Clinical trial NCT00147888: Changes in Nasal Patency With Changes in Posture, Temperature, Humidity and Nasal Patency Seen by Acoustic Rhinometry
Official title: Physiological Changes in Nasal Patency in Response to Changes in Posture, Temperature, Humidity and Nasal Patency Measured by Acoustic Rhinometry
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Mucosal Congestion
Keywords: Mucosal congestion
Acoustic rhinometry
Physiology
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2005-09-07
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 58
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

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 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

Primary outcomes:
measure: Changes in nasal patency
timeFrame: 5-10 minutes
Secondary outcomes:
measure: Nasal volume
timeFrame: 5-10 minutes
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Jacquelynne P. Corey, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lundqvist GR, Pedersen OF, Hilberg O, Nielsen B. Nasal reaction to changes in whole body temperature. Acta Otolaryngol. 1993 Nov;113(6):783-8. doi: 10.3109/00016489309135901.
citation: Yamagiwa M, Hilberg O, Pedersen OF, Lundqvist GR. Evaluation of the effect of localized skin cooling on nasal airway volume by acoustic rhinometry. Am Rev Respir Dis. 1990 Apr;141(4 Pt 1):1050-4. doi: 10.1164/ajrccm/141.4_Pt_1.1050.
citation: DRETTNER B. VASCULAR REACTIONS ON THE INTAKE OF FOOD AND DRINK OF VARIOUS TEMPERATURES. Acta Otolaryngol Suppl. 1964;188:SUPPL 188:249+. doi: 10.3109/00016486409134570. No abstract available.
citation: Kase Y, Hilberg O, Pedersen OF. Posture and nasal patency: evaluation by acoustic rhinometry. Acta Otolaryngol. 1994 Jan;114(1):70-4. doi: 10.3109/00016489409126019.
citation: Fouke JM, Jackson AC. Acoustic rhinometry: effects of decongestants and posture on nasal patency. J Lab Clin Med. 1992 Apr;119(4):371-6.
citation: Moinuddin R, Mamikoglu B, Barkatullah S, Corey JP. Detection of the nasal cycle. Am J Rhinol. 2001 Jan-Feb;15(1):35-9. doi: 10.2500/105065801781329473.
citation: Haight JJ, Cole P. Reciprocating nasal airflow resistances. Acta Otolaryngol. 1984 Jan-Feb;97(1-2):93-8. doi: 10.3109/00016488409130968.
citation: Hasegawa M. Nasal cycle and postural variations in nasal resistance. Ann Otol Rhinol Laryngol. 1982 Jan-Feb;91(1 Pt 1):112-4. doi: 10.1177/000348948209100125. No abstract available.
citation: Rundcrantz H. Postural variations of nasal patency. Acta Otolaryngol. 1969 Nov;68(5):435-43. doi: 10.3109/00016486909121582. No abstract available.
citation: Bickford L, Shakib S, Taverner D. The nasal airways response in normal subjects to oxymetazoline spray: randomized double-blind placebo-controlled trial. Br J Clin Pharmacol. 1999 Jul;48(1):53-6. doi: 10.1046/j.1365-2125.1999.00972.x.
citation: Mamikoglu B, Houser S, Akbar I, Ng B, Corey JP. Acoustic rhinometry and computed tomography scans for the diagnosis of nasal septal deviation, with clinical correlation. Otolaryngol Head Neck Surg. 2000 Jul;123(1 Pt 1):61-8. doi: 10.1067/mhn.2000.105255.
citation: Corey JP, Gungor A, Nelson R, Fredberg J, Lai V. A comparison of the nasal cross-sectional areas and volumes obtained with acoustic rhinometry and magnetic resonance imaging. Otolaryngol Head Neck Surg. 1997 Oct;117(4):349-54. doi: 10.1016/S0194-5998(97)70125-6.
citation: Corey JP, Nalbone VP, Ng BA. Anatomic correlates of acoustic rhinometry as measured by rigid nasal endoscopy. Otolaryngol Head Neck Surg. 1999 Nov;121(5):572-6. doi: 10.1016/S0194-5998(99)70058-6.
citation: Hendley JO, Abbott RD, Beasley PP, Gwaltney JM Jr. Effect of inhalation of hot humidified air on experimental rhinovirus infection. JAMA. 1994 Apr 13;271(14):1112-3.
citation: Forstall GJ, Macknin ML, Yen-Lieberman BR, Medendrop SV. Effect of inhaling heated vapor on symptoms of the common cold. JAMA. 1994 Apr 13;271(14):1109-11.
citation: Witek TJ Jr, Canestrari DA, Hernandez JR, Miller RD, Yang JY, Riker DK. Superficial nasal mucosal blood flow and nasal patency following topical oxymetazoline hydrochloride. Ann Allergy. 1992 Feb;68(2):165-8.
citation: Corey JP, Kemker BJ, Nelson R, Gungor A. Evaluation of the nasal cavity by acoustic rhinometry in normal and allergic subjects. Otolaryngol Head Neck Surg. 1997 Jul;117(1):22-8. doi: 10.1016/S0194-59989770201-8.
citation: Mamikoglu B, Houser SM, Corey JP. An interpretation method for objective assessment of nasal congestion with acoustic rhinometry. Laryngoscope. 2002 May;112(5):926-9. doi: 10.1097/00005537-200205000-00027.
citation: Taverner D, Bickford L, Shakib S, Tonkin A. Evaluation of the dose-response relationship for intra-nasal oxymetazoline hydrochloride in normal adults. Eur J Clin Pharmacol. 1999 Sep;55(7):509-13. doi: 10.1007/s002280050665.