Evaluation of Treatment Efficacy and Comfort of a Modified Positive Airway Pressure Device to Treat Obstructive Sleep Apnea.
Evaluation of Treatment Efficacy and Comfort of a Modified Positive Airway Pressure Device to Treat Obstructive Sleep Apnea.
This study will test the hypothesis that the modified positive airway pressure (PAP) device
 for OSA will be no worse than a market released product in terms of its treatment efficacy,
 comfort and patient compliance. Patients will have their treatment pressure titrated using
 polysomnography (PSG) in the sleep laboratory, and then in a random order will spend
 additional time undergoing PSG using both devices, and using both devices at home for 3
 weeks. Data will be collected from the PSG studies, device downloads, independent
 pressure-flow loggers, and custom questionnaires.
The study will be held in two parts. The main portion of the study which compares the
 modified PAP device and the market released product including the laboratory testing and home
 testing of the devices will be called 'Part A'. Additional nights using the PAP device with
 PSG monitoring will be used to gather additional observational flow data to allow distortion
 testing and investigation of the FPH (Fisher & Paykel Healthcare) SensAwake (an unique
 feature which automatically lowers the pressure when a patient wakes up) algorithm while
 using PAP, this is part B.

 Part A After the patient has undergone informed consent, their demographic and clinical
 variables will be collected and entered into a case report form (CRF) before any setup
 procedure is started. The patient will be asked to complete questionnaires regarding their
 normal therapy (ESS (Epworth Sleepiness Score), FOSQ (Functional Outcomes of Sleep
 Questionnaire), custom therapy comfort questionnaire), and then will be set up for a standard
 PSG. The patient will use their prescribed mask and a clean water chamber and breathing tube
 which will be connected to the modified PAP device. The patients will sleep on the device
 throughout the night while having their PAP titrated by a qualified sleep technician.
 Pressure titration is necessary for two reasons: firstly, it may have been a period of time
 since the participants last titration, and secondly this version of PAP involves the use of
 different levels of pressure. Pressures will be titrated according to the AASM (American
 Academy of Sleep Medicine) Clinical Guidelines for the Manual Titration of Positive Airway
 Pressure in Patients with OSA.

 The participant will be randomized to either the modified PAP or market released device
 group. They will be issued with a PAP device and a pressure-flow logger to be used at home in
 the usual manner of their PAP therapy for 3 weeks (+/- 4 days), after which participants will
 return to the FPH sleep laboratory to participate in a overnight PSG study using their first
 device. At this visit the participant will also swap to the second PAP device; and the above
 home use repeated on device 2.

 Part B After informed consent form the patient will be set up for a standard PSG, and sleep
 overnight using the modified PAP device, their prescribed mask, and a clean water chamber and
 breathing tube. This testing will be performed to provide additional flow data to the
 development engineers. This includes, but is not limited to, distortion testing and
 adjustment of device parameters during the sleep study. Distortion testing analyses the
 impact of the PAP pressure changes on the participants breathing or airflow.
Inclusion Criteria:

 -  Aged 18+

 -  Diagnosed with OSA by a practicing sleep physician

 Exclusion Criteria:

 -  Patients with a known history of Cerebrospinal fluid leak, abnormalities of the
 cribriform plate, head trauma and/or pneumocephalus

 -  Patients with pathologically low blood pressure, pneumothorax, a previous history of
 pneumothorax, or dehydration.

 -  Patient with bypassed upper airway

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

 -  Previous use of a bi-level device with-in the last 2 years (from enrolment date).

 -  Patients with respiratory failure, bullous lung disease or COPD (Chronic Obstructive
 Pulmonary Disease).

 -  Patients with obesity hypoventilation syndrome or congestive heart failure

 -  Patients that require supplemental oxygen with their CPAP (Continuous Positive Airway
 Pressure) device

 -  Patients with implanted or life-supporting electronic medical devices (e.g. cardiac
 pacemakers)