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

April 25, 2018 updated by: Fisher and Paykel Healthcare

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CPAP + ThermoSmart™ humidity
Device: CPAP + ThermoSmart™ humidity
an absolute humidity (AH) of 28 mg/l +/- 2mg/l
Active Comparator: CPAP + Conventional humidity
Device: CPAP + Conventional humidity
an absolute humidity (AH) of 18 mg/l +/- 2 mg/l
Active Comparator: CPAP + No added humidity
Device: CPAP + No added humidity
ambient humidity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
mucociliary clearance.
Time Frame: pre and post cpap treatment with varying levels of humidity
pre and post cpap treatment with varying levels of humidity

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fisher and Paykel Healthcare

Investigators

  • Principal Investigator: Geraldo Lorenzi, MD, Faculty of Medicine: Pulmonology: University of Sao Paulo Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

June 24, 2009

Study Completion (Actual)

June 24, 2009

Study Registration Dates

First Submitted

November 11, 2008

First Submitted That Met QC Criteria

November 11, 2008

First Posted (Estimate)

November 13, 2008

Study Record Updates

Last Update Posted (Actual)

April 27, 2018

Last Update Submitted That Met QC Criteria

April 25, 2018

Last Verified

June 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSA CPAP,ThemoSmartMCC, Brasil

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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