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

Fisher & Paykel Healthcare

Status: Terminated

Conditions: Obstructive Sleep Apnea

Treatments: Device: CPAP + Conventional humidity; Device: CPAP + ThermoSmart™ humidity; Device: CPAP + No added humidity

Study type: Interventional

Funder types: Industry

Identifiers

NCT00790166

OSA CPAP,ThemoSmartMCC, Brasil

Details and patient eligibility

About

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

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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4 participants in 3 patient groups

CPAP + ThermoSmart™ humidity

Active Comparator group

Treatment:

Device: CPAP + ThermoSmart™ humidity

CPAP + Conventional humidity

Active Comparator group

Treatment:

Device: CPAP + Conventional humidity

CPAP + No added humidity

Active Comparator group

Treatment:

Device: CPAP + No added humidity