User Preference/Validation Evaluation of the New Philips Respironics Positive Airway Pressure Application
Condition: Sleep Disordered Breathing
MeSH terms: Sleep Apnea Syndromes
Study type: Interventional

Summary: 
      This pilot study is intended to evaluate the acceptance and performance of the DreamMapper
      application and the Therapist Assist educational tool in naïve patients with Obstructive
      Sleep Apnea who have been prescribed Positive Airway Pressure therapy. A total of
      approximately 60 naïve participants will be recruited.
    

Detailed description: 
      This is a randomized prospective trial designed to obtain subjective and objective feedback
      in a home use environment with participants using a Philips Respironics System One Positive
      Airway Pressure device. Participants will be randomly assigned to one of three methods of
      therapy introduction and monitoring:

        1. Group 1: The first group, the control condition, participants will receive the sites
           therapy initiation standard of care for setting up and educating the participants on
           their Obstructive Sleep Apnea, mask, and device information. This group will use a
           wireless modem that is attached to the Positive Airway Pressure device and uploads
           adherence and other therapy information daily to a secured database (Encore Anywhere).
           With this method, therapy information is not directly available to the participant.
           Therapy information is available continuously to site staff personnel in the standard
           care arm.

        2. Group 2: The second group will receive the site's therapy initiation standard of care
           for setting up and educating the participants on their Obstructive Sleep Apnea, mask,
           and device information. Participants in this group will also download the DreamMapper
           application on their iPhone or Android smart phone. Therapy information and educational
           material will be available continuously to the participant with DreamMapper through the
           application. Study personnel will have access to adherence and therapy information
           continuously as well.

        3. Group 3: The third group will not receive the site's therapy initiation standard of care
           but will review the Therapist Assist automated educational material on Obstructive Sleep
           Apnea, and their Philips Respironics mask. and DreamMapper. These participants will
           download the DreamMapper application onto their iPhone or Android smart phone. Therapy
           information and educational material will be available continuously to the participant
           with DreamMapper. Study personnel will have access to adherence and therapy information
           continuously as well.
    

Intervention name(s): Standard of Care; DreamMapper Application; DreamMapper Application with Therapist Assist
Intervention type(s): Other; Device; Device
Intervention description(s): In the standard of care or the control condition, participants will receive the sites therapy initiation standard of care for setting up and educating the participants on their Obstructive Sleep Apnea, mask, and device information. This group will use a wireless modem that is attached to the PAP device and uploads adherence and other therapy information daily to a secured database (Encore Anywhere). With this method, therapy information is not directly available to the participant but will continuously be available to site staff personnel.; The DreamMapper application condition will receive the site's therapy initiation standard of care and will also download the DreamMapper application on their iPhone or Android smart phone. Therapy information and educational material will be available continuously to the participant with DreamMapper through the application. Study personnel will have access to adherence and therapy information continuously.; The DreamMapper with Therapist Assist will review the Therapist Assist automated educational material on Obstructive Sleep Apnea, their Philips Respironics mask and DreamMapper. These participants will download the DreamMapper application onto their iPhone or Android smart phone. Therapy information and educational material will be available continuously to the participant with DreamMapper. Study personnel will have access to adherence and therapy information continuously.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care