Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Fisher and Paykel Healthcare
This study will involve three visits to the investigation site. During visit one participants will be randomized to, fitted with and issued with the first trial mask seal for use in- home for 7 ±4 days.
The participants will then come in to return the mask seal and be fitted and issued with the second trial seal for use in home for 7±4 days.
Visit Three will involve the participants returning the second trial seal and providing feedback.
Age
22–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Adult (22+ years of age)
Able to give informed consent
Apnea hypopnea Index (AHI) ≥ 5 on diagnostic night
Either prescribed Automatic positive airway pressure (APAP), Continuous positive airway pressure (CPAP) or Bi-level positive airway pressure (PAP) for OSA
Fluent in spoken and written English
Existing F\&P full face mask user
You may not be if
Inability to give informed consent
Participant intolerant to PAP
Anatomical or physiological conditions making PAP therapy inappropriate
Current diagnosis of respiratory disease or carbon Dioxide (CO2) retention
Pregnant or may think they are pregnant.
Clareo Health | The Evaluation of a Full Face Mask Seal for the Treatment of Obstructive Sleep Apnea
