Changes in Nasal Patency With Changes in Posture, Temperature, Humidity and Nasal Patency Seen by Acoustic Rhinometry

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00147888
First received: September 2, 2005
Last updated: September 4, 2013
Last verified: September 2013
  Purpose

To study nasal physiologic responses to changes in posture, temperatures, humidity and nasal patency with acoustic rhinometry.


Condition Intervention Phase
Mucosal Congestion
Procedure: Acoustic rhinometry (procedure)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Physiological Changes in Nasal Patency in Response to Changes in Posture, Temperature, Humidity and Nasal Patency Measured by Acoustic Rhinometry

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Changes in nasal patency [ Time Frame: 5-10 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Nasal volume [ Time Frame: 5-10 minutes ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: March 2004
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Acoustic rhinometry (procedure)
    Acoustic rhinometry is a procedure that uses sound waves to measure the cross-sectional area and volume of the nasal cavity.
Detailed Description:

The purpose of this study was to utilize acoustic rhinometry to assess changes in nasal patency after alterations in posture, unilateral mechanical obstruction, temperature, and humidity.

Eight healthy adult volunteer subjects underwent acoustic rhinometry under the following conditions: 1) upright, sitting position (control), 2) supine position, 3) left lateral recumbent position, 4) one nostril mechanically blocked, 5) icepack on neck, 6) drinking cold water, 7) drinking hot water, 8) nasal nebulizer, 9)oxymetazoline decongestant.

Changes in nasal cavity volumes were detected by acoustic rhinometry after alterations in posture, unilateral mechanical obstruction, temperature, and humidity. Nebulizer treatment and hot water ingestion caused a significant decrease in nasal volume. The nose was able to adapt to environmental and physiological changes in order to maintain a consistent total nasal volume.

  Eligibility

Ages Eligible for Study:   18 Years to 58 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers, 18-58 years old

Exclusion Criteria:

  • Any nasal symptoms in the last 3 weeks
  • Marked septal deviation/polyposis/infection
  • Any history of allergy, asthma or immunodeficiency
  • Any systemic condition or infection (e.g., hypertension/diabetes/heart, liver, thyroid or kidney disease
  • Any spine or neck condition that would not allow normal postures
  • Pregnancy
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00147888

Locations
United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Sanofi
Investigators
Principal Investigator: Jacquelynne P. Corey, M.D. University of Chicago
  More Information

Publications:
Moinuddin R, Mamikoglu B, Barkatullah S, Corey JP. Detection of the nasal cylce. Am J Rhinol 2001;15:35-39

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00147888     History of Changes
Other Study ID Numbers: 13028A
Study First Received: September 2, 2005
Last Updated: September 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
Mucosal congestion
Acoustic rhinometry
Physiology

ClinicalTrials.gov processed this record on October 23, 2014