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

Obstructive Sleep Apnea Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00790166
• Other study ID #: OSA CPAP,ThemoSmartMCC, Brasil
• Status: Terminated
• Phase: N/A
• First received: November 11, 2008
• Last updated: April 25, 2018
• Start date: October 2008
• Est. completion date: June 24, 2009

Study information

• Verified date: June 2009
• Source: Fisher and Paykel Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: June 24, 2009
• Est. primary completion date: June 24, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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

Locations

Country	Name	City	State
Brazil	Faculty of Medicine: Pulmonology: University of Sao Paulo Hospital	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Fisher and Paykel Healthcare

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mucociliary clearance.		pre and post cpap treatment with varying levels of humidity