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/NCT05972161</url>
    </required_header>
    <id_info>
      <org_study_id>SCH-2173</org_study_id>
      <nct_id>NCT05972161</nct_id>
    </id_info>
    <brief_title>Measuring Breathing Airflow Using a Heat Sensitive Camera (ThermFlow)</brief_title>
    <acronym>ThermFlow</acronym>
    <official_title>High Resolution Thermal Imaging Developments for Non-Contact Airflow Measurement: A Novel Child-friendly Method to Monitor Paediatric Airflow.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sheffield Children's NHS Foundation Trust</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sheffield Children's NHS Foundation Trust</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>
        ThermPaed is a Sheffield Children's Hospital research collaborative which investigated the&#xD;
        clinical diagnostic capabilities of high resolution thermal imaging (HRTI) in paediatrics.&#xD;
        This research utilises thermal imaging techniques to detect fractures, arthritic inflammation&#xD;
        and infection. ThermPaed proved HRTI has potential in paediatrics and resulted in development&#xD;
        of techniques that has led to the current research study. The purpose of this study is to&#xD;
        develop HRTI as a non-contact child-friendly means of measuring and monitoring paediatric&#xD;
        airflow.&#xD;
  &#xD;
        Sheffield Children's Hospital Sleep Unit performs 500 sleep studies a year to investigate&#xD;
        paediatric sleep-related breathing disorders. 1-6% of children have problems with their&#xD;
        breathing during sleep and have breathing pauses called apnoeas. The condition needs accurate&#xD;
        diagnosis and treatment to ensure correct blood oxygen levels. During a sleep study a number&#xD;
        of physiological parameters are measured. These include heart rate, chest movements, airflow,&#xD;
        oxygen levels, body position, snoring, movement and video. A total of 13 sensors are attached&#xD;
        to the child whilst awake, and then the child settles to sleep. Airflow parameters are&#xD;
        measured by two contact sensors; one measures airflow by temperature and the other measures&#xD;
        airflow by pressure. Both sensors are placed in or very close to the nostrils to detect and&#xD;
        classify apnoea. Due to their contact nature, these sensors are poorly tolerated. In a recent&#xD;
        survey of 100 sleep studies on the sleep unit, 50% children did not allow the sensors to be&#xD;
        attached or removed them immediately causing difficulties in interpreting their condition.&#xD;
  &#xD;
        Breathing generates changes in temperature around nose and mouth which can be detected with&#xD;
        HRTI. The investigators will recruit 30 children who are undergoing a sleep study. The&#xD;
        investigators will compare airflow measurements from the existing clinical nasal sensors and&#xD;
        HRTI to evaluate whether this new technique will provide an accurate non-contact alternative&#xD;
        to measure respiration airflow.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study will form part of a wider project currently ongoing which is looking into&#xD;
        development of HRTI for clinical diagnosis and monitoring. It builds on the significant&#xD;
        progress the investigators made through the ThermPaed study. Sheffield Hallam University&#xD;
        supports this study by allocating an MPhil student (UR). The student will be jointly&#xD;
        supervised at the University by Professor Saatchi who is well-established in digital signal&#xD;
        and image processing and Professor Elphick and Dr Kingshott.&#xD;
  &#xD;
        This study design is explained below. Measurement of thermal imaging alongside standard&#xD;
        clinical parameters Following ethics and HRA approval, the investigators will identify 30&#xD;
        suitable children attending Sheffield Children's Hospital Sleep Unit who are undergoing&#xD;
        cardiorespiratory PSG investigation for sleep-related breathing disorders.&#xD;
  &#xD;
        Each patient would undergo the standard diagnostic cardiorespiratory PSG and wear all the&#xD;
        sensors as usual. In addition, following consent, HRTI will be performed in the Sleep Unit&#xD;
        overnight. The HRTI device will be positioned alongside the standard video camera used in&#xD;
        PSG. The standard recording time of a PSG study is between 8-12 hours and is determined by&#xD;
        the child and their age-related sleep and wake times. Even if the child does not tolerate the&#xD;
        nasal sensors, the investigators will record HRTI to identify potentially missed apnoea&#xD;
        events. The study therefore does not interfere in any way with the patient's normal&#xD;
        procedures.&#xD;
  &#xD;
        Patient, carer and staff opinions of the HRTI versus conventional nasal sensors.&#xD;
  &#xD;
        As part of the research, the participating children, their attending carer and overnight&#xD;
        sleep nursing staff will complete an evaluation questionnaire [Appendix 1] in the morning&#xD;
        following the PSG.&#xD;
  &#xD;
        Development of software to integrate the HRTI data with the PSG sleep system&#xD;
  &#xD;
        The HRTI data recording and processing will be carried out by the MPhil student, supervised&#xD;
        by his university tutor. The data will be stored on a password secure laptop during the&#xD;
        recording and then transferred and stored in a safe, secure and password protected drive at&#xD;
        Sheffield Hallam University. Each participating patient will be assigned a unique identifying&#xD;
        number (see sections 5.3 and 6.0). There will not be any identifiable patient information&#xD;
        with these recordings. The PSG data are downloaded onto a sleep software system at the&#xD;
        hospital and then the anonymised version of the airflow signals will be stored at Sheffield&#xD;
        Hallam University research secure drive. This sleep software has the ability to export its&#xD;
        data anonymously and so currently can be integrated alongside the HRTI data. Workflow on&#xD;
        integrating these two sets of data will include:&#xD;
  &#xD;
          -  Discussion with the sleep software company to directly integrate the thermal imaging&#xD;
             data into the sleep software.&#xD;
  &#xD;
          -  Time synchronising the two data sets. Blinded scoring analysis of the signals to compare&#xD;
             apnoea event scoring and classification Once each child's data are collected, Dr&#xD;
             Kingshott will interpret the PSG data to identify apnoea events. Following standard AASM&#xD;
             scoring guidelines apnoeas will be marked using the nasal sensor channels versus the&#xD;
             HRTI channel. In order to minimise scoring bias, the processing order for HRTI versus&#xD;
             the data from the nasal sensors will be randomised.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">October 24, 2017</start_date>
    <completion_date type="Actual">June 26, 2018</completion_date>
    <primary_completion_date type="Actual">June 26, 2018</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>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Comparing accuracy of the nasal sensors vs Thermal Imaging camera. Data downloaded on a software system</measure>
      <time_frame>10 months</time_frame>
      <description>Agreement between the apnoeas measured by HRTI and the apnoeas measured by nasal sensors.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>How successful are nasal sensors in an overnight study. Data downloaded on a software system</measure>
      <time_frame>10 months</time_frame>
      <description>Success rates of nasal sensors in situ overnight</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>How Successful is Thermal Imaging overnight. Data downloaded on a software system</measure>
      <time_frame>10 months</time_frame>
      <description>Success rates of HRTI image in frame overnight</description>
    </secondary_outcome>
    <enrollment type="Actual">30</enrollment>
    <condition>Sleep Apnea</condition>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Thermal Imaging camera</intervention_name>
      <description>Thermal Imaging camera used to measure respiratory flow.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Children age 0-15.9 years Are attending the sleep unit for a cardiorespiratory sleep study&#xD;
          to investigate or monitor sleep-disordered breathing&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Children age 0-15.9 years Are attending the sleep unit for a cardiorespiratory sleep&#xD;
               study to investigate or monitor sleep-disordered breathing&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Families who do not understand written or verbal English where no interpreter is&#xD;
               present&#xD;
  &#xD;
            -  Children who do not attend with their parent / legal guardian and so are therefore&#xD;
               unable to give informed consent&#xD;
  &#xD;
            -  Children who are undergoing tracheostomy or ventilation sleep studies and so will not&#xD;
               be expected to wear nasal airflow sensors during their sleep study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>0 Years</minimum_age>
      <maximum_age>15 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Heather Elphick</last_name>
      <role>Principal Investigator</role>
      <affiliation>Sheffield Childrens NHS Foundation Trust</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>CRF, Sheffield Childrens Hospital</name>
        <address>
          <city>Sheffield</city>
          <zip>S10 2TH</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>December 2019</verification_date>
    <study_first_submitted>June 15, 2018</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 24, 2023</last_update_submitted>
    <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <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/NCT05972161
  org study id: SCH-2173
  nct id: NCT05972161
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  ThermPaed is a Sheffield Children's Hospital research collaborative which investigated the
        clinical diagnostic capabilities of high resolution thermal imaging (HRTI) in paediatrics.
        This research utilises thermal imaging techniques to detect fractures, arthritic inflammation
        and infection. ThermPaed proved HRTI has potential in paediatrics and resulted in development
        of techniques that has led to the current research study. The purpose of this study is to
        develop HRTI as a non-contact child-friendly means of measuring and monitoring paediatric
        airflow.
  
