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
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
MA17082018 (2018-2023): • Patients willing to give written informed consent • Patients who can read and comprehend English • Patients who >/= 18 years of age • Patients being treated for OSA for >/= 6 months • Patients currently using a suitable mask system • Patients who can trial the masks for up to 7 nights each SLP-23-04-02 (2023-2028): • Participants willing to give written informed consent • Participants who >/= 18 years of age • Participants being treated for OSA for >/= 3 months • Participants currently using a suitable mask system(s) • Participants who can trial the masks for up to 7 nights each
Exclusion criteria
MA17082018 (2018-2023): • 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) SLP-23-04-02 (2023-2028): • Patients using Bilevel flow generators • Patients who are 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 • Patients 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) • Patients who are currently enrolled in other clinical studies
Outcome results
None listed