Comparison of Auto-Adjusting Positive Airway Pressure Devices
NCT ID: NCT02357706
Last Updated: 2020-04-20
Study Results
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View full resultsBasic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2015-01-31
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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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.
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
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.
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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)
18 Years
MALE
No
Sponsors
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ResMed
INDUSTRY
Responsible Party
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Principal Investigators
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Ingo Fietz, Prof
Role: PRINCIPAL_INVESTIGATOR
Charite Center of Sleep Medicine
Locations
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Center of Sleep Medicine, Charité - Universitätsmedizin Berlin
Berlin, , Germany
Countries
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Other Identifiers
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MA240115
Identifier Type: -
Identifier Source: org_study_id
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