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Effects of Humidity (During CPAP Treatment) on Mucociliary Clearance in Patients With Obstructive Sleep Apnea (CIA-6)

Primary Purpose

Obstructive Sleep Apnea

Status
Terminated
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
CPAP + ThermoSmart™ humidity
CPAP + Conventional humidity
CPAP + No added humidity
Sponsored by
Fisher and Paykel Healthcare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Moderate to severe obstructive sleep apnea - Apnea Hypopnea Index (AHI) > 15
  • 75% of events during the diagnostic study must be obstructive

Exclusion Criteria:

  • Currently using CPAP treatment OR have used it in the past 4 weeks
  • Intolerance of CPAP and/or CPAP mask in the past or during the titration night
  • Mouth breather (unable to breath through mouth for the study period)
  • < 18years old
  • Nasal CPAP intolerance determined in the PSG-CPAP titration study
  • Serious nasal issues
  • Acute upper airway disease
  • Smoker
  • COPD
  • Congestive heart failure
  • Neuromuscular disease
  • Stroke

Sites / Locations

  • Faculty of Medicine: Pulmonology: University of Sao Paulo Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

CPAP + ThermoSmart™ humidity

CPAP + Conventional humidity

CPAP + No added humidity

Arm Description

Outcomes

Primary Outcome Measures

mucociliary clearance.

Secondary Outcome Measures

Full Information

First Posted
November 11, 2008
Last Updated
April 25, 2018
Sponsor
Fisher and Paykel Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT00790166
Brief Title
Effects of Humidity (During CPAP Treatment) on Mucociliary Clearance in Patients With Obstructive Sleep Apnea
Acronym
CIA-6
Official Title
Effects of nCPAP With and Without Humidification on: Inspiratory Temperature, Humidity, Saccharine Transit Time, Nasal Lavage and in Vitro Mucus Properties in Patients With Obstructive Sleep Apnea
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Terminated
Study Start Date
October 2008 (undefined)
Primary Completion Date
June 24, 2009 (Actual)
Study Completion Date
June 24, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fisher and Paykel Healthcare

4. Oversight

5. Study Description

Brief Summary
That the level of humidification delivered to patients during CPAP treatment will alter the subjects mucociliary clearance rate and related mucus properties.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CPAP + ThermoSmart™ humidity
Arm Type
Active Comparator
Arm Title
CPAP + Conventional humidity
Arm Type
Active Comparator
Arm Title
CPAP + No added humidity
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
CPAP + ThermoSmart™ humidity
Intervention Description
an absolute humidity (AH) of 28 mg/l +/- 2mg/l
Intervention Type
Device
Intervention Name(s)
CPAP + Conventional humidity
Intervention Description
an absolute humidity (AH) of 18 mg/l +/- 2 mg/l
Intervention Type
Device
Intervention Name(s)
CPAP + No added humidity
Intervention Description
ambient humidity
Primary Outcome Measure Information:
Title
mucociliary clearance.
Time Frame
pre and post cpap treatment with varying levels of humidity

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Moderate to severe obstructive sleep apnea - Apnea Hypopnea Index (AHI) > 15 75% of events during the diagnostic study must be obstructive Exclusion Criteria: Currently using CPAP treatment OR have used it in the past 4 weeks Intolerance of CPAP and/or CPAP mask in the past or during the titration night Mouth breather (unable to breath through mouth for the study period) < 18years old Nasal CPAP intolerance determined in the PSG-CPAP titration study Serious nasal issues Acute upper airway disease Smoker COPD Congestive heart failure Neuromuscular disease Stroke
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geraldo Lorenzi, MD
Organizational Affiliation
Faculty of Medicine: Pulmonology: University of Sao Paulo Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine: Pulmonology: University of Sao Paulo Hospital
City
Sao Paulo
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

Effects of Humidity (During CPAP Treatment) on Mucociliary Clearance in Patients With Obstructive Sleep Apnea

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