None listed
Conditions
Brief summary
CPAP Therapy is the gold standard treatment for OSA, which has been proven to be extremely effective over the last 30 years. Adherence to therapy remains sub-optimal, and as such technological improvements to improve patient comfort and adherence, are continually being developed. The technological improvements need to be evaluated for comfort by the treatment population, in order to inform product development. These evaluations are to gauge acceptance and preference of one solution over another, before investing further development for a final product and assessing treatment efficacy.
Interventions
CPAP devices with modifications designed to increase patient comfort - to be trialled by subjects for comfort and preference only. 1. Two different devices will be trialled, each offering a different pressure control method (how stable the pressure is when breathing in and out). Device 1 will keep the pressure in the mask as low as possible. Device 2 will provide some pressure relief on expiration (in the region of 1-2cmH2O). 2.a) Subjects will breathe on the device while awake for short periods
CPAP devices with modifications designed to increase patient comfort - to be trialled by subjects for comfort and preference only. 1. Two different devices will be trialled, each offering a different pressure control method (how stable the pressure is when breathing in and out). Device 1 will keep the pressure in the mask as low as possible. Device 2 will provide some pressure relief on expiration (in the region of 1-2cmH2O). 2.a) Subjects will breathe on the device while awake for short periods of time (minimum of 2 minutes and < 30 minutes) b) Patients will be tested on a sub-therapeutic pressure (as they are awake and don't require treatment). This pressure is determined by the minimum pressure the device can produce whilst safely flushing CO2. c) All participants will try all devices. The wash-out period between devices will be at least half as long as the time spent breathing on the device (between one minute and 15 minutes). Different mask prototytpes will be trialled with CPAP while the patient is awake.
Sponsors
Fisher & Paykel Healthcare
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Aged 18 years or older Able to give informed consent (this study will include healthy volunteers, patients that are awaiting a sleep study with a suspicion of OSA, and patients diagnosed with OSA)
Exclusion criteria
Contraindicated for CPAP/AutoCPAP therapy Must not require supplemental oxygen Must not have critical medical device (i.e. cardiac pacemaker)
Outcome results
None listed