NCT03748264

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 21, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 27, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 27, 2014

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

November 13, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 20, 2018

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

March 12, 2021

Completed
Last Updated

March 12, 2021

Status Verified

March 1, 2021

Enrollment Period

7 months

First QC Date

November 13, 2018

Results QC Date

October 19, 2020

Last Update Submit

March 11, 2021

Conditions

Sleep Disordered Breathing

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Adherence

    90 days

  • Treatment Outcomes - Epworth Sleepiness Scale

    90 days

  • Treatment Outcomes - Functional Outcomes of Sleep Questionnaire (FOSQ)

    90 days

  • Site Economic Savings Assessed by Number of Phone Calls.

    90 days

  • Patient Interactions

    90 days

  • +2 more secondary outcomes

Study Arms (3)

Standard of Care

ACTIVE COMPARATOR

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

DreamMapper Application

EXPERIMENTAL

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

DreamMapper Application with Therapist Assist

EXPERIMENTAL

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

Interventions

Standard of CareOTHER

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.

Standard of Care
DreamMapper ApplicationDEVICE

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
DreamMapper Application with Therapist AssistDEVICE

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.

DreamMapper Application with Therapist Assist

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Paul Wylie, MD

Little Rock, Arkansas, 72211, United States

Location

Sleep Disorders Center of Georgia, Inc.

Atlanta, Georgia, 30342, United States

Location

Shalini Manchanda, MD

Indianapolis, Indiana, 46202, United States

Location

Sleep Center of Greater Pittsburgh

Pittsburgh, Pennsylvania, 15146, United States

Location

Sleep Therapy & Research Center

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Results Point of Contact

Title
Jeff Jasko
Organization
Philips
Jeff.Jasko@philips.com
4125423651

Study Officials

  • Paul Wylie, MD

    Arkansas Center For Sleep Medicine

    PRINCIPAL INVESTIGATOR

  • Shalini Manchandra, MD

    Program Director, Sleep Medicine Fellowship

    PRINCIPAL INVESTIGATOR

  • Sukhdev Grover, MD

    Sleep Center of Greater Pittsburgh

    PRINCIPAL INVESTIGATOR

  • Eric Powell, PhD

    Sleep Therapy & Research Center

    PRINCIPAL INVESTIGATOR

  • Alan Lankford, MD

    Sleep Disorders Center of Georgia, Inc.

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2018

First Posted

November 20, 2018

Study Start

October 21, 2013

Primary Completion

May 27, 2014

Study Completion

May 27, 2014

Last Updated

March 12, 2021

Results First Posted

March 12, 2021

Record last verified: 2021-03

Locations

US(5)