Nasal Airway Obstruction Clinical Trial
Official title:
Thermal Imaging as a Potential Diagnostic Tool of Nasal Airflow. A Pilot Study.
Verified date | September 2018 |
Source | New York City Health and Hospitals Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Enrolling by invitation |
Enrollment | 40 |
Est. completion date | September 2020 |
Est. primary completion date | August 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Jacobi Medical Center | Bronx | New York |
Lead Sponsor | Collaborator |
---|---|
New York City Health and Hospitals Corporation |
United States,
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. — View 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. — View 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. — View 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. — View 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. — View Citation
Willatt DJ. Continuous infrared thermometry of the nasal mucosa. Rhinology. 1993 Jun;31(2):63-7. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | through study completion, an average of 1 year | |
Secondary | 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) | through study completion, an average of 1 year |
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