None listed
Conditions
Brief summary
Obstructive sleep apnoea (OSA) is characterised by a partial or complete collapse of the upper airway during sleep. Continuous Positive Airway Pressure (CPAP) therapy acts as a positive airway splint, delivering a fixed positive airway pressure to the upper airway via a tube and mask. CPAP compliance is strongly influenced by the patient’s mask system. As masks are worn every night the comfort, seal, stability and ease of use of a CPAP mask is highly important. The product development of mask systems is an iterative process. Evaluation of the comfort, seal, stability and ease of use of the mask system by patients in their home environment provides the required information for these iterative design changes. This project will allow the iterative testing of mask systems by patients by comparing them to already released masks or acceptable subjective levels.
Interventions
A variety of unregistered prototype CPAP masks will be used as the intervention in this study. The number of intervention masks a participant may test will range from 1 to 2 masks. There will be no washout period between masks. CPAP masks may be full face, nasal, or nasal pillows masks (covering mouth and nose, covering nose only, or inserted into nostrils). As this study protocol aims to facilitate the product development of CPAP masks (an iterative process), this protocol allows for a prototype mask to be designed, used as a trial intervention, improved based on patient feedback, and then retested again as trial intervention. This process may occur for several cycles. This particular protocol also allows for the testing of several different prototype masks. As such, the total number of intervention masks being evaluated under this protocol at the beginning of the study is unknown, but will reported at the completion of the study. All CPAP masks will be used for a minimum of 3 nights and a maximum of 7 nights. Other than 'mask type' setting, patient's CPAP therapy settings will not be changed. Adherence will be monitored through data downloads directly from the patient's device or SD card. Adherence may also be monitored through an approved wireless therapy monitoring system (EasyCare Online).
Sponsors
ResMed Ltd
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients willing to give written informed consent Patients who are able to comprehend written and spoken English Patients who have been diagnosed with OSA Patients who are established CPAP therapy users Patients who are at least 18 years of age Patients who are using an appropriate current mask system and size for the particular study
Exclusion criteria
Patients who are not able to provide written informed consent Patients who are unable to comprehend written and spoken English Patients who are not using an appropriate current mask system and size for the particular study Patients who are pregnant Patients with 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. Patients who are unsuitable for inclusion in the opinion of the investigator
Outcome results
None listed