None listed
Conditions
Brief summary
Prototype CPAP masks will be evaluated for usability (comfort, seal and stability) by participants for a 7 night period. During the process of product development, multiple user trials are conducted in order to improve CPAP masks. The purpose of this study is to identify usability issues and improve them in order to develop CPAP masks which are comfortable and easy to use.
Interventions
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
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. 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. 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
Inclusion Criteria (MA17082018) • Participants who are employees of ResMed • Participants who are willing to give written informed consent (signed paper copy or via DocuSign) • Participants that are willing and able to complete the specified tasks • Participants who are at least 18 years of age Inclusion Criteria (SLP-23-04-02): • Participants who are employees of ResMed • Participants willing to give written informed consent • Participants who > or = 18 years of age • Participants willing and able to complete the specified tasks
Exclusion criteria
Exclusion Criteria (MA17082018): • Patients using Bilevel flow generators • Patients who are or may be pregnant • Patients with a preexisting 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 believed to be unsuitable for inclusion by the researcher • Participants who or whose bed partner has implantable metallic implants in the head, neck and chest region affected by magnetic fields (Non-ferrous implants may be acceptable) (for masks with magnetic clips only) Exclusion Criteria (SLP-23-04-02): • Participants who are or may be pregnant • Participants 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 • Participants who or whose bed partner has implantable medical devices which may contraindicate against masks with magnetic clips (exclusion criteria for study masks with magnetic clips only)
Outcome results
None listed