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

NCT ID: NCT03748264

Last Updated: 2021-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-21
• Study Completion Date: 2014-05-27

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:

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.

Conditions

Sleep Disordered Breathing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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. Therapy information is available continuously to site staff personnel in the standard care arm.

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: OTHER

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

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

Group Type: EXPERIMENTAL

DreamMapper Application

Intervention Type: DEVICE

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

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

Group Type: EXPERIMENTAL

DreamMapper Application with Therapist Assist

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: 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.

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Philips Respironics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Wylie, MD

Role: PRINCIPAL_INVESTIGATOR

Arkansas Center For Sleep Medicine

Shalini Manchandra, MD

Role: PRINCIPAL_INVESTIGATOR

Program Director, Sleep Medicine Fellowship

Sukhdev Grover, MD

Role: PRINCIPAL_INVESTIGATOR

Sleep Center of Greater Pittsburgh

Eric Powell, PhD

Role: PRINCIPAL_INVESTIGATOR

Sleep Therapy & Research Center

Alan Lankford, MD

Role: PRINCIPAL_INVESTIGATOR

Sleep Disorders Center of Georgia, Inc.

Locations

Paul Wylie, MD

Little Rock, Arkansas, United States

Sleep Disorders Center of Georgia, Inc.

Atlanta, Georgia, United States

Shalini Manchanda, MD

Indianapolis, Indiana, United States

Sleep Center of Greater Pittsburgh

Pittsburgh, Pennsylvania, United States

Sleep Therapy & Research Center

San Antonio, Texas, United States

Countries

United States

Other Identifiers

ST-1203-APP-MS

Identifier Type: -

Identifier Source: org_study_id