Clinical trial NCT03748264: User Preference/Validation Evaluation of the New Philips Respironics Positive Airway Pressure Application
Official title: User Preference/Validation Evaluation of the New Philips Respironics Positive Airway Pressure Application
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disordered Breathing
Lead sponsor: Philips Respironics
Sponsor class: INDUSTRY
First posted: 2018-11-20
Enrollment: 62
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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)

Primary outcomes:
measure: User Preference of the New Philips Respironics Positive Airway Pressure Application as Measured by the Attitudes Toward Use Questionnaire
timeFrame: 90 days
Secondary outcomes:
measure: Adherence
timeFrame: 90 days
measure: Treatment Outcomes - Epworth Sleepiness Scale
timeFrame: 90 days
measure: Treatment Outcomes - Functional Outcomes of Sleep Questionnaire (FOSQ)
timeFrame: 90 days
measure: Site Economic Savings Assessed by Number of Phone Calls.
timeFrame: 90 days
measure: Patient Interactions
timeFrame: 90 days
measure: Mask Refits
timeFrame: 90 days
measure: Overall Economic Cost Saving
timeFrame: 90 days
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Paul Wylie, MD
state: Arkansas
city: Atlanta
country: United States
facility: Sleep Disorders Center of Georgia, Inc.
state: Georgia
city: Indianapolis
country: United States
facility: Shalini Manchanda, MD
state: Indiana
city: Pittsburgh
country: United States
facility: Sleep Center of Greater Pittsburgh
state: Pennsylvania
city: San Antonio
country: United States
facility: Sleep Therapy & Research Center
state: Texas
Study officials:
affiliation: Arkansas Center For Sleep Medicine
name: Paul Wylie, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Program Director, Sleep Medicine Fellowship
name: Shalini Manchandra, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sleep Center of Greater Pittsburgh
name: Sukhdev Grover, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sleep Therapy & Research Center
name: Eric Powell, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sleep Disorders Center of Georgia, Inc.
name: Alan Lankford, MD
role: PRINCIPAL_INVESTIGATOR
References: