This investigation is designed to evaluate the at-home usability, performance, user acceptance and reliability of the headgear with a CPAP mask for a duration of 6 months.
20 participants will be recruited for the trial, consisting of male and female participants diagnosed with OSA and receiving CPAP or Bi-level Positive airway pressure (PAP) for the treatment of their Obstructive Sleep Apnea (OSA). These include current CPAP mask users.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
20
Investigative Headgear with CPAP mask
Fisher & Paykel Healthcare
Auckland, New Zealand
Reliability of the headgear using a Questionnaire
Assessment of headgear properties on a monthly basis via custom questionnaire via phone call
Time frame: Monthly over a period of 6 months
Durability of the headgear by testing
Assessment of headgear properties on a monthly basis, and changes to the headgear
Time frame: Monthly over a period of 6 months
Performance in regards to leak of the headgear
Objective Leak Data (L/min) from the device download
Time frame: Monthly over a period of 6 months
Performance in regards to comfort of the headgear
Custom Questionnaire
Time frame: Monthly over a period of 6 months
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