Effects of Continuous Airway Pressure on the Ability to Heat and Humidify Air

NCT00338403 | Completed

• 1 other identifier: 14357A
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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. 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

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

Outcome Measures

Primary Outcomes (1)

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

Interventions

Continuous positive airway pressure (CPAP) at -5, 0, 5 and 10 cm of water PROCEDURE

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Chicago: lead
• Fisher and Paykel Healthcare: collaborator

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Related Publications (6)

• 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.

  PMID: 10409601 RESULT

• 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. doi: 10.1164/ajrccm.162.3.9912055.

  PMID: 10988126 RESULT

• 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. doi: 10.1067/mai.2000.110472.

  PMID: 11112885 RESULT

• 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. doi: 10.1164/ajrccm.164.9.2103086.

  PMID: 11719303 RESULT

• 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 (1985). 2001 Dec;91(6):2459-65. doi: 10.1152/jappl.2001.91.6.2459.

  PMID: 11717205 RESULT

• 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. doi: 10.1164/rccm.200309-1271OC. Epub 2004 Jun 1.

  PMID: 15172894 RESULT

MeSH Terms

Interventions

Continuous Positive Airway Pressure; Water

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Robert M Naclerio, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2006
• First Posted: June 20, 2006
• Study Start: June 1, 2006
• Primary Completion: September 1, 2006
• Study Completion: September 1, 2006
• Last Updated: September 5, 2013

Record last verified: 2013-09

Locations

US (1)