None listed
Conditions
Brief summary
The adherence of the Racer system will be compared against standard positive airway pressure (PAP) machines in a group of naive PAP users. Patients will have been clinically recommended to begin PAP treatment for moderate to severe obstructive sleep apnoea (OSA). Following an initial level 1, 2 or 3 sleep study and PAP pressure auto-titration in the WellSleep lab, subjects will use either a continuous PAP (CPAP) device or RACer device for 8 weeks in their own home in a random order with a 3 day wash-out period between devices. Patients will use both the RACer and/or standard PAP therapy to determine which system has the greatest adherence over 4 weeks of use. Patients will visit the WellSleep lab every 2 weeks for follow-up appointments, which will involve an appointment with a sleep technician to problem solve any issues with the treatment that may arise, as well as to complete questionnaires relating to the comfort of each device, the participants sleepiness score and a short quality of life questionnaire.
Interventions
Participants will be randomly assigned to either the standard CPAP device or RACer airway device for the treatment of obstructive sleep apnoea. Arm 1: will involve 4 weeks using either of the medical devices at their home and include 2 follow up appointments in the lab. Arm 2: will involve another 4 weeks of treatment on the other device that was not used in arm 1 and again include 2 follow up appointments at the lab. There will be a 3-day washout period between arms. The RACer device combines t
Participants will be randomly assigned to either the standard CPAP device or RACer airway device for the treatment of obstructive sleep apnoea. Arm 1: will involve 4 weeks using either of the medical devices at their home and include 2 follow up appointments in the lab. Arm 2: will involve another 4 weeks of treatment on the other device that was not used in arm 1 and again include 2 follow up appointments at the lab. There will be a 3-day washout period between arms. The RACer device combines two commercially available CPAP machine motors into 1 unit to deliver pressurised air into the upper airway into 1 nostril at a time. This is different to conventional PAP machines. Participants will use the RACer device the same as they use a standard PAP device, however they must use a nasal pillow mask as an interface for the pressurised air. Participants will use the RACer device at night, as a treatment for their sleep apnoea, for the entire 4 week period. RACer device settings will be entered for each individual participant following their initial sleep study and could be in a pressure range from 8 - 20 cm/H2O. The RACer device will objectively monitor usage each night, as well as AHI, and these will be downloaded at each follow up appointment.
Sponsors
Auckland University of Technology (AUT) Enterprises Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Adults (aged 18-70) , naive to PAP therapy, able to tolerate a nasal pillow mask type, moderate to severe OSA defined by an AHI or RDI of > 20 events per hour on a diagnostic sleep study (L 1, 2 or 3).
Exclusion criteria
Blood thinning medication, nasal obstruction, unable to tolerate nasal pillow mask type, excessive daytime sleepiness or safety critical occupation, unstable co-morbid medical conditions including heart failure, respiratory failure, arrhythmia, previous cerebrovascular accident.
Outcome results
None listed