Clinical trial NCT02535234: Comparison of Two Continuous Positive Airway Pressure Systems
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnoea
Lead sponsor: ResMed
Sponsor class: INDUSTRY
First posted: 2015-08-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Randomised crossover trial of a novel and traditional Continuous Positive Airway Pressure (CPAP) system in Obstructive Sleep Apnoea patients.


Eligibility criteria: Inclusion Criteria

* 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

Exclusion Criteria

* 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

Primary outcomes:
measure: Subjective usability ratings of the prototype system using a visual analogue scale, compared to a reference level and the second full system.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: ResMed
state: New South Wales
Study officials:
affiliation: ResMed Limited
name: Klaus Schindhelm
role: PRINCIPAL_INVESTIGATOR
affiliation: ResMed
name: Holger Woehrle, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.