User Preference/Validation Evaluation of the New Philips Respironics Positive Airway Pressure Application

Study Overview
=================
Brief 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: 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. 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. 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.

Official Title
-----------------
User Preference/Validation Evaluation of the New Philips Respironics Positive Airway Pressure Application

Conditions
-----------------
Sleep Disordered Breathing

Intervention / Treatment
-----------------
* Other: Standard of Care
* Device: DreamMapper Application
* Device: DreamMapper Application with Therapist Assist


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 21-75 Diagnosis of Obstructive Sleep Apnea (OSA) with an Apnea Hypopnea Index (AHI) of at least 15 events/hour of sleep and a Central Apnea Index (CAI) ≤ 5 events /hour or ≤ 50% of the AHI. Newly diagnosed and Continuous Positive Airway Pressure (CPAP) Naïve. Currently owns and uses apps on an Android or iPhone smart phone. Willing to undergo an attended in lab Polysomnography (PSG) Willing and able to provide informed consent. Speaks and reads English as their primary language. Exclusion Criteria: Presence of poorly managed or unstable major medical or psychiatric conditions that would interfere with the demands of the study, adherence to positive airway pressure, or the ability to complete the study. For example, unstable congestive heart failure, chronic lung disease with daytime hypercapnia, neuromuscular disease, psychiatric disease, cancer, or chronic renal failure. Participants who are unwilling to try Positive Airway Pressure (PAP) therapy. Participants currently prescribed oxygen therapy (as needed, nocturnal, or continuous). Participants with previously diagnosed respiratory failure or respiratory insufficiency. Recent surgery of the upper airway, noise, sinus, or eyes. Participant is prescribed a BiPAP device Commercial Drivers Shift workers Participants with untreated periodic limb movement syndrome, or restless legs syndrome (PLM Arousal Index > 15). Participants with untreated known diagnosis of Insomnia (score of 15-21(moderate severity) per Insomnia Severity Index (ISI) ) Known diagnosis of bipolar disorder Participant with unstable anti- depressant medication (not stable for 3 months)

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of Care<br>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. Therapy information is available continuously to site staff personnel in the standard care arm. | Other: Standard of Care<br>* 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.<br>|
| Experimental: DreamMapper Application<br>The DreamMapper Application 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 | Device: DreamMapper Application<br>* 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.<br>|
| Experimental: DreamMapper Application with Therapist Assist<br>The DreamMapper Application wit Therapist Assist 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 | Device: DreamMapper Application with Therapist Assist<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| User Preference of the New Philips Respironics Positive Airway Pressure Application as Measured by the Attitudes Toward Use Questionnaire | Participants will complete the Attitudes Toward Use Questionnaire (0 to 10 scale) to determine user preference of the New Philips Respironics Positive Airway Pressure Application. The higher the value the higher participant confidence. | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence | Adherence will be measured among the three groups to determine which participants used their Positive Airway Pressure device most throughout the trial: DreamMapper compared to site standard of care compared to using DreamMapper and Therapist Assist. | 90 days | 
| Treatment Outcomes - Epworth Sleepiness Scale | Treatment outcomes will be assess by the Epworth Sleepiness Scale. The Epworth Sleepiness is 8 question survey asking questions about likelihood to fall asleep, each questions is answered on a 0 to 3 scale, 0-no chance, 3-high chance, the higher the score the higher likelihood of daytime sleepiness. The scale is 0-24, 0-no chance to fall asleep. | 90 days | 
| Treatment Outcomes - Functional Outcomes of Sleep Questionnaire (FOSQ) | Treatment outcomes will be assess by the Functional Outcomes of Sleep Questionnaire. The FOSQ is a specific quality of life questionnaire to determine functional status in adults; measures are designed to assess the impact of disorders of excessive sleepiness on multiple activities of everyday living and the extent to which these abilities are improved by effective treatment. It asks sets of questions for activity level, vigilance, intimacy and sexual relationships, general productivity, social outcome, rate the difficulty of performing a given activity on a 4-point scale (4-no difficulty to 1-extreme difficulty 0-I do not do it for other reasons). 10 questions are asked with the lowest score of 0 and the highest of score of 40. The lower the score the more difficulty it is to complete tasks. | 90 days | 
| Site Economic Savings Assessed by Number of Phone Calls. | Site economics savings will be collected and analyzed by reviewing the number of phone calls per arm. Exact numeric amounts of savings are not available but number of calls is. | 90 days | 
| Patient Interactions | Site and patient interactions will be assessed after 90 days by reviewing the exact number of unscheduled visits in each arm. | 90 days | 
| Mask Refits | Number of patient visits requiring mask refits will be measured and recorded. The exact number of mask refits will be provided. | 90 days | 
| Overall Economic Cost Saving | Analysis will be done on the overall economic cost savings from Therapist Assist and DreamMapper | 90 days |