Trial Outcomes & Findings for User Preference/Validation Evaluation of the New Philips Respironics Positive Airway Pressure Application (NCT NCT03748264)

Last Updated: 2021-03-12

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

62 participants

Primary outcome timeframe

90 days

Results posted on

2021-03-12

Participant Flow

Participant milestones

Participant milestones
Measure	Standard of Care All participants enrolled in to the Standard of care.	DreamMapper Application All participants that were enrolled into the DreamMapper Application.	DreamMapper Application With Therapist Assist All participants that were enrolled into the DreamMapper Application With Therapist Assist.
Overall Study STARTED	21	21	20
Overall Study COMPLETED	21	21	20
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard of Care n=21 Participants All participants that were enrolled into the Standard of Care.	DreamMapper Application n=21 Participants All participants that were enrolled into the DreamMapper Application.	DreamMapper Application With Therapist Assist n=20 Participants All participants that were enrolled into the DreamMapper Application With Therapist Assist.	Total n=62 Participants Total of all reporting groups
Age, Continuous	46.8 years STANDARD_DEVIATION 11.4 • n=5 Participants	46.9 years STANDARD_DEVIATION 11.1 • n=7 Participants	47.3 years STANDARD_DEVIATION 10.0 • n=5 Participants	47.0 years STANDARD_DEVIATION 10.7 • n=4 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	9 Participants n=7 Participants	11 Participants n=5 Participants	28 Participants n=4 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	12 Participants n=7 Participants	9 Participants n=5 Participants	34 Participants n=4 Participants
Region of Enrollment United States	21 Participants n=5 Participants	21 Participants n=7 Participants	20 Participants n=5 Participants	62 Participants n=4 Participants
Body Mass Index (BMI)	37.8 kg/m^2 STANDARD_DEVIATION 8.5 • n=5 Participants	36.4 kg/m^2 STANDARD_DEVIATION 6.6 • n=7 Participants	33.7 kg/m^2 STANDARD_DEVIATION 5.1 • n=5 Participants	36.0 kg/m^2 STANDARD_DEVIATION 7.0 • n=4 Participants

PRIMARY outcome

Timeframe: 90 days

Population: All participants completed the study but not all participants completed the questionnaire for day 90. 6 standard of care participants did not complete the survey, 3 dreammapper and 1 dreammapper application with therapy assist did not complete the survey.

Outcome measures

Outcome measures
Measure	Standard of Care n=15 Participants 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. Standard of Care: 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.	DreamMapper Application n=18 Participants 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 DreamMapper Application: 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.	DreamMapper Application With Therapist Assist n=19 Participants 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 DreamMapper Application with Therapist Assist: 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.
User Preference of the New Philips Respironics Positive Airway Pressure Application as Measured by the Attitudes Toward Use Questionnaire	7.5 units on a scale Standard Deviation 3.6	7.9 units on a scale Standard Deviation 2.6	8.8 units on a scale Standard Deviation 1.5

SECONDARY outcome

Timeframe: 90 days

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.

Outcome measures

Outcome measures
Measure	Standard of Care n=21 Participants 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. Standard of Care: 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.	DreamMapper Application n=21 Participants 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 DreamMapper Application: 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.	DreamMapper Application With Therapist Assist n=20 Participants 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 DreamMapper Application with Therapist Assist: 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.
Adherence	4.6 days per week Standard Deviation 2.4	4.8 days per week Standard Deviation 1.7	4.0 days per week Standard Deviation 2.5

SECONDARY outcome

Timeframe: 90 days

Population: All participants completed the study but not all participants completed the questionnaire for day 90. 5 standard of care participants did not complete the survey, 2 dreammapper and 1 dreammapper application with therapy assist did not complete the survey.

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.

Outcome measures

Outcome measures
Measure	Standard of Care n=16 Participants 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. Standard of Care: 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.	DreamMapper Application n=19 Participants 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 DreamMapper Application: 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.	DreamMapper Application With Therapist Assist n=19 Participants 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 DreamMapper Application with Therapist Assist: 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.
Treatment Outcomes - Epworth Sleepiness Scale	6.4 units on a scale Standard Deviation 4.0	7.9 units on a scale Standard Deviation 6.1	7.7 units on a scale Standard Deviation 4.8

SECONDARY outcome

Timeframe: 90 days

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.

Outcome measures

Outcome measures
Measure	Standard of Care n=16 Participants 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. Standard of Care: 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.	DreamMapper Application n=19 Participants 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 DreamMapper Application: 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.	DreamMapper Application With Therapist Assist n=19 Participants 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 DreamMapper Application with Therapist Assist: 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.
Treatment Outcomes - Functional Outcomes of Sleep Questionnaire (FOSQ)	15.9 units on a scale Standard Deviation 4.4	16.0 units on a scale Standard Deviation 4.0	17.6 units on a scale Standard Deviation 2.0

SECONDARY outcome

Timeframe: 90 days

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.

Outcome measures

Outcome measures
Measure	Standard of Care n=21 Participants 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. Standard of Care: 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.	DreamMapper Application n=21 Participants 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 DreamMapper Application: 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.	DreamMapper Application With Therapist Assist n=20 Participants 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 DreamMapper Application with Therapist Assist: 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.
Site Economic Savings Assessed by Number of Phone Calls.	6 number of phone calls	7 number of phone calls	9 number of phone calls

SECONDARY outcome

Timeframe: 90 days

Site and patient interactions will be assessed after 90 days by reviewing the exact number of unscheduled visits in each arm.

