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Effects of Continuous Airway Pressure on the Ability to Heat and Humidify Air
This study has been completed.
Study NCT00338403   Information provided by University of Chicago
First Received: June 15, 2006   Last Updated: May 27, 2008   History of Changes

June 15, 2006
May 27, 2008
June 2006
September 2006   (final data collection date for primary outcome measure)
The amount of water evaporated during the last 5 minutes of exposure to cold, dry air
Same as current
Complete list of historical versions of study NCT00338403 on ClinicalTrials.gov Archive Site
 
 
 
Effects of Continuous Airway Pressure on the Ability to Heat and Humidify Air
Effects of Continuous Airway Pressure on the Ability to Heat and Humidify Air

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.

 
 
Interventional
Other, Randomized, Open Label, Dose Comparison, Crossover Assignment
Healthy
Procedure: Continuous positive airway pressure (CPAP) at -5, 0, 5 and 10 cm of water
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
10
September 2006
September 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Males and females between 18 and 55 years of age.
  2. A clinical history suggestive of normal nose and upper airway, other than during a cold.
  3. Willingness of the subject to participate in and complete the study, and the ability to understand the purpose of the trial.

Exclusion Criteria:

  1. Physical sign or symptoms suggestive of renal, hepatic or cardiovascular disease.
  2. Women of childbearing potential who are pregnant, trying to become pregnant or nursing a child.
  3. Subjects treated with systemic steroids during the previous 30 days.
  4. Subjects treated with topical (inhaled, intranasal or intraocular) steroids, Nasalcrom or Opticrom during the previous 15 days.
  5. Subjects treated with oral antihistamine/decongestants during the previous seven days.
  6. Subjects treated with topical (intranasal or intraocular) antihistamine/decongestants during the previous 3 days.
  7. Subjects treated with immunotherapy.
  8. Subjects on chronic anti-asthma medications.
  9. Subjects with polyps in the nose or a significantly displaced septum.
  10. Subjects who have incurred an upper respiratory tract infection within 14 days of the start of the study.
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00338403
 
14357A
University of Chicago
Fisher and Paykel Healthcare
Principal Investigator: Robert M Naclerio, MD University of Chicago
University of Chicago
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP