Comparison of Auto-Adjusting Positive Airway Pressure Devices

Obstructive Sleep Apnea Clinical Trial

Official title:

Comparison of Auto-Adjusting Positive Airway Pressure Devices

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02357706
• Other study ID #: MA240115
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: December 2015

Study information

• Verified date: April 2020
• Source: ResMed
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Intervention

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
• 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

Locations

Country	Name	City	State
Germany	Center of Sleep Medicine, Charité - Universitätsmedizin Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
ResMed

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Mean O2 Saturation	Mean blood oxygen Saturation, %	1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B