Nasal Airway ObstructionNCT03233373
Thermal Imaging as a Potential Diagnostic Tool of Nasal Airflow
An observational study of Nasal Airway Obstruction, run by New York City Health and Hospitals Corporation at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nasal Airway Obstruction
- What is being tested?
- Seek CompactPro thermal imager
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2017to Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy patients with no present congestion or complaints of nasal obstruction.
Who may be able to join
- All adult patients presenting to the Jacobi Medical Center otolaryngology clinic
Who cannot join
- Patients under the age of 18
- Patients who recently used any nasal decongestants the day of measurement
- Patients with an active infection such as sinusitis
- Patients with anatomical abnormalities such a severe septal deviation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Thermal Imaging as a Potential Diagnostic Tool of Nasal Airflow. A Pilot Study.
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.
Read the detailed description
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.
- Conditions
- Nasal Airway Obstruction
- Being tested
- Seek CompactPro thermal imager
- Keywords
- Nasal Airway Obstruction, Devices, Imaging, Diagnostic, Computer-Assisted Image Processing, Thermal Analysis, Differential
- Medical subject headings
- Nasal Obstruction, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seek CompactPro thermal imagerDevice
A device with image/video recording capability, it is non-invasive and only relies on infrared emissions from heat sources (the patient).
| Study group | Role | What they receive |
|---|---|---|
| Otolaryngology Clinic Patients | 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 Receives: Device: Seek CompactPro thermal imager |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimum temperature in centigrade of patient's reported better (more patent) and worse (less patent) nasal airway
From recorded thermal imaging of nasal respiration cycles of both nostrils (nasal airways)
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Area of cooling of patient's reported better (more patent) and worse (less patent) nasal airway
From recorded thermal imaging of nasal respiration cycles of both nostrils (nasal airways)
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2017
- Study start1 Sep 2017
- Primary completionAug 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Nasal Airway ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York City Health and Hospitals Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Howard Stupak, New York City Health and Hospitals Corporation
- Investigators
- Howard Stupak, MD, Principal investigator, NYCHHC, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03233373
- Sponsor's protocol ID
- 2017-8248
- Status last verified
- Sep 2018
- First submitted
- 17 Jul 2017
- Last updated
- 18 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27918749Roblin 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.
PubMed 12962185Tsounis 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.
PubMed 25073629Willatt DJ. Continuous infrared thermometry of the nasal mucosa. Rhinology. 1993 Jun;31(2):63-7.
PubMed 8362171Willatt 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.
PubMed 9118573Zhao 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.
PubMed 22022361Chaaban 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.
PubMed 21364224
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thermal Imaging as a Potential Diagnostic Tool of Nasal Airflow. A Pilot Study.
- ClinicalTrials.gov ID
- NCT03233373
- Acronym / sponsor ID
- 2017-8248
- Conditions
- Nasal Airway Obstruction
- Keywords
- Nasal Airway Obstruction, Devices, Imaging, Diagnostic, Computer-Assisted Image Processing, Thermal Analysis, Differential
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- New York City Health and Hospitals CorporationUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 28 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Otolaryngology Clinic Patients | – | Device: Seek CompactPro thermal imagerHealthy 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy patients with no present congestion or complaints of nasal obstruction.
Key inclusion criteria (1 listed)
- All adult patients presenting to the Jacobi Medical Center otolaryngology clinic
Key exclusion criteria (4 listed)
- Patients under the age of 18
- Patients who recently used any nasal decongestants the day of measurement
- Patients with an active infection such as sinusitis
- Patients with anatomical abnormalities such a severe septal deviation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Seek CompactPro thermal imagerA device with image/video recording capability, it is non-invasive and only relies on infrared emissions from heat sources (the patient). | Device | Otolaryngology Clinic Patients |
Primary outcome
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
From recorded thermal imaging of nasal respiration cycles of both nostrils (nasal airways)
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2018.
- Background: PubMed 27918749Bailey 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.
- Background: PubMed 12962185Roblin 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.
- Background: PubMed 25073629Tsounis 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.
- Background: PubMed 8362171Willatt DJ. Continuous infrared thermometry of the nasal mucosa. Rhinology. 1993 Jun;31(2):63-7.
- Background: PubMed 9118573Willatt 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.
- Background: PubMed 22022361Zhao 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.
- Background: PubMed 21364224Chaaban 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Howard Stupak, MD principal investigator
NYCHHC, Albert Einstein College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nasal Airway Obstruction, run by New York City Health and Hospitals Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03233373, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2018.