<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/NCT03043898</url>
  </required_header>
  <id_info>
    <org_study_id>A093684</org_study_id>
    <nct_id>NCT03043898</nct_id>
  </id_info>
  <brief_title>Mapping Sound Propagation Through the Human Lung for Better Diagnosis</brief_title>
  <official_title>Mapping Sound Propagation Through the Human Lung for Better Diagnosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maximilian Nussbaumer</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cambridge University Hospitals NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Cambridge</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>
      This study investigates the propagation of sound from a source in the chest to the chest&#xD;
      wall.&#xD;
&#xD;
      The methodology of the study will be to place a sound source at a known location in the chest&#xD;
      and measure the acoustic response on the posterior chest wall with an acoustic sensor array.&#xD;
&#xD;
      The sound source will be created by playing sound down the working channel of a bronchoscope&#xD;
      and located anatomically using direct imaging.&#xD;
&#xD;
      Subjects will be selected for the study by asking patients undergoing a bronchoscopy&#xD;
      procedure whether they would be willing to take part in the experiment in addition to their&#xD;
      standard procedure.&#xD;
&#xD;
      Procedures will take place in the Bronchoscopy Unit at Addenbrooke's hospital in Cambridge.&#xD;
      The Unit runs regional speciality clinics in severe chronic obstructive pulmonary disease,&#xD;
      asthma, lung cancer, bronchomalacia and interstitial lung disease and has a nationally&#xD;
      significant interventional bronchoscopy service.&#xD;
&#xD;
      A subsidiary part of the study (Part A) will collect sound recordings from healthy volunteers&#xD;
      and patients with common respiratory diseases using the same acoustic sensor array. This is&#xD;
      to create a database of lung sounds and quantify inter-subject variability.&#xD;
&#xD;
      The study will last approximately 30 months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study has two parts, A and B. Both parts are observational studies of the sounds heard at&#xD;
      the chest as recorded by an acoustic array.&#xD;
&#xD;
      In Part A, healthy volunteers and patients at Addenbrooke's hospital will have the chest&#xD;
      sounds at their back recorded using an electronic-stethoscope array. This will be done in a&#xD;
      single session lasting approximately 30 minutes. 50 healthy volunteers and 100 patients will&#xD;
      be included.&#xD;
&#xD;
      In Part B, 50 patients undergoing a bronchoscopy at Addenbrooke's hospital will have their&#xD;
      bronchoscopy extended by 5-10 minutes so that sounds can be played through the working&#xD;
      channel of the bronchoscope and recorded by a microphone array at the posterior chest. Part B&#xD;
      will investigate 25 patients with structurally 'normal' lungs (for example patients with&#xD;
      Chronic Cough) (Part B(i)), and 25 patients with lung disease that has resulted in an&#xD;
      'abnormal' lung structure (Part B(ii)).&#xD;
&#xD;
      The consultant bronchoscopist will assign the patient to the relevant group based on&#xD;
      information from their medical history and their CT scan. For Part B of the study an existing&#xD;
      CT scan is an inclusion criterion. CT scans will not be carried out specifically for this&#xD;
      study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    COVID-19&#xD;
  </why_stopped>
  <start_date type="Actual">February 14, 2018</start_date>
  <completion_date type="Actual">April 23, 2020</completion_date>
  <primary_completion_date type="Actual">April 23, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of sound propagation through the human chest in subjects with 'normal' and 'abnormal' lung structure.</measure>
    <time_frame>Will be assessed when all data for Part B of the study has been collected. Up to 30 months.</time_frame>
    <description>This will use a hypothesis test on features extracted from the time-series array data in Part B of the study.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Database of acoustic response of human chest to a known sound input within the lungs.</measure>
    <time_frame>Will be assessed when all data for Part B of the study has been collected. Up to 30 months.</time_frame>
    <description>This will consist of acoustic data from an array of acoustic sensors on the posterior back, acoustic data from the sound source, photographs of the back with sensor locations and key anatomical features marked and thorax CT scans. This database will be used to investigate propagation mechanisms and localisation techniques.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Database of lung sound recordings from array on posterior chest.</measure>
    <time_frame>Will be assessed when all data for Part A of the study has been collected. Up to 30 months.</time_frame>
    <description>This will consist of acoustic data from an array of acoustic sensors at the posterior chest of supine participants taken while these perform a series of breathing exercises. The database will also include basic biometric data.</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">62</enrollment>
  <condition>Bronchomalacia</condition>
  <condition>Asthma</condition>
  <condition>Lung Neoplasms</condition>
  <condition>Lung Diseases, Interstitial</condition>
  <condition>Pulmonary Disease, Chronic Obstructive</condition>
  <arm_group>
    <arm_group_label>Part A(i) Healthy Volunteers</arm_group_label>
    <description>50 healthy volunteers. Intervention: Lung sound recording for part A(i) of the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part A(ii) Patients</arm_group_label>
