Comparison of Auto-Adjusting Positive Airway Pressure Devices

ResMed20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Obstructive Sleep Apnea

Interventions

APAP A (ResMed AirSense AutoSet)DEVICE

Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events

APAP B (Apex iCH Auto)DEVICE

Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Center of Sleep Medicine, Charité - Universitätsmedizin Berlin

Berlin, Germany

Outcomes

Primary Outcomes

Mean Apnoea-Hypopnoea-Index (AHI)

AHI measures the number of apnoeas + hypopnoeas per hours of night (events/hour).

Time frame: 1 night (446 minutes) for APAP A (AirSense), 1 night (436 minutes) for APAP B (Apex)

Mean Oxygen Desaturation Index (ODI)

Number of times that Oxygen Level Drops by 3% below baseline value, Events/hour

Time frame: 1 night (446 minutes) for APAP A, 1 night (436 minutes) for APAP B.