Outcome measures

Outcome measures
Measure	Standard of Care n=21 Participants 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. Standard of Care: 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.	DreamMapper Application n=21 Participants 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 DreamMapper Application: 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.	DreamMapper Application With Therapist Assist n=20 Participants 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 DreamMapper Application with Therapist Assist: 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.
Patient Interactions	2 number of unscheduled visits	3 number of unscheduled visits	4 number of unscheduled visits

SECONDARY outcome

Timeframe: 90 days

Number of patient visits requiring mask refits will be measured and recorded. The exact number of mask refits will be provided.

Outcome measures

Outcome measures
Measure	Standard of Care n=21 Participants 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. Standard of Care: 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.	DreamMapper Application n=21 Participants 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 DreamMapper Application: 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.	DreamMapper Application With Therapist Assist n=20 Participants 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 DreamMapper Application with Therapist Assist: 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.
Mask Refits	2 number of refits	2 number of refits	3 number of refits

SECONDARY outcome

Timeframe: 90 days

Population: Unable to be analyzed based upon site confidential information.

Analysis will be done on the overall economic cost savings from Therapist Assist and DreamMapper

Outcome measures

Outcome data not reported

Adverse Events

Standard of Care

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

DreamMapper

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

DreamMapper Application With Therapist Assist

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Standard of Care n=21 participants at risk 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.Standard of Care: 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.	DreamMapper n=21 participants at risk 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 wellDreamMapper Application: 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.	DreamMapper Application With Therapist Assist n=20 participants at risk 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 wellDreamMapper Application with Therapist Assist: 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.
Immune system disorders Influenza	4.8% 1/21 • Number of events 1 • 90 days	0.00% 0/21 • 90 days	0.00% 0/20 • 90 days

Other adverse events

Other adverse events
Measure	Standard of Care n=21 participants at risk 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.Standard of Care: 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.	DreamMapper n=21 participants at risk 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 wellDreamMapper Application: 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.	DreamMapper Application With Therapist Assist n=20 participants at risk 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 wellDreamMapper Application with Therapist Assist: 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.
Skin and subcutaneous tissue disorders Irritated nostrils	0.00% 0/21 • 90 days	4.8% 1/21 • Number of events 1 • 90 days	0.00% 0/20 • 90 days
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/21 • 90 days	0.00% 0/21 • 90 days	5.0% 1/20 • Number of events 1 • 90 days
Metabolism and nutrition disorders Weight Gain	4.8% 1/21 • Number of events 1 • 90 days	0.00% 0/21 • 90 days	0.00% 0/20 • 90 days
Respiratory, thoracic and mediastinal disorders Dry Upper Airway	4.8% 1/21 • Number of events 1 • 90 days	0.00% 0/21 • 90 days	5.0% 1/20 • Number of events 2 • 90 days
Respiratory, thoracic and mediastinal disorders Nasal irritation	14.3% 3/21 • Number of events 3 • 90 days	4.8% 1/21 • Number of events 1 • 90 days	0.00% 0/20 • 90 days
Respiratory, thoracic and mediastinal disorders Shortness of breath	4.8% 1/21 • Number of events 1 • 90 days	0.00% 0/21 • 90 days	0.00% 0/20 • 90 days
Respiratory, thoracic and mediastinal disorders Adult Asthma	4.8% 1/21 • Number of events 1 • 90 days	0.00% 0/21 • 90 days	0.00% 0/20 • 90 days
Respiratory, thoracic and mediastinal disorders Bronchitis	0.00% 0/21 • 90 days	4.8% 1/21 • Number of events 1 • 90 days	0.00% 0/20 • 90 days
Respiratory, thoracic and mediastinal disorders Sinus Infection	0.00% 0/21 • 90 days	4.8% 1/21 • Number of events 1 • 90 days	0.00% 0/20 • 90 days
Respiratory, thoracic and mediastinal disorders Common Cold	0.00% 0/21 • 90 days	4.8% 1/21 • Number of events 1 • 90 days	0.00% 0/20 • 90 days
Ear and labyrinth disorders Right Ear Infection	4.8% 1/21 • Number of events 1 • 90 days	0.00% 0/21 • 90 days	0.00% 0/20 • 90 days
Musculoskeletal and connective tissue disorders Broken bone right 4th finger	0.00% 0/21 • 90 days	0.00% 0/21 • 90 days	5.0% 1/20 • Number of events 1 • 90 days
Respiratory, thoracic and mediastinal disorders Upper respiratory infection	0.00% 0/21 • 90 days	4.8% 1/21 • Number of events 1 • 90 days	0.00% 0/20 • 90 days
Skin and subcutaneous tissue disorders Impression on face	4.8% 1/21 • Number of events 1 • 90 days	0.00% 0/21 • 90 days	0.00% 0/20 • 90 days
Cardiac disorders Chest pain	4.8% 1/21 • Number of events 1 • 90 days	0.00% 0/21 • 90 days	0.00% 0/20 • 90 days
Skin and subcutaneous tissue disorders Pressure Sore	0.00% 0/21 • 90 days	0.00% 0/21 • 90 days	5.0% 1/20 • Number of events 1 • 90 days

Additional Information

Jeff Jasko

Philips

Phone: 4125423651

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place