Nasal Pillows vs. Nasal Masks at High CPAP Pressure

ResMed

Status: Completed

Conditions: OSA

Treatments: Device: Pillows mask; Device: Nasal mask

Study type: Interventional

Funder types: Industry

Identifiers

NCT01690923

MA000-1442

Details and patient eligibility

About

The aim of this evaluation is to test:

1. Whether using nasal pillows at high pressures has comparable outcomes to nasal masks
2. Patient mask type preferences at high pressures

Enrollment: 20 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients willing to give written informed consent
• Patients who can read and comprehend English
• Patients being treated for OSA for >6 months
• Patients ≥ 18 years of age
• Patients using nasal mask systems with fixed pressure ≥ 12 cm H2O
• Patients who can trial the trial masks up to 14 nights
• Patients naive to pillows mask systems

Exclusion criteria

• Patients using an inappropriate mask system
• Patients using Bilevel flow generators
• Patients who are pregnant
• Patients who have a pre-existing lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (< 2years) case of pneumonia or lung infection; lung injury)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Nasal Mask First, then Pillows Mask

Experimental group

Description:

Nasal mask is used for 7 nights, then followed by Pillows mask for 7 nights. \[Nasal mask=Mirage Activa, Micro, FX; Pillows mask=Swift FX\]

Treatment:

Device: Pillows mask

Device: Nasal mask

Pillows Mask, then Nasal Mask

Experimental group

Description:

Pillows mask for 7 nights, then followed by Nasal mask is used for 7 nights. \[Nasal mask=MMirage Activa, Micro, FX; Pillows mask=Swift FX\]

Treatment:

Device: Pillows mask

Device: Nasal mask