    <description>100 patients with wheezing and/or crackles due to respiratory disease. Intervention: Lung sound recording for part A(ii) of the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B(i) 'normal' lung structure</arm_group_label>
    <description>25 patients who are scheduled to have a Bronchoscopy as part of their standard care and are identified by a medical professional as having a 'normal' lung structure.&#xD;
Intervention: Lung sound transmission measurement for part B(i) of the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B(ii) 'abnormal' lung structure</arm_group_label>
    <description>25 patients who are scheduled to have a Bronchoscopy as part of their standard care and are identified by a medical professional as having an 'abnormal' lung structure.&#xD;
Intervention: Lung sound transmission measurement for part B(ii) of the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Lung sound transmission measurement</intervention_name>
    <description>Sound at chest wall is recorded using a sensor array during the bronchoscopy procedure, while a sound is played down the working channel of the bronchoscope.</description>
    <arm_group_label>Part B(i) 'normal' lung structure</arm_group_label>
    <arm_group_label>Part B(ii) 'abnormal' lung structure</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Lung sound recording</intervention_name>
    <description>Lung sounds are recorded using a sensor array.</description>
    <arm_group_label>Part A(i) Healthy Volunteers</arm_group_label>
    <arm_group_label>Part A(ii) Patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Part A(i) 50 healthy volunteers, taken from the general population.&#xD;
&#xD;
        Part A(ii) 100 patients, taken from the population of patients at Addenbrooke's Hospital,&#xD;
        Cambridge, UK with clear evidence of wheezing and/or crackles due to respiratory disease.&#xD;
        We will aim to recruit approximately 50 patients with wheezing and 50 patients with&#xD;
        crackles.&#xD;
&#xD;
        Part B(i) 25 patients, taken from the population of patients on the bronchoscopy list at&#xD;
        Addenbrooke's Hospital, Cambridge, UK.&#xD;
&#xD;
        Part B(ii) 25 patients, taken from the population of patients on the bronchoscopy list at&#xD;
        Addenbrooke's Hospital, Cambridge, UK&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant is willing and able to give informed consent for participation in the&#xD;
             study.&#xD;
&#xD;
          -  Male of Female, aged 18 years or above.&#xD;
&#xD;
          -  Part A(i) Healthy volunteer with no history of smoking, recreational drug use or&#xD;
             respiratory disease.&#xD;
&#xD;
          -  Part A(ii) Patient admitted to Addenbrooke's with a pulmonary disease resulting in&#xD;
             crackles and/or wheezes (as diagnosed by a qualified medical practitioner).&#xD;
&#xD;
          -  Part B Patient admitted to Addenbrooke's hospital for a bronchoscopy procedure.&#xD;
&#xD;
          -  Part B Appropriate recent imaging available: chest CT within 3 months.&#xD;
&#xD;
          -  Part B(i) Lung structure deemed 'normal' by pulmonary physician based on CT scan and&#xD;
             medical history.&#xD;
&#xD;
          -  Part B(i) Lung structure deemed 'abnormal' by pulmonary physician based on CT scan and&#xD;
             medical history.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Informed consent is not given.&#xD;
&#xD;
          -  Subject is under 18 years old.&#xD;
&#xD;
          -  WHO performance status &gt;2.&#xD;
&#xD;
          -  Subject is pregnant.&#xD;
&#xD;
          -  Subject is unable to understand English.&#xD;
&#xD;
          -  Part A(i) History of smoking, recreational drug use or respiratory disease.&#xD;
&#xD;
          -  Part A(ii) Condition judged to have no effect on breathing sounds. Patient with&#xD;
             crackle or wheeze when quota for crackle or wheeze patients respectively is fulfilled.&#xD;
&#xD;
          -  Part B Risk associated with prolonging bronchoscopy procedure judged to be too high by&#xD;
             medical professional.&#xD;
&#xD;
          -  Part B Appropriate recent imaging (chest CT within 3 months) not available.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pasupathy Sivasothy, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cambridge University Hospitals NHS Foundation Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cambridge University Hospitals and the University of Cambridge</name>
      <address>
        <city>Cambridge</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>January 30, 2017</study_first_submitted>
  <study_first_submitted_qc>February 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 6, 2017</study_first_posted>
  <last_update_submitted>November 3, 2020</last_update_submitted>
  <last_update_submitted_qc>November 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Cambridge</investigator_affiliation>
    <investigator_full_name>Maximilian Nussbaumer</investigator_full_name>
    <investigator_title>Principal Researcher</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Bronchomalacia</mesh_term>
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
    <mesh_term>Lung Diseases, Interstitial</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Non-identifiable patient data will be used in publications and made available on the University of Cambridge's data repository DSpace when the results of the study are published.</ipd_description>
  </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/NCT03043898
org study id: A093684
nct id: NCT03043898
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study investigates the propagation of sound from a source in the chest to the chest
      wall.

      The methodology of the study will be to place a sound source at a known location in the chest
      and measure the acoustic response on the posterior chest wall with an acoustic sensor array.

      The sound source will be created by playing sound down the working channel of a bronchoscope
      and located anatomically using direct imaging.

      Subjects will be selected for the study by asking patients undergoing a bronchoscopy
      procedure whether they would be willing to take part in the experiment in addition to their
      standard procedure.

      Procedures will take place in the Bronchoscopy Unit at Addenbrooke's hospital in Cambridge.
      The Unit runs regional speciality clinics in severe chronic obstructive pulmonary disease,
      asthma, lung cancer, bronchomalacia and interstitial lung disease and has a nationally
      significant interventional bronchoscopy service.

      A subsidiary part of the study (Part A) will collect sound recordings from healthy volunteers
      and patients with common respiratory diseases using the same acoustic sensor array. This is
      to create a database of lung sounds and quantify inter-subject variability.

      The study will last approximately 30 months.
The study has two parts, A and B. Both parts are observational studies of the sounds heard at
      the chest as recorded by an acoustic array.

      In Part A, healthy volunteers and patients at Addenbrooke's hospital will have the chest
      sounds at their back recorded using an electronic-stethoscope array. This will be done in a
      single session lasting approximately 30 minutes. 50 healthy volunteers and 100 patients will
      be included.

      In Part B, 50 patients undergoing a bronchoscopy at Addenbrooke's hospital will have their
      bronchoscopy extended by 5-10 minutes so that sounds can be played through the working
      channel of the bronchoscope and recorded by a microphone array at the posterior chest. Part B
      will investigate 25 patients with structurally 'normal' lungs (for example patients with
      Chronic Cough) (Part B(i)), and 25 patients with lung disease that has resulted in an
      'abnormal' lung structure (Part B(ii)).

      The consultant bronchoscopist will assign the patient to the relevant group based on
      information from their medical history and their CT scan. For Part B of the study an existing
      CT scan is an inclusion criterion. CT scans will not be carried out specifically for this
      study.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Comparison of sound propagation through the human chest in subjects with 'normal' and 'abnormal' lung structure.
time frame: Will be assessed when all data for Part B of the study has been collected. Up to 30 months.
description: This will use a hypothesis test on features extracted from the time-series array data in Part B of the study.
measure: Database of acoustic response of human chest to a known sound input within the lungs.
time frame: Will be assessed when all data for Part B of the study has been collected. Up to 30 months.
description: This will consist of acoustic data from an array of acoustic sensors on the posterior back, acoustic data from the sound source, photographs of the back with sensor locations and key anatomical features marked and thorax CT scans. This database will be used to investigate propagation mechanisms and localisation techniques.
measure: Database of lung sound recordings from array on posterior chest.
time frame: Will be assessed when all data for Part A of the study has been collected. Up to 30 months.
description: This will consist of acoustic data from an array of acoustic sensors at the posterior chest of supine participants taken while these perform a series of breathing exercises. The database will also include basic biometric data.
arm group label: Part A(i) Healthy Volunteers
description: 50 healthy volunteers. Intervention: Lung sound recording for part A(i) of the study.
arm group label: Part A(ii) Patients
description: 100 patients with wheezing and/or crackles due to respiratory disease. Intervention: Lung sound recording for part A(ii) of the study.
arm group label: Part B(i) 'normal' lung structure
description: 25 patients who are scheduled to have a Bronchoscopy as part of their standard care and are identified by a medical professional as having a 'normal' lung structure.
Intervention: Lung sound transmission measurement for part B(i) of the study.
arm group label: Part B(ii) 'abnormal' lung structure
description: 25 patients who are scheduled to have a Bronchoscopy as part of their standard care and are identified by a medical professional as having an 'abnormal' lung structure.
Intervention: Lung sound transmission measurement for part B(ii) of the study.
intervention type: Other
intervention name: Lung sound transmission measurement
description: Sound at chest wall is recorded using a sensor array during the bronchoscopy procedure, while a sound is played down the working channel of the bronchoscope.
arm group label: Part B(i) 'normal' lung structure
arm group label: Part B(ii) 'abnormal' lung structure
intervention type: Other
intervention name: Lung sound recording
description: Lung sounds are recorded using a sensor array.
arm group label: Part A(i) Healthy Volunteers
arm group label: Part A(ii) Patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Pasupathy Sivasothy, PhD
role: Principal Investigator
affiliation: Cambridge University Hospitals NHS Foundation Trust
facility: 
country: United Kingdom
responsible party type: Sponsor-Investigator
investigator affiliation: University of Cambridge
investigator full name: Maximilian Nussbaumer
investigator title: Principal Researcher
mesh term: Lung Neoplasms
mesh term: Bronchomalacia
mesh term: Lung Diseases
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Lung Diseases, Interstitial
sharing ipd: Yes
ipd description: Non-identifiable patient data will be used in publications and made available on the University of Cambridge's data repository DSpace when the results of the study are published.