        Sheffield Children's Hospital Sleep Unit performs 500 sleep studies a year to investigate
        paediatric sleep-related breathing disorders. 1-6% of children have problems with their
        breathing during sleep and have breathing pauses called apnoeas. The condition needs accurate
        diagnosis and treatment to ensure correct blood oxygen levels. During a sleep study a number
        of physiological parameters are measured. These include heart rate, chest movements, airflow,
        oxygen levels, body position, snoring, movement and video. A total of 13 sensors are attached
        to the child whilst awake, and then the child settles to sleep. Airflow parameters are
        measured by two contact sensors; one measures airflow by temperature and the other measures
        airflow by pressure. Both sensors are placed in or very close to the nostrils to detect and
        classify apnoea. Due to their contact nature, these sensors are poorly tolerated. In a recent
        survey of 100 sleep studies on the sleep unit, 50% children did not allow the sensors to be
        attached or removed them immediately causing difficulties in interpreting their condition.
  
        Breathing generates changes in temperature around nose and mouth which can be detected with
        HRTI. The investigators will recruit 30 children who are undergoing a sleep study. The
        investigators will compare airflow measurements from the existing clinical nasal sensors and
        HRTI to evaluate whether this new technique will provide an accurate non-contact alternative
        to measure respiration airflow.
  The study will form part of a wider project currently ongoing which is looking into
        development of HRTI for clinical diagnosis and monitoring. It builds on the significant
        progress the investigators made through the ThermPaed study. Sheffield Hallam University
        supports this study by allocating an MPhil student (UR). The student will be jointly
        supervised at the University by Professor Saatchi who is well-established in digital signal
        and image processing and Professor Elphick and Dr Kingshott.
  
        This study design is explained below. Measurement of thermal imaging alongside standard
        clinical parameters Following ethics and HRA approval, the investigators will identify 30
        suitable children attending Sheffield Children's Hospital Sleep Unit who are undergoing
        cardiorespiratory PSG investigation for sleep-related breathing disorders.
  
        Each patient would undergo the standard diagnostic cardiorespiratory PSG and wear all the
        sensors as usual. In addition, following consent, HRTI will be performed in the Sleep Unit
        overnight. The HRTI device will be positioned alongside the standard video camera used in
        PSG. The standard recording time of a PSG study is between 8-12 hours and is determined by
        the child and their age-related sleep and wake times. Even if the child does not tolerate the
        nasal sensors, the investigators will record HRTI to identify potentially missed apnoea
        events. The study therefore does not interfere in any way with the patient's normal
        procedures.
  
        Patient, carer and staff opinions of the HRTI versus conventional nasal sensors.
  
        As part of the research, the participating children, their attending carer and overnight
        sleep nursing staff will complete an evaluation questionnaire [Appendix 1] in the morning
        following the PSG.
  
        Development of software to integrate the HRTI data with the PSG sleep system
  
        The HRTI data recording and processing will be carried out by the MPhil student, supervised
        by his university tutor. The data will be stored on a password secure laptop during the
        recording and then transferred and stored in a safe, secure and password protected drive at
        Sheffield Hallam University. Each participating patient will be assigned a unique identifying
        number (see sections 5.3 and 6.0). There will not be any identifiable patient information
        with these recordings. The PSG data are downloaded onto a sleep software system at the
        hospital and then the anonymised version of the airflow signals will be stored at Sheffield
        Hallam University research secure drive. This sleep software has the ability to export its
        data anonymously and so currently can be integrated alongside the HRTI data. Workflow on
        integrating these two sets of data will include:
  
          -  Discussion with the sleep software company to directly integrate the thermal imaging
             data into the sleep software.
  
          -  Time synchronising the two data sets. Blinded scoring analysis of the signals to compare
             apnoea event scoring and classification Once each child's data are collected, Dr
             Kingshott will interpret the PSG data to identify apnoea events. Following standard AASM
             scoring guidelines apnoeas will be marked using the nasal sensor channels versus the
             HRTI channel. In order to minimise scoring bias, the processing order for HRTI versus
             the data from the nasal sensors will be randomised.
  observational model: Cohort
  time perspective: Prospective
  measure: Comparing accuracy of the nasal sensors vs Thermal Imaging camera. Data downloaded on a software system
  time frame: 10 months
  description: Agreement between the apnoeas measured by HRTI and the apnoeas measured by nasal sensors.
  measure: How successful are nasal sensors in an overnight study. Data downloaded on a software system
  time frame: 10 months
  description: Success rates of nasal sensors in situ overnight
  measure: How Successful is Thermal Imaging overnight. Data downloaded on a software system
  time frame: 10 months
  description: Success rates of HRTI image in frame overnight
  intervention type: Device
  intervention name: Thermal Imaging camera
  description: Thermal Imaging camera used to measure respiratory flow.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 0 Years
  maximum age: 15 Years
  healthy volunteers: No
  last name: Heather Elphick
  role: Principal Investigator
  affiliation: Sheffield Childrens NHS Foundation Trust
  facility: 
  country: United Kingdom
  responsible party type: Sponsor
  mesh term: Sleep Apnea Syndromes
  sharing ipd: No