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

Sleep Disordered Breathing Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03748264
• Other study ID #: ST-1203-APP-MS
• Status: Completed
• Phase: N/A
• Start date: October 21, 2013
• Est. completion date: May 27, 2014

Study information

• Verified date: March 2021
• Source: Philips Respironics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: May 27, 2014
• Est. primary completion date: May 27, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Sleep Apnea Syndromes
• Sleep Disordered Breathing

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Sleep Disorders Center of Georgia, Inc.	Atlanta	Georgia
United States	Shalini Manchanda, MD	Indianapolis	Indiana
United States	Paul Wylie, MD	Little Rock	Arkansas
United States	Sleep Center of Greater Pittsburgh	Pittsburgh	Pennsylvania
United States	Sleep Therapy & