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

This study has been completed.
Sponsor:
Collaborator:
Fisher and Paykel Healthcare
Information provided by:
University of Chicago
ClinicalTrials.gov Identifier:
NCT00338403
First received: June 15, 2006
Last updated: May 27, 2008
Last verified: May 2008
History of Changes
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Effects of Continuous Airway Pressure on the Ability to Heat and Humidify Air

Resource links provided by NLM:

MedlinePlus related topics: Drinking Water
U.S. FDA Resources

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:

  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.
  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:

ClinicalTrials.gov Identifier: NCT00338403     History of Changes
Other Study ID Numbers: 14357A
Study First Received: June 15, 2006
Last Updated: May 27, 2008
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

ClinicalTrials.gov processed this record on May 16, 2013