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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00790166
Recruitment Status : Terminated
First Posted : November 13, 2008
Last Update Posted : June 24, 2009
Sponsor:
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Device: CPAP + ThermoSmart™ humidity Device: CPAP + Conventional humidity Device: CPAP + No added humidity Phase 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 Start Date : October 2008
Estimated Primary Completion Date : October 2009
Estimated Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. mucociliary clearance. [ Time Frame: pre and post cpap treatment with varying levels of humidity ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00790166


Locations
Brazil
Faculty of Medicine: Pulmonology: University of Sao Paulo Hospital
Sao Paulo, Brazil
Sponsors and Collaborators
Fisher and Paykel Healthcare
Investigators
Principal Investigator: Geraldo - Lorenzi, MD Faculty of Medicine: Pulmonology: University of Sao Paulo Hospital
More Information

Responsible Party: Georgina Cuttance, Fisher and Paykel Healthcare
ClinicalTrials.gov Identifier: NCT00790166     History of Changes
Other Study ID Numbers: OSA CPAP,ThemoSmartMCC, Brasil
First Posted: November 13, 2008    Key Record Dates
Last Update Posted: June 24, 2009
Last Verified: June 2009

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases