG measures body movements caused by blood
             flow ejection at each cardiac contraction, while SCG detects micro-vibrations from heart
             contractions on the chest surface. These low-cost and unobtrusive technologies have been
             used in various sleep studies, showing promise in vital sign recording, detecting
             abnormal breathing episodes, and studying the effects of disease and environmental
             conditions. However, more research and replication of studies are required for
             widespread application.
  
             Kinocardiography:
  
             Kinocardiography (KCG) is a technique that combines BCG and SCG with electrocardiography
             (ECG). The BCG module is placed close to the subject's center of mass in the lumbar
             vertebrae. The SCG module is placed on the sternum beneath the clavicle, close to the
             heart and major blood vessels. Each module is a MOVESENSE device that incorporates a
             three-axis accelerometer and three-axis gyroscope sensor and is attached to the body
             using standard sticky gel electrodes and a belt. The overall system is remotely
             controlled via a Bluetooth-connected smartphone or tablet. This device allows the
             measurement of the micro-accelerations induced by the cardiac activity at the body's
             surface. By computing these accelerations, it is possible to calculate other parameters,
             such as the kinetic energies associated with the contraction of the heart.
  
             Polysomnography:
  
             Polysomnography (PSG) includes various techniques to monitor neurophysiological,
             cardiopulmonary, and other physiologic parameters simultaneously. PSG uses
             electroencephalogram, electrooculogram, electromyogram, ECG, pulse oximetry, airflow,
             and respiratory effort to identify the underlying causes of sleep disturbances.
  
          3. Safety Reporting
  
             The MOVESENSE device will be used in this study to collect ECG and signals from
             accelerometers and gyroscopes. Once this data has been collected, then the analysis will
             be conducted within the Erasme hospital. This device is a CE-marked medical device
             (https://ec.europa.eu/tools/eudamed/#/screen/search-device/8d619c90-794a-4564-9a54-829ae
             fa9c707).
  
             The hazard probability is extremely low, and its severity is minimal (the only
             possibility is feeling uncomfortable with the electrodes' gel on the skin).
  
             If a subject becomes uncomfortable, they can call the nurse/operator throughout the
             measurement and will be able to let the operator know right away if they want to stop
             the measurement.
  
          4. Strategies for participant recruitment
  
        The recruitment will be done among the subjects referred for PSG as required by their medical
        condition. This study will not affect in any manner the regular medical care of the patients
        admitted to the sleep laboratory. Subjects will be recruited within the routine of the sleep
        laboratory in the Erasme hospital. Subjects who meet the criteria will be invited to
        participate in this protocol and do both PSG and KCG records simultaneously.
  observational model: Case-Only
  time perspective: Prospective
  measure: Sensitivity and Specificity of MOVESENSE sensor in detecting patients suffering from apnea
  time frame: During 1 night (~8hours)
  description: Sensitivity and Specificity of MOVESENSE sensor in detecting patients suffering from apnea based on the apnea-hypopnea index (AHI) and different grades of severity: AHI<5; 5<AHI<15; 15<AHI<30; 30<AHI.
  measure: Variation of kinetic energy during apneic episodes
  time frame: During 1 night (~8hours)
  description: Measurement of changes in seismocardiography/ballistocardiography integral of kinetic energy (in mJ.s) during and immediately after an apneic episode.
  arm group label: Obstructive sleep apnea patients
  description: Patients admitted for complaints of sleep disturbances with no prior significant cardiovascular disease.
  Inclusion criteria:
  18 < age <70
  BMI < 35 kg/m2
  Exclusion criteria:
  Being under any kind of OSA treatment (cPAP therapy, etc.)
  Having been diagnosed with Atrial fibrillation, significant valvular heart disease, or ventricular dysfunction
  Age <18 or age > 70
  BMI > 35 kg/m2
  intervention type: Device
  intervention name: Movesense MD
  description: This device can be attached to the skin (on the chest and center of mass) during sleep using a belt and adhesive electrodes.
  arm group label: Obstructive sleep apnea patients
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Philippe van de Borne
  role: Principal Investigator
  affiliation: Professor
  last name: Paniz Balali
  phone: 02 555 32 75 ext +32
  email: paniz.balali@ulb.be
  facility: 
  contact: 
  investigator: 
  investigator: 
  country: Belgium
  responsible party type: Principal Investigator
  investigator affiliation: Erasme University Hospital
  investigator full name: Philippe Van de Borne
  investigator title: Professor
  mesh term: Apnea
  mesh term: Sleep Apnea Syndromes
  sharing ipd: No