Comparison of Auto-Adjusting Positive Airway Pressure Devices

ResMed

Status: Completed

Conditions: Obstructive Sleep Apnea

Treatments: Device: APAP A (ResMed AirSense AutoSet); Device: APAP B (Apex iCH Auto)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02357706

MA240115

Details and patient eligibility

About

Little is understood about how different auto-adjusting PAP devices operate. The purpose of this evaluation is to compare two devices in a randomised two night PSG trial.

Enrollment: 20 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males aged ≥ 18 years
• Recently diagnosed with OSA (AHI ≥15). Recently defined as less than 3 months before study entry
• Naive to CPAP therapy
• Participants willing and able to give written informed consent

Exclusion criteria

• Participants requiring Bi-level PAP
• Participants requiring supplemental oxygen
• Participants who are pregnant
• Subjects 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: Single Blind

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20 participants in 2 patient groups

Group 1

Active Comparator group

Description:

Patients will be randomised to either Group 1 or Group 2. Patients in this group (group 1) will use APAP A on the first night of the evaluation, and APAP B on the second night.

Treatment:

Device: APAP B (Apex iCH Auto)

Device: APAP A (ResMed AirSense AutoSet)

Group 2

Active Comparator group

Description:

Patients will be randomised to either Group 1 or Group 2. Patients in this group (group 2) will use APAP B on the first night of the evaluation and APAP A on the second night.

Treatment:

Device: APAP B (Apex iCH Auto)

Device: APAP A (ResMed AirSense AutoSet)