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

Philips

Status: Completed

Conditions: Sleep Disordered Breathing

Treatments: Device: DreamMapper Application with Therapist Assist; Other: Standard of Care; Device: DreamMapper Application

Study type: Interventional

Funder types: Industry

Identifiers

NCT03748264

ST-1203-APP-MS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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62 participants in 3 patient groups

Standard of Care

Active Comparator group

Description:

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.

Treatment:

Other: Standard of Care

DreamMapper Application

Experimental group

Description:

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

Treatment:

Device: DreamMapper Application

DreamMapper Application with Therapist Assist

Experimental group

Description:

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

Treatment:

Device: DreamMapper Application with Therapist Assist