This study will take between 4-6 months (with first patient first visit to last patient last visit expected to span 3-4 months across all study sites). Each participant will use the investigational PAP device with their own mask for a period of up to 7 nights and will complete a series of questionnaires upon completion. The study will evaluate the usability and efficacy of the investigational device in the intended use environment by the intended use population.
A new PAP device has been developed by ResMed which includes an improved humidification system, a new user interface and optimized workflows. This study will assess the efficacy and usability of the new PAP device in an OSA population. This is a prospective, open-label, single arm study, multi-site study to assess the usability and efficacy of investigational device in the home environment. Recruitment Recruitment will be done via phone calls/ SMS messages/ emails. Participants will be explained the details of the study and those who wish to take part will be invited to a ResMed clinic or selected site for the first study visit (As detailed in section 7). Visit 1 Participants will provide written informed consent (as per section 6.1). If eligible, baseline participant demographics will be collected. Participants will be shown the investigation device. If the participant is happy to proceed the investigational device will be set-up to be exactly the same as their current CPAP device, and the participant will take it home to use in place of their own device. Visit 2 At the conclusion of the 7 nights of use, the participant will be asked to fill in a questionnaire documenting their experience with the investigational device. The participant will return all study equipment to the researcher. The questionnaires will be reviewed. This concludes the participation in the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
108
PAP therapy supplies pressurized air from the flow generator to the upper airway via air tubing and a mask to prevent the repetitive collapse of the upper airway during sleep.
Sleep Data
San Diego, California, United States
ResMed BELLA VISTA
Sydney, New South Wales, Australia
Usability
Subjective ratings of the Usability of the Pacific device after using it in the home environment for up to 7 nights. Ratings will be collected using an 11 point Likert Scale where a score of 10 is considered very favorable, and a score of 0 is very unfavorable.
Time frame: 1 week
Apnea Hypopnea Index (AHI)
Number of residual Apnea Hypopnea events within a clinically acceptable range when using the Pacific device in the home environment for a up to 7 nights.
Time frame: 1 week
Usage-Positive Airway Pressure (PAP) Device parameters
Average number of hours per night of use of the Pacific Device during sleep sessions from up to 7 nights
Time frame: 1 week
Leak-Positive Airway Pressure (PAP) Device parameters
Average median, 95 percentile and maximum leak(L/min) while using the Pacific device from up to 7 nights
Time frame: 1 week
Pressure-Positive Airway Pressure (PAP) Device parameters
Average pressure delivered by the Pacific device between 4cmH2O-20cmH2O from use up to 7 nights
Time frame: 1 week
Acoustic Signals
Cross-correlation of the acoustic signals recorded from the patient environment and the external recording in the controlled laboratory environment identification algorithm.
Time frame: 1 week
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