HealthyNCT00338403
Effects of Continuous Airway Pressure on the Ability to Heat and Humidify Air
A study testing Continuous positive airway pressure (CPAP) at -5, 0, 5 and 10 cm of water in people with Healthy, run by University of Chicago at 1 site in United States.
Trial summary
We hypothesize that continuous positive pressure applied to the airway will decrease the ability of the nose to warm and humidify inspired air compared to zero or negative pressure. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Continuous positive airway pressure (CPAP) at -5, 0, 5 and 10 cm of water
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Sep 2006
- Phase
- Interventional
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females between 18 and 55 years of age.
- A clinical history suggestive of normal nose and upper airway, other than during a cold.
- Willingness of the subject to participate in and complete the study, and the ability to understand the purpose of the trial.
Who cannot join
- Physical sign or symptoms suggestive of renal, hepatic or cardiovascular disease.
- Women of childbearing potential who are pregnant, trying to become pregnant or nursing a child.
- Subjects treated with systemic steroids during the previous 30 days.
- Subjects treated with topical (inhaled, intranasal or intraocular) steroids, Nasalcrom or Opticrom during the previous 15 days.
- Subjects treated with oral antihistamine/decongestants during the previous seven days.
- Subjects treated with topical (intranasal or intraocular) antihistamine/decongestants during the previous 3 days.
Show all 10Show fewer
- Subjects treated with immunotherapy.
- Subjects on chronic anti-asthma medications.
- Subjects with polyps in the nose or a significantly displaced septum.
- Subjects who have incurred an upper respiratory tract infection within 14 days of the start of the study.
Trial locations and contacts
1 site in 1 country.
About this study
We hypothesize that continuous positive pressure applied to the airway will decrease the ability of the nose to warm and humidify inspired air compared to zero or negative pressure.
We will use continuous positive airway pressure (CPAP), a device commonly used to treat patients with sleep apnea, to vary the pressure in the airway and determine if increased pressure decreases the ability to warm and humidify inspired air. If our hypothesis is correct, it may explain the reason why CPAP is poorly tolerated in patients with sleep apnea; i.e., less ability to warm and humidify air leading to more nasal mucosal irritation.
- Conditions
- Healthy
- Being tested
- Continuous positive airway pressure (CPAP) at -5, 0, 5 and 10 cm of water
- Keywords
- CPAP pressure of -5cm/water during cold, dry air exposure, CPAP pressure of 0cm/water during cold, dry air exposure, CPAP pressure of 5cm/water during cold, dry air exposure, CPAP pressure of 10cm/water during cold, dry air exposure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous positive airway pressure (CPAP) at -5, 0, 5 and 10 cm of waterProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
The amount of water evaporated during the last 5 minutes of exposure to cold, dry air
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2006 (estimated)
- Study startJun 2006
- Primary completionSep 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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 N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Fisher and Paykel Healthcare
- Responsible party
- Sponsor
- Investigators
- Robert M Naclerio, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00338403
- Sponsor's protocol ID
- 14357A
- Status last verified
- Sep 2013
- First submitted
- 15 Jun 2006
- Last updated
- 5 Sep 2013
- Results posted
- No
Publications
Rouadi P, Baroody FM, Abbott D, Naureckas E, Solway J, Naclerio RM. A technique to measure the ability of the human nose to warm and humidify air. J Appl Physiol (1985). 1999 Jul;87(1):400-6. doi: 10.1152/jappl.1999.87.1.400.
PubMed 10409601Assanasen P, Baroody FM, Rouadi P, Naureckas E, Solway J, Naclerio RM. Ipratropium bromide increases the ability of the nose to warm and humidify air. Am J Respir Crit Care Med. 2000 Sep;162(3 Pt 1):1031-7. doi: 10.1164/ajrccm.162.3.9912055.
PubMed 10988126Assanasen P, Baroody FM, Abbott DJ, Naureckas E, Solway J, Naclerio RM. Natural and induced allergic responses increase the ability of the nose to warm and humidify air. J Allergy Clin Immunol. 2000 Dec;106(6):1045-52. doi: 10.1067/mai.2000.110472.
PubMed 11112885Assanasen P, Baroody FM, Naureckas E, Solway J, Naclerio RM. The nasal passage of subjects with asthma has a decreased ability to warm and humidify inspired air. Am J Respir Crit Care Med. 2001 Nov 1;164(9):1640-6. doi: 10.1164/ajrccm.164.9.2103086.
PubMed 11719303Assanasen P, Baroody FM, Naureckas E, Solway J, Naclerio RM. Supine position decreases the ability of the nose to warm and humidify air. J Appl Physiol (1985). 2001 Dec;91(6):2459-65. doi: 10.1152/jappl.2001.91.6.2459.
