Evaluation of Treatment Efficacy of a Modified Positive Airway Pressure Device to Treat Obstructive Sleep Apnea
Evaluation of Treatment Efficacy of a Modified Positive Airway Pressure Device to Treat Obstructive Sleep Apnea
This study will investigate the efficacy of the FPH modified positive airway pressure (PAP)
 device with or without SensAwake; and with different pressure support in OSA participants; in
 both an in-home and in-lab environment. Comfort, compliance and the accuracy of the pressure
 delivery will also be evaluated. The FPH device will be compared to a market released
 product.
Inclusion Criteria:

 -  Aged 18 and over

 -  Diagnosed with OSA by a practicing physician and prescribed Positive Airway Pressure
 (PAP) - (Continuous Positive Airway Pressure (CPAP) or AutoCPAP). Participants can be
 naïve to CPAP or experienced users of CPAP.

 -  For experienced users of PAP (CPAP or AutoCPAP): Using the PAP of more than 4
 hours/night for 70% during the last 30 days (justification allowed by the
 investigator)

 Exclusion Criteria:

 -  Contraindicated for PAP (CPAP or AutoCPAP) therapy

 -  Persons with other significant sleep disorder(s) (e.g periodic leg movements,
 insomnia, central sleep apnea)

 -  Persons with obesity hypoventilation syndrome or congestive heart failure.

 -  Persons that require supplemental oxygen with their PAP (CPAP or AutoCPAP) device

 -  Persons with implanted electronic medical device (e.g cardiac pacemakers)

 -  Persons who are pregnant or think they might be pregnant.