Effects of Continuous Airway Pressure on the Ability to H... | NCT00338403

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

NCT00338403

Sponsor

University of Chicago

Status

Completed

Last Update Posted

Sep 5, 2013Estimated

Enrollment

Phase

Not Applicable

Conditions

Healthy

Interventions

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

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2006

Primary Completion Date

Sep 2006Actual

Completion Date

Sep 2006Actual

First Submitted Date

Jun 15, 2006

First Submission Date that Met QC Criteria

Jun 16, 2006

First Posted Date

Jun 20, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 4, 2013

Last Update Posted Date

Sep 5, 2013Estimated

Name	Class
Fisher and Paykel Healthcare	INDUSTRY

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Continuous positive airway pressure (CPAP) at -5, 0, 5 and 10 cm of water	Procedure

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

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Robert M Naclerio, MD	University of Chicago	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Chicago		Chicago	Illinois	60637	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
10409601	Result	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.
10988126	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.

ID	Term
D045422	Continuous Positive Airway Pressure
D014867	Water

ID	Term
D011175	Positive-Pressure Respiration
D012121	Respiration, Artificial
D058109	Airway Management
D013812	Therapeutics