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

This study has been terminated.
Sponsor:
Information provided by:
Fisher and Paykel Healthcare
ClinicalTrials.gov Identifier:
NCT00790166
First received: November 11, 2008
Last updated: June 23, 2009
Last verified: June 2009
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by Fisher and Paykel Healthcare:

Primary Outcome Measures:
  • mucociliary clearance. [ Time Frame: pre and post cpap treatment with varying levels of humidity ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: October 2008
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Georgina Cuttance, Fisher and Paykel Healthcare
ClinicalTrials.gov Identifier: NCT00790166     History of Changes
Other Study ID Numbers: OSA CPAP,ThemoSmartMCC, Brasil
Study First Received: November 11, 2008
Last Updated: June 23, 2009
Health Authority: Brazil: Ministry of Health

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 Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on October 16, 2014