Thermal Imaging as a Potential Diagnostic Tool of Nasal Airflow

NCT03233373 | Unknown

• 1 other identifier: 2017-8248
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasal Airway Obstruction

Keywords

Nasal Airway Obstruction; Devices; Imaging, Diagnostic; Computer-Assisted Image Processing; Thermal Analysis, Differential

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Area of cooling of patient's reported better (more patent) and worse (less patent) nasal airway

  through study completion, an average of 1 year

Study Arms (1)

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

Device: Seek CompactPro thermal imager

Interventions

Seek CompactPro thermal imager DEVICE

A device with image/video recording capability, it is non-invasive and only relies on infrared emissions from heat sources (the patient).

Otolaryngology Clinic Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy patients with no present congestion or complaints of nasal obstruction.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• New York City Health and Hospitals Corporation: lead

Study Sites (1)

Jacobi Medical Center

The Bronx, New York, 10461, United States

Location

Related Publications (7)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Willatt DJ. Continuous infrared thermometry of the nasal mucosa. Rhinology. 1993 Jun;31(2):63-7.

  PMID: 8362171 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Nasal Obstruction; Disease

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Howard Stupak, MD

  NYCHHC, Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Otolaryngology at Jacobi Medical Center / Associate Professor Department of Otorhinolaryngology - Albert Einstein College of Medicine

Study Record Dates

• First Submitted: July 17, 2017
• First Posted: July 28, 2017
• Study Start: September 1, 2017
• Primary Completion: August 1, 2020
• Study Completion: September 1, 2020
• Last Updated: September 18, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)