Comparison of Auto-Adjusting Positive Airway Pressure Devices

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 Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Device: APAP A (ResMed AirSense AutoSet); Device: APAP B (Apex iCH Auto)

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Center of Sleep Medicine, Charité - Universitätsmedizin Berlin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1; 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.	Device: APAP A (ResMed AirSense AutoSet); Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events; Other Names: Auto-Adjusting Positive Airway Pressure Device A; Device: APAP B (Apex iCH Auto); Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events; Other Names: Auto-Adjusting Positive Airway Pressure Device B
Active Comparator: Group 2; 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.	Device: APAP A (ResMed AirSense AutoSet); Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events; Other Names: Auto-Adjusting Positive Airway Pressure Device A; Device: APAP B (Apex iCH Auto); Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events; Other Names: Auto-Adjusting Positive Airway Pressure Device B

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Apnoea-Hypopnoea-Index (AHI)	AHI measures the number of apnoeas + hypopnoeas per hours of night (events/hour).	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	1 night (446 minutes) for APAP A, 1 night (436 minutes) for APAP B.

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: ResMed
• Investigators: Principal Investigator: Ingo Fietz, Prof, Charite Center of Sleep Medicine

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: January 27, 2015
• First Submitted That Met QC Criteria: February 3, 2015
• First Posted (Estimate): February 6, 2015

Study Record Updates

• Last Update Posted (Actual): April 20, 2020
• Last Update Submitted That Met QC Criteria: April 8, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Acetaminophen
• Other Study ID Numbers: MA240115