<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/NCT03233373</url>
  </required_header>
  <id_info>
    <org_study_id>2017-8248</org_study_id>
    <nct_id>NCT03233373</nct_id>
  </id_info>
  <brief_title>Thermal Imaging as a Potential Diagnostic Tool of Nasal Airflow</brief_title>
  <official_title>Thermal Imaging as a Potential Diagnostic Tool of Nasal Airflow. A Pilot Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>New York City Health and Hospitals Corporation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>New York City Health and Hospitals Corporation</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Currently, there are no tools that can measure nasal airflow in an objective manner that is&#xD;
      non-invasive to the patient. This clinical study aims to address this by evaluating the use&#xD;
      of thermal imaging as a diagnostic tool for measuring nasal airflow.&#xD;
&#xD;
      Proper airflow cools the nasal airway as it passes--obstructions or narrowed airways hinder&#xD;
      flow and results in elevated temperatures along the airway and nasal tissue. It is this&#xD;
      elevation in temperature, or more specifically, loss of cooling, that we hypothesize to be&#xD;
      measurable with thermal imaging. Participants in this study will be asked to perform 3-4&#xD;
      nasal breathing cycles which will be recorded by the thermal imager.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Currently there's no non-invasive, objective method for measuring nasal airflow. The current&#xD;
      standard, the NOSE score is an inaccurate measure of physiology (it is subjective). There is&#xD;
      a considerable amount of data that demonstrates that the nasopharyngeal airway is the&#xD;
      preferred ventilatory pathway for breathing at rest and during sleep. Finding a reliable&#xD;
      measurement modality is important in light of this. The primary goal of this study is to&#xD;
      evaluate a novel approach to measuring nasal airflow in thermal imaging. Previous studies&#xD;
      show that higher temperatures of the nasal mucosa are related to decreased patency. The&#xD;
      investigators hypothesize that reduced or obstructed airflow leads to the loss of the cooling&#xD;
      oscillatory cycle present in normal nasal respiration. The investigators believe this&#xD;
      diminished or absent cycle may be detectable via thermal imaging due to predicted elevation&#xD;
      of mucosal temperatures (or loss of the cooling gradient). Other methods in the past aimed at&#xD;
      measuring temperature changes introduced error due to their invasiveness (irritation of the&#xD;
      mucosa lead to higher baseline oscillatory cycles). This is no longer an issue as the thermal&#xD;
      imager requires no physical contact with the patient to function.&#xD;
&#xD;
      There are several methods for measuring nasal patency that have been described throughout the&#xD;
      literature. These include objective measurements such as acoustic rhinometry and&#xD;
      rhinomanometry, as well as subjective measurements such as the Sino-Nasal Outcome Test and&#xD;
      Nasal Obstruction Symptom Evaluation (NOSE) questionnaires. More recently, snap-on thermal&#xD;
      imaging devices that take advantage of the processing power and high resolution of modern&#xD;
      phones have surfaced leading to lower costs for highly-sensitive devices that we aim to use&#xD;
      for measuring nasal airflow. The non-invasive nature of using thermal devices may lead to&#xD;
      more accurate, objective measurements of nasal airflow as a previous study demonstrated that&#xD;
      tactile irritation from other devices increase the mucosal temperature impeding measurement.&#xD;
      (Bailey et al.). Other studies documented that improved sensation of nasal airflow is&#xD;
      associated with cooler mucosal temperatures and that increased patency of the nasal passage&#xD;
      is related to lower temperatures as well (and the opposite, decreased patency to increased&#xD;
      temperatures). (Willatt et al.) We hypothesize that nasal airflow obstruction (NAO) leads to&#xD;
      the loss of the cooling oscillatory cycle present in normal nasal respiration which we can&#xD;
      detect via thermal imaging due to predicted elevation of mucosal temperatures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Anticipated">September 2020</completion_date>
  <primary_completion_date type="Anticipated">August 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Minimum temperature in centigrade of patient's reported better (more patent) and worse (less patent) nasal airway</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>From recorded thermal imaging of nasal respiration cycles of both nostrils (nasal airways)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area of cooling of patient's reported better (more patent) and worse (less patent) nasal airway</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>From recorded thermal imaging of nasal respiration cycles of both nostrils (nasal airways)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Nasal Airway Obstruction</condition>
  <arm_group>
    <arm_group_label>Otolaryngology Clinic Patients</arm_group_label>
    <description>Healthy subjects with no present complaints of nasal obstructions. Patients visiting the clinic, once consented, will be asked which nostril they breathe better from. They will then be asked to perform 3-4 normal respiration cycles through their nose which will be recorded using our thermal imaging device, the Seek CompactPro thermal imager</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Seek CompactPro thermal imager</intervention_name>
    <description>A device with image/video recording capability, it is non-invasive and only relies on infrared emissions from heat sources (the patient).</description>
