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

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.

Conditions

• Sleep Disordered Breathing

Interventions

OTHER

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.

DEVICE

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.

DEVICE

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.

Sponsors & Collaborators

• Philips Respironics

  lead INDUSTRY

Principal Investigators

• Paul Wylie, MD · Arkansas Center For Sleep Medicine

• Shalini Manchandra, MD · Program Director, Sleep Medicine Fellowship

• Sukhdev Grover, MD · Sleep Center of Greater Pittsburgh

• Eric Powell, PhD · Sleep Therapy & Research Center

• Alan Lankford, MD · Sleep Disorders Center of Georgia, Inc.

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2013-10-21

Primary Completion

2014-05-27

Completion

2014-05-27

FDA Device

Yes

Countries

• United States

Study Locations