PubMed 11717205Pinto JM, Assanasen P, Baroody FM, Naureckas E, Solway J, Naclerio RM. Treatment of nasal inflammation decreases the ability of subjects with asthma to condition inspired air. Am J Respir Crit Care Med. 2004 Oct 15;170(8):863-9. doi: 10.1164/rccm.200309-1271OC. Epub 2004 Jun 1.
PubMed 15172894
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
- Effects of Continuous Airway Pressure on the Ability to Heat and Humidify Air
- ClinicalTrials.gov ID
- NCT00338403
- Acronym / sponsor ID
- 14357A
- Conditions
- Healthy
- Keywords
- CPAP pressure of -5cm/water during cold, dry air exposure, CPAP pressure of 0cm/water during cold, dry air exposure, CPAP pressure of 5cm/water during cold, dry air exposure, CPAP pressure of 10cm/water during cold, dry air exposure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Fisher and Paykel Healthcare
- Study start
- Jun 2006
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 20 Jun 2006 (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.
We hypothesize that continuous positive pressure applied to the airway will decrease the ability of the nose to warm and humidify inspired air compared to zero or negative pressure.
We will use continuous positive airway pressure (CPAP), a device commonly used to treat patients with sleep apnea, to vary the pressure in the airway and determine if increased pressure decreases the ability to warm and humidify inspired air. If our hypothesis is correct, it may explain the reason why CPAP is poorly tolerated in patients with sleep apnea; i.e., less ability to warm and humidify air leading to more nasal mucosal irritation.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Males and females between 18 and 55 years of age.
- A clinical history suggestive of normal nose and upper airway, other than during a cold.
- Willingness of the subject to participate in and complete the study, and the ability to understand the purpose of the trial.
Key exclusion criteria (10 listed)
- Physical sign or symptoms suggestive of renal, hepatic or cardiovascular disease.
- Women of childbearing potential who are pregnant, trying to become pregnant or nursing a child.
- Subjects treated with systemic steroids during the previous 30 days.
- Subjects treated with topical (inhaled, intranasal or intraocular) steroids, Nasalcrom or Opticrom during the previous 15 days.
- Subjects treated with oral antihistamine/decongestants during the previous seven days.
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 |
|---|---|---|
| Continuous positive airway pressure (CPAP) at -5, 0, 5 and 10 cm of water | Procedure or surgery | – |
Primary outcome
The amount of water evaporated during the last 5 minutes of exposure to cold, dry air
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.
- Results publication: PubMed 10409601Rouadi P, Baroody FM, Abbott D, Naureckas E, Solway J, Naclerio RM. A technique to measure the ability of the human nose to warm and humidify air. J Appl Physiol (1985). 1999 Jul;87(1):400-6. doi: 10.1152/jappl.1999.87.1.400.
- Results publication: PubMed 10988126Assanasen P, Baroody FM, Rouadi P, Naureckas E, Solway J, Naclerio RM. Ipratropium bromide increases the ability of the nose to warm and humidify air. Am J Respir Crit Care Med. 2000 Sep;162(3 Pt 1):1031-7. doi: 10.1164/ajrccm.162.3.9912055.
- Results publication: PubMed 11112885Assanasen P, Baroody FM, Abbott DJ, Naureckas E, Solway J, Naclerio RM. Natural and induced allergic responses increase the ability of the nose to warm and humidify air. J Allergy Clin Immunol. 2000 Dec;106(6):1045-52. doi: 10.1067/mai.2000.110472.
- Results publication: PubMed 11719303Assanasen P, Baroody FM, Naureckas E, Solway J, Naclerio RM. The nasal passage of subjects with asthma has a decreased ability to warm and humidify inspired air. Am J Respir Crit Care Med. 2001 Nov 1;164(9):1640-6. doi: 10.1164/ajrccm.164.9.2103086.
- Results publication: PubMed 11717205Assanasen P, Baroody FM, Naureckas E, Solway J, Naclerio RM. Supine position decreases the ability of the nose to warm and humidify air. J Appl Physiol (1985). 2001 Dec;91(6):2459-65. doi: 10.1152/jappl.2001.91.6.2459.
- Results publication: PubMed 15172894Pinto JM, Assanasen P, Baroody FM, Naureckas E, Solway J, Naclerio RM. Treatment of nasal inflammation decreases the ability of subjects with asthma to condition inspired air. Am J Respir Crit Care Med. 2004 Oct 15;170(8):863-9. doi: 10.1164/rccm.200309-1271OC. Epub 2004 Jun 1.
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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.
Robert M Naclerio, MD 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 study testing Continuous positive airway pressure (CPAP) at -5, 0, 5 and 10 cm of water in people with Healthy, 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 3 inclusion and 10 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.
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?
The amount of water evaporated during the last 5 minutes of exposure to cold, dry air. 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 NCT00338403, which also lists 6 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.