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

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

This study is currently recruiting participants.

Verified by Fisher and Paykel Healthcare, November 2008

Sponsored by:	Fisher and Paykel Healthcare
Information provided by:	Fisher and Paykel Healthcare
ClinicalTrials.gov Identifier:	NCT00790166

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 I Phase II

MedlinePlus related topics: Sleep Apnea

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Uncontrolled, Crossover Assignment, Efficacy Study
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

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00790166

Contacts

Contact: Geraldo - Lorenzi, MD

55 11 3066 ext 7214

geraldo.lorenzi@incor.usp.br

Locations

Brazil, -
Faculty of Medicine: Pulmonology: University of Sao Paulo Hospital	Recruiting
Sao Paulo, -, Brazil, -
Contact: Geraldo - Lorenzi, MD

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:	Fisher and Paykel Healthcare ( Georgina Cuttance )
Study ID Numbers:	OSA CPAP,ThemoSmartMCC, Brasil
Study First Received:	November 11, 2008
Last Updated:	November 11, 2008
ClinicalTrials.gov Identifier:	NCT00790166
Health Authority:	Brazil: Ministry of Health

Study placed in the following topic categories:

Signs and Symptoms
Sleep Apnea Syndromes
Respiratory Tract Diseases
Apnea
Respiration Disorders

Sleep Apnea, Obstructive
Dyssomnias
Sleep Disorders
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009