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Clinical Trials/NCT00338403
NCT00338403CompletedNot Applicable

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

University of Chicago1 site in 1 country10 target enrollmentStarted: June 1, 2006Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
10
Locations
1
Primary Endpoint
The amount of water evaporated during the last 5 minutes of exposure to cold, dry air
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Masking
None

Eligibility Criteria

Ages
18 Years to 55 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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