    <arm_group_label>Otolaryngology Clinic Patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy patients with no present congestion or complaints of nasal obstruction.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - All adult patients presenting to the Jacobi Medical Center otolaryngology clinic&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients under the age of 18&#xD;
&#xD;
          -  Patients who recently used any nasal decongestants the day of measurement&#xD;
&#xD;
          -  Patients with an active infection such as sinusitis&#xD;
&#xD;
          -  Patients with anatomical abnormalities such a severe septal deviation&#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>Howard Stupak, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYCHHC, Albert Einstein College of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jacobi Medical Center</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10461</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Bailey RS, Casey KP, Pawar SS, Garcia GJ. Correlation of Nasal Mucosal Temperature With Subjective Nasal Patency in Healthy Individuals. JAMA Facial Plast Surg. 2017 Jan 1;19(1):46-52. doi: 10.1001/jamafacial.2016.1445.</citation>
    <PMID>27918749</PMID>
  </reference>
  <reference>
    <citation>Roblin DG, Eccles R. Normal range for nasal partitioning of airflow determined by nasal spirometry in 100 healthy subjects. Am J Rhinol. 2003 Jul-Aug;17(4):179-83.</citation>
    <PMID>12962185</PMID>
  </reference>
  <reference>
    <citation>Tsounis M, Swart KM, Georgalas C, Markou K, Menger DJ. The clinical value of peak nasal inspiratory flow, peak oral inspiratory flow, and the nasal patency index. Laryngoscope. 2014 Dec;124(12):2665-9. doi: 10.1002/lary.24810. Epub 2014 Jul 30.</citation>
    <PMID>25073629</PMID>
  </reference>
  <reference>
    <citation>Willatt DJ. Continuous infrared thermometry of the nasal mucosa. Rhinology. 1993 Jun;31(2):63-7.</citation>
    <PMID>8362171</PMID>
  </reference>
  <reference>
    <citation>Willatt DJ, Jones AS. The role of the temperature of the nasal lining in the sensation of nasal patency. Clin Otolaryngol Allied Sci. 1996 Dec;21(6):519-23. doi: 10.1111/j.1365-2273.1996.tb01102.x.</citation>
    <PMID>9118573</PMID>
  </reference>
  <reference>
    <citation>Zhao K, Blacker K, Luo Y, Bryant B, Jiang J. Perceiving nasal patency through mucosal cooling rather than air temperature or nasal resistance. PLoS One. 2011;6(10):e24618. doi: 10.1371/journal.pone.0024618. Epub 2011 Oct 13.</citation>
    <PMID>22022361</PMID>
  </reference>
  <reference>
    <citation>Chaaban M, Corey JP. Assessing nasal air flow: options and utility. Proc Am Thorac Soc. 2011 Mar;8(1):70-8. doi: 10.1513/pats.201005-034RN.</citation>
    <PMID>21364224</PMID>
  </reference>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>July 17, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <last_update_submitted>September 15, 2018</last_update_submitted>
  <last_update_submitted_qc>September 15, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>New York City Health and Hospitals Corporation</investigator_affiliation>
    <investigator_full_name>Howard Stupak</investigator_full_name>
    <investigator_title>Director, Department of Otolaryngology at Jacobi Medical Center / Associate Professor Department of Otorhinolaryngology - Albert Einstein College of Medicine</investigator_title>
  </responsible_party>
  <keyword>Nasal Airway Obstruction</keyword>
  <keyword>Devices</keyword>
  <keyword>Imaging, Diagnostic</keyword>
  <keyword>Computer-Assisted Image Processing</keyword>
  <keyword>Thermal Analysis, Differential</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Airway Obstruction</mesh_term>
    <mesh_term>Nasal Obstruction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>March 27, 2021</submitted>
    <returned>April 22, 2021</returned>
  </pending_results>
  <!-- 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/NCT03233373
org study id: 2017-8248
nct id: NCT03233373
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Currently, there are no tools that can measure nasal airflow in an objective manner that is
      non-invasive to the patient. This clinical study aims to address this by evaluating the use
      of thermal imaging as a diagnostic tool for measuring nasal airflow.

      Proper airflow cools the nasal airway as it passes--obstructions or narrowed airways hinder
      flow and results in elevated temperatures along the airway and nasal tissue. It is this
      elevation in temperature, or more specifically, loss of cooling, that we hypothesize to be
      measurable with thermal imaging. Participants in this study will be asked to perform 3-4
      nasal breathing cycles which will be recorded by the thermal imager.
Currently there's no non-invasive, objective method for measuring nasal airflow. The current
      standard, the NOSE score is an inaccurate measure of physiology (it is subjective). There is
      a considerable amount of data that demonstrates that the nasopharyngeal airway is the
      preferred ventilatory pathway for breathing at rest and during sleep. Finding a reliable
      measurement modality is important in light of this. The primary goal of this study is to
      evaluate a novel approach to measuring nasal airflow in thermal imaging. Previous studies
      show that higher temperatures of the nasal mucosa are related to decreased patency. The
      investigators hypothesize that reduced or obstructed airflow leads to the loss of the cooling
      oscillatory cycle present in normal nasal respiration. The investigators believe this
      diminished or absent cycle may be detectable via thermal imaging due to predicted elevation
      of mucosal temperatures (or loss of the cooling gradient). Other methods in the past aimed at
      measuring temperature changes introduced error due to their invasiveness (irritation of the
      mucosa lead to higher baseline oscillatory cycles). This is no longer an issue as the thermal
      imager requires no physical contact with the patient to function.

      There are several methods for measuring nasal patency that have been described throughout the
      literature. These include objective measurements such as acoustic rhinometry and
      rhinomanometry, as well as subjective measurements such as the Sino-Nasal Outcome Test and
      Nasal Obstruction Symptom Evaluation (NOSE) questionnaires. More recently, snap-on thermal
      imaging devices that take advantage of the processing power and high resolution of modern
      phones have surfaced leading to lower costs for highly-sensitive devices that we aim to use
      for measuring nasal airflow. The non-invasive nature of using thermal devices may lead to
      more accurate, objective measurements of nasal airflow as a previous study demonstrated that
      tactile irritation from other devices increase the mucosal temperature impeding measurement.
      (Bailey et al.). Other studies documented that improved sensation of nasal airflow is
      associated with cooler mucosal temperatures and that increased patency of the nasal passage
      is related to lower temperatures as well (and the opposite, decreased patency to increased
      temperatures). (Willatt et al.) We hypothesize that nasal airflow obstruction (NAO) leads to
      the loss of the cooling oscillatory cycle present in normal nasal respiration which we can
      detect via thermal imaging due to predicted elevation of mucosal temperatures.
observational model: Other
time perspective: Cross-Sectional
measure: Minimum temperature in centigrade of patient's reported better (more patent) and worse (less patent) nasal airway
time frame: through study completion, an average of 1 year
description: From recorded thermal imaging of nasal respiration cycles of both nostrils (nasal airways)
measure: Area of cooling of patient's reported better (more patent) and worse (less patent) nasal airway
time frame: through study completion, an average of 1 year
description: From recorded thermal imaging of nasal respiration cycles of both nostrils (nasal airways)
arm group label: Otolaryngology Clinic Patients
description: Healthy subjects with no present complaints of nasal obstructions. Patients visiting the clinic, once consented, will be asked which nostril they breathe better from. They will then be asked to perform 3-4 normal respiration cycles through their nose which will be recorded using our thermal imaging device, the Seek CompactPro thermal imager
intervention type: Device
intervention name: Seek CompactPro thermal imager
description: A device with image/video recording capability, it is non-invasive and only relies on infrared emissions from heat sources (the patient).
arm group label: Otolaryngology Clinic 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: Howard Stupak, MD
role: Principal Investigator
affiliation: NYCHHC, Albert Einstein College of Medicine
facility: 
country: United States
citation: Bailey RS, Casey KP, Pawar SS, Garcia GJ. Correlation of Nasal Mucosal Temperature With Subjective Nasal Patency in Healthy Individuals. JAMA Facial Plast Surg. 2017 Jan 1;19(1):46-52. doi: 10.1001/jamafacial.2016.1445.
PMID: 27918749
citation: Roblin DG, Eccles R. Normal range for nasal partitioning of airflow determined by nasal spirometry in 100 healthy subjects. Am J Rhinol. 2003 Jul-Aug;17(4):179-83.
PMID: 12962185
citation: Tsounis M, Swart KM, Georgalas C, Markou K, Menger DJ. The clinical value of peak nasal inspiratory flow, peak oral inspiratory flow, and the nasal patency index. Laryngoscope. 2014 Dec;124(12):2665-9. doi: 10.1002/lary.24810. Epub 2014 Jul 30.
PMID: 25073629
citation: Willatt DJ. Continuous infrared thermometry of the nasal mucosa. Rhinology. 1993 Jun;31(2):63-7.
PMID: 8362171
citation: Willatt DJ, Jones AS. The role of the temperature of the nasal lining in the sensation of nasal patency. Clin Otolaryngol Allied Sci. 1996 Dec;21(6):519-23. doi: 10.1111/j.1365-2273.1996.tb01102.x.
PMID: 9118573
citation: Zhao K, Blacker K, Luo Y, Bryant B, Jiang J. Perceiving nasal patency through mucosal cooling rather than air temperature or nasal resistance. PLoS One. 2011;6(10):e24618. doi: 10.1371/journal.pone.0024618. Epub 2011 Oct 13.
PMID: 22022361
citation: Chaaban M, Corey JP. Assessing nasal air flow: options and utility. Proc Am Thorac Soc. 2011 Mar;8(1):70-8. doi: 10.1513/pats.201005-034RN.
PMID: 21364224
responsible party type: Principal Investigator
investigator affiliation: New York City Health and Hospitals Corporation
investigator full name: Howard Stupak
investigator title: Director, Department of Otolaryngology at Jacobi Medical Center / Associate Professor Department of Otorhinolaryngology - Albert Einstein College of Medicine
mesh term: Airway Obstruction
mesh term: Nasal Obstruction
sharing ipd: No
submitted: March 27, 2021
returned: April 22, 2021