Mucosal CongestionPhase 4NCT00147888
Changes in Nasal Patency With Changes in Posture, Temperature, Humidity and Nasal Patency Seen by Acoustic Rhinometry
A Phase 4 study testing Acoustic rhinometry (procedure) in people with Mucosal Congestion, run by University of Chicago at 1 site in United States.
Trial summary
To study nasal physiologic responses to changes in posture, temperatures, humidity and nasal patency with acoustic rhinometry. Read more about this study
- Who is it for?
- Ages 18 to 58 yearsHealthy volunteers can take part
- Conditions the study is for
- Mucosal Congestion
- What is being tested?
- Acoustic rhinometry (procedure)
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2004to Dec 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 58 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers, 18-58 years old
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physiological Changes in Nasal Patency in Response to Changes in Posture, Temperature, Humidity and Nasal Patency Measured by Acoustic Rhinometry
To study nasal physiologic responses to changes in posture, temperatures, humidity and nasal patency with acoustic rhinometry.
Read the 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.
- Conditions
- Mucosal Congestion
- Being tested
- Acoustic rhinometry (procedure)
- Keywords
- Mucosal congestion, Acoustic rhinometry, Physiology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acoustic rhinometry (procedure)Procedure or surgery
Acoustic rhinometry is a procedure that uses sound waves to measure the cross-sectional area and volume of the nasal cavity.
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in nasal patency
Measured: 5-10 minutes
Secondary outcomes (1)
Nasal volume
Measured: 5-10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2005 (estimated)
- Study startMar 2004
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Mucosal CongestionStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Jacquelynne P. Corey, M.D., Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00147888
- Sponsor's protocol ID
- 13028A
- Status last verified
- Sep 2013
- First submitted
- 2 Sep 2005
- Last updated
- 5 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 8291439Yamagiwa 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.
PubMed 2327639DRETTNER 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.
PubMed 14147452Kase 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.
PubMed 8128857Fouke JM, Jackson AC. Acoustic rhinometry: effects of decongestants and posture on nasal patency. J Lab Clin Med. 1992 Apr;119(4):371-6.
PubMed 1583387Moinuddin 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.
PubMed 11258653Haight JJ, Cole P. Reciprocating nasal airflow resistances. Acta Otolaryngol. 1984 Jan-Feb;97(1-2):93-8. doi: 10.3109/00016488409130968.
PubMed 6689832Hasegawa 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.
PubMed 7073167Rundcrantz H. Postural variations of nasal patency. Acta Otolaryngol. 1969 Nov;68(5):435-43. doi: 10.3109/00016486909121582. No abstract available.
PubMed 5378632Bickford 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.
PubMed 10383560Mamikoglu 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.
PubMed 10889483Corey 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.
PubMed 9339795Corey 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.
PubMed 10547472Hendley 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.
PubMed 8151855Forstall 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.
PubMed 8151854
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Changes in Nasal Patency in Response to Changes in Posture, Temperature, Humidity and Nasal Patency Measured by Acoustic Rhinometry
- ClinicalTrials.gov ID
- NCT00147888
- Acronym / sponsor ID
- 13028A
- Conditions
- Mucosal Congestion
- Keywords
- Mucosal congestion, Acoustic rhinometry, Physiology
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Mar 2004
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 7 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 58 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy volunteers, 18-58 years old
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acoustic rhinometry (procedure)Acoustic rhinometry is a procedure that uses sound waves to measure the cross-sectional area and volume of the nasal cavity. | Procedure or surgery | – |
Primary outcome
Changes in nasal patency
Time frame: 5-10 minutes
1 secondary outcome
Nasal volume
Time frame: 5-10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2013.
- Background: PubMed 8291439Lundqvist 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.
- Background: PubMed 2327639Yamagiwa 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.
- Background: PubMed 14147452DRETTNER 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.
- Background: PubMed 8128857Kase 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.
- Background: PubMed 1583387Fouke JM, Jackson AC. Acoustic rhinometry: effects of decongestants and posture on nasal patency. J Lab Clin Med. 1992 Apr;119(4):371-6.
- Background: PubMed 11258653Moinuddin 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.
- Background: PubMed 6689832Haight JJ, Cole P. Reciprocating nasal airflow resistances. Acta Otolaryngol. 1984 Jan-Feb;97(1-2):93-8. doi: 10.3109/00016488409130968.
- Background: PubMed 7073167Hasegawa 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.
- Background: PubMed 5378632Rundcrantz H. Postural variations of nasal patency. Acta Otolaryngol. 1969 Nov;68(5):435-43. doi: 10.3109/00016486909121582. No abstract available.
- Background: PubMed 10383560Bickford 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.
- Background: PubMed 10889483Mamikoglu 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.
- Background: PubMed 9339795Corey 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacquelynne P. Corey, M.D. principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acoustic rhinometry (procedure) in people with Mucosal Congestion, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in nasal patency (time frame: 5-10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00147888, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2013; AzTrials last refreshed its copy on 28 Oct 2026.