Skip to main content
Clinical Trials/NCT03233373
NCT03233373UnknownNot Applicable

Thermal Imaging as a Potential Diagnostic Tool of Nasal Airflow. A Pilot Study.

New York City Health and Hospitals Corporation1 site in 1 country40 target enrollmentStarted: September 1, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
40
Locations
1
Primary Endpoint
Minimum temperature in centigrade of patient's reported better (more patent) and worse (less patent) nasal airway

Study Overview

Brief 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.

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

Study Type
Observational
Observational Model
Other
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • All adult patients presenting to the Jacobi Medical Center otolaryngology clinic

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

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)

Secondary Outcomes

  • Area of cooling of patient's reported better (more patent) and worse (less patent) nasal airway(through study completion, an average of 1 year)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Howard Stupak

Director, Department of Otolaryngology at Jacobi Medical Center / Associate Professor Department of Otorhinolaryngology - Albert Einstein College of Medicine

New York City Health and Hospitals Corporation

Study Sites (1)

Loading locations...

Similar Trials