This study aims to assess the effectiveness of an investigational algorithm in the treatment of obstructive sleep apnea.
Participants willing to give written informed consent.
Participants who can read and comprehend English.
Participants who ≥ 18 years of age
Participants who have been using a ResMed AirSense 10 or 11 device.
Participants using Bilevel flow generators.
Participants using CPAP, AutoSet for Her
Participants who are or may be pregnant.
Participants 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.
Crossover
Investigational algorithm
DeviceInvestigational algorithm developed for the treatment of Obstructive Sleep Apnea.
Control algorithm
DeviceReleased algorithm intended for the treament of Obstructive Sleep Apnea
Comparison of the algorithm efficacy (AHI) to a clinically relevant data
The mean residual AHI of the investigational algorithm will be compared against an excepted clinical benchmark of 5 using a one sample t test.
Secondary endpoint: Device usage
Hypothesis: the investigational algorithm will be equivalent or better than the comparison algorithm. Objective statistics on "Device usage" in hours per day (Hrs) stored in the PAP device will be downloaded. These parameters will be captured from each arm of testing and results will be analysed and compared.
Secondary endpoint: Leak
Hypothesis: the investigational algorithm will be equivalent or better than the comparison algorithm. Objective statistics on "Leak" in litres per minute (L/min) stored in the PAP device will be downloaded. These parameters will be captured from each arm of testing and results will be analysed and compared.
Secondary endpoint: Pressure
Hypothesis: the investigational algorithm will be equivalent or better than the comparison algorithm. Objective statistics on "Pressure" in centimeters of water (cmH2O) stored in the PAP device will be downloaded. These parameters will be captured from each arm of testing and results will be analysed and compared.
Secondary endpoint: Subjective scores
Hypothesis: the investigational algorithm will be equivalent or better than the comparison algorithm and/or Criterion score of 6. Subjective scores will be collected from participants on each item (e.g. comfort, breathign comfort, ease of falling asleep). Scores will be collected using an 11-point Likert Scale where a score of 10 is considered very favorable whereas score of 0 is considered very unfavorable.
