Effects of Continuous Airway Pressure on the Ability to Heat and Humidify Air - Full Text View

Sponsors and Collaborators:	University of Chicago Fisher and Paykel Healthcare
Information provided by:	University of Chicago
ClinicalTrials.gov Identifier:	NCT00338403

Purpose

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.

Condition	Intervention
Healthy	Procedure: Continuous positive airway pressure (CPAP) at -5, 0, 5 and 10 cm of water

MedlinePlus related topics: Drinking Water

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Dose Comparison, Crossover Assignment
Official Title:	Effects of Continuous Airway Pressure on the Ability to Heat and Humidify Air

Further study details as provided by University of Chicago:

Primary Outcome Measures:

The amount of water evaporated during the last 5 minutes of exposure to cold, dry air

Estimated Enrollment:	10
Study Start Date:	June 2006
Study Completion Date:	September 2006
Primary Completion Date:	September 2006 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00338403

Locations

United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637

Sponsors and Collaborators

University of Chicago

Fisher and Paykel Healthcare

Investigators

Principal Investigator:

Robert M Naclerio, MD

University of Chicago

More Information

Publications of Results:

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. 1999 Jul;87(1):400-6.

Assanasen 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.

Assanasen 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.

Assanasen 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.

Assanasen 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. 2001 Dec;91(6):2459-65.

Pinto 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. Epub 2004 Jun 1.

Study ID Numbers:	14357A
Study First Received:	June 15, 2006
Last Updated:	May 27, 2008
ClinicalTrials.gov Identifier:	NCT00338403
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Chicago:

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 placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on January 14, 2009