Comparison of Two Continuous Positive Airway Pressure Systems
NCT ID: NCT02535234
Last Updated: 2021-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2016-04-30
2016-06-30
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
NONE
Study Groups
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Arm 1
Participants randomised to Arm 1 will receive an intervention of 7 nights with the Novel system followed by 7 nights with theTraditional system
Novel System
A Novel full Continuous Positive Airway Pressure (CPAP) system - Prototype Device, Mask + Accessories
Traditional System
A Traditional full Continuous Positive Airway Pressure (CPAP) system- Released Device + Accessories, Prototype Mask
Arm 2
Participants randomised to Arm 1 will receive an intervention of 7 nights with the Traditional system followed by 7 nights with the Novel system
Novel System
A Novel full Continuous Positive Airway Pressure (CPAP) system - Prototype Device, Mask + Accessories
Traditional System
A Traditional full Continuous Positive Airway Pressure (CPAP) system- Released Device + Accessories, Prototype Mask
Interventions
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Novel System
A Novel full Continuous Positive Airway Pressure (CPAP) system - Prototype Device, Mask + Accessories
Traditional System
A Traditional full Continuous Positive Airway Pressure (CPAP) system- Released Device + Accessories, Prototype Mask
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participant is able to read and comprehend written and spoken English
* Participant is ≥ 18 years of age
* Participant has been diagnosed with Obstructive Sleep Apnoea (OSA)
* Participants has been established on Continuous Positive Airway Pressure (CPAP) for ≥ 6 months
* Participants is currently using the same mask type/variant as the interventional mask system to be evaluated
* Participants is able to participate for the duration of the study
Exclusion Criteria
* Participant is unable to read and comprehend written and spoken English
* Participant is \< 18 years of age
* Participant has not been diagnosed with Obstructive Sleep Apnoea (OSA)
* Participant has not been established on Continuous Positive Airway Pressure (CPAP) for ≥ 6 months
* Participant is not currently using the same mask type/variant as the interventional mask system to be evaluated
* Participant is unable to participate for the duration of the study
* Participant is pregnant
* Participant is established on bi-level support therapy
* Participant, or participants bed partner, has metallic implants in head neck or chest
* Participant has a with a pre-existing lung disease or a condition that would predispose them to pneumothorax (e.g. Chronic Obstructive Pulmonary Disease (COPD), lung cancer; fibrosis of the lungs; recent (\< 2years) case of pneumonia or lung infection, lung injury)
* Participant is unsuitable to participate in the study in the opinion of the researcher
18 Years
ALL
No
Sponsors
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ResMed
INDUSTRY
Responsible Party
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Principal Investigators
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Klaus Schindhelm
Role: PRINCIPAL_INVESTIGATOR
ResMed Limited
Holger Woehrle, MD
Role: PRINCIPAL_INVESTIGATOR
ResMed
Locations
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ResMed
Sydney, New South Wales, Australia
Countries
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References
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Peppard PE, Young T, Barnet JH, Palta M, Hagen EW, Hla KM. Increased prevalence of sleep-disordered breathing in adults. Am J Epidemiol. 2013 May 1;177(9):1006-14. doi: 10.1093/aje/kws342. Epub 2013 Apr 14.
Young T, Palta M, Dempsey J, Skatrud J, Weber S, Badr S. The occurrence of sleep-disordered breathing among middle-aged adults. N Engl J Med. 1993 Apr 29;328(17):1230-5. doi: 10.1056/NEJM199304293281704.
Young T, Peppard PE, Gottlieb DJ. Epidemiology of obstructive sleep apnea: a population health perspective. Am J Respir Crit Care Med. 2002 May 1;165(9):1217-39. doi: 10.1164/rccm.2109080.
Other Identifiers
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MA011015
Identifier Type: -
Identifier Source: org_study_id
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