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. ResMed teams are constantly designing potential new products. At times it is desirable for internal staff members to volunteer to trial prototypes of masks, frames, headgears and accessories because: employees may wish to assess a design to experience how it works and feels, and determine ways to improve it; there may be a need to gain initial feedback on whether an idea is worth pursuing; design team wishes to narrow down options before proceeding to a user trial on OSA patients.
Interventions
A variety of unregistered prototype CPAP masks will be used as the intervention in this study. The number of intervention masks that an individual 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). Participants will also use an approved CPAP machine and humidifier with the prototype mask. CPAP pressure will be set to
A variety of unregistered prototype CPAP masks will be used as the intervention in this study. The number of intervention masks that an individual 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). Participants will also use an approved CPAP machine and humidifier with the prototype mask. CPAP pressure will be set to 12cmH2O or to a pressure that the participant feels most comfortable. Humidifier settings will be set to a level each participant feels most comfortable with. 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 that may be evaluated will not be known at the beginning of the study, but will be reported at the completion of the study. ResMed teams are constantly designing potential new products. At times it is desirable for internal staff members to volunteer to trial prototypes of masks, frames, headgears and accessories because: employees may wish to assess a design to experience how it works and feels, and determine ways to improve it; there may be a need to gain initial feedback on whether an idea is worth pursuing; design team wishes to narrow down options before proceeding to a user trial on OSA patients. The sample size is the approximate sample size that will be recruited per prototype trial. All CPAP masks will be used for a minimum of 3 nights and a maximum of 7 nights each. 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
Yes
Inclusion criteria
Participants have been trained in The Rights and Responsibilities of Trial Participants Participants willing to give written informed consent Participants who are able to comprehend written and spoken English Participants that are willing and able to complete the specified follow up evaluations Participants who are at least 18 years of age
Exclusion criteria
Participants who are not able to provide written informed consent Participants who are unable to comprehend written and spoken English Participants who are unable to commit to the duration of the trial Participant is a design engineer directly involved with designing the prototype being trialled Participants 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. Participants who are unsuitable for inclusion in the opinion of the investigator
Outcome results
None listed