Comparison of Auto-Adjusting Positive Airway Pressure Devices

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: APAP A (ResMed AirSense AutoSet); Device: APAP B (Apex iCH Auto)

• Registration Number: NCT02357706
• Lead Sponsor: ResMed

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-01-27
• Study First Submitted QC: 2015-02-03
• Study First Posted: 2015-02-06
• Primary Completion: 2015-06
• Study Completion: 2015-12
• Results First Submitted: 2017-04-12
• Status Verified: 2020-04
• Results First Submitted QC: 2020-04-08
• Last Update Submitted: 2020-04-08
• Results First Posted: 2020-04-20
• Last Update Posted: 2020-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 1	APAP A (ResMed AirSense AutoSet)	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.
Group 1	APAP B (Apex iCH Auto)	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.
Group 2	APAP A (ResMed AirSense AutoSet)	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.
Group 2	APAP B (Apex iCH Auto)	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.

Primary Outcome Measures

Name	Time	Method
Mean Oxygen Desaturation Index (ODI)	1 night (446 minutes) for APAP A, 1 night (436 minutes) for APAP B.	Number of times that Oxygen Level Drops by 3% below baseline value, Events/hour
Mean Apnoea-Hypopnoea-Index (AHI)	1 night (446 minutes) for APAP A (AirSense), 1 night (436 minutes) for APAP B (Apex)	AHI measures the number of apnoeas + hypopnoeas per hours of night (events/hour).

Secondary Outcome Measures

Name	Time	Method
Hypopnoea-Index HI	1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B	Number of Hypopnoeas per hour of nights sleep, Events/hour
Flow Limitation (%)	1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B	Percent of flow-limited breaths in relation to the overall breaths at night.
Obstructive Apnoea Index (OAI)	1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B	Number of obstructive apnoeas per hour of nights sleep, Events/hour
Central Apnoea Index (CAI)	1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B	Number of central apnoeas during hours of sleep, events/hour
Respiratory Effort Related Arousals RERAs	1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B	Number of RERAs per hour of nights sleep, Events/hour
Mixed Apnoea Index (MAI)	1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B	Number of obstructive and central apnoeas per hours of nights sleep, Events/hour
Mean O2 Saturation	1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B	Mean blood oxygen Saturation, %

Trial Locations

Locations (1)

Center of Sleep Medicine, Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany