Evaluation of Treatment Efficacy and Comfort of a Modified Positive Airway Pressure Device to Treat Obstructive Sleep Apnea.
Condition: Obstructive Sleep Apnea (OSA)
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): PAP device
Intervention type(s): Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment