Comparison of Two Continuous Positive Airway Pressure Systems
Comparison of the Subjective and Objective Performance of a Novel Continuous Positive Airway Pressure (CPAP) System With a Traditional Continuous Positive Airway Pressure (CPAP) System.
1 other identifier
interventional
30
1 country
1
Brief Summary
Randomised crossover trial of a novel and traditional Continuous Positive Airway Pressure (CPAP) system in Obstructive Sleep Apnoea patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 25, 2015
CompletedFirst Posted
Study publicly available on registry
August 28, 2015
CompletedStudy Start
First participant enrolled
April 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedFebruary 4, 2021
February 1, 2021
2 months
August 25, 2015
February 2, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Subjective usability ratings of the prototype system using a visual analogue scale, compared to a reference level and the second full system.
Participants will be asked to complete a short questionnaire at the end of each week to evaluate the general usability of the system. The questionnaire will include questions related to system use and comfort. The participants will answer the questions using an 11-point Likert scale.
1 year
Study Arms (2)
Arm 1
ACTIVE COMPARATORParticipants randomised to Arm 1 will receive an intervention of 7 nights with the Novel system followed by 7 nights with theTraditional system
Arm 2
ACTIVE COMPARATORParticipants randomised to Arm 1 will receive an intervention of 7 nights with the Traditional system followed by 7 nights with the Novel system
Interventions
A Novel full Continuous Positive Airway Pressure (CPAP) system - Prototype Device, Mask + Accessories
A Traditional full Continuous Positive Airway Pressure (CPAP) system- Released Device + Accessories, Prototype Mask
Eligibility Criteria
You may qualify if:
- Participant is willing to provide written informed consent
- 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
You may not qualify if:
- Participant is not willing to provide written informed consent
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ResMedlead
Study Sites (1)
ResMed
Sydney, New South Wales, 2153, Australia
Related Publications (3)
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.
PMID: 23589584RESULTYoung 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.
PMID: 8464434RESULTYoung 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.
PMID: 11991871RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Klaus Schindhelm
ResMed Limited
- PRINCIPAL INVESTIGATOR
Holger Woehrle, MD
ResMed
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2015
First Posted
August 28, 2015
Study Start
April 1, 2016
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
February 4, 2021
Record last verified: 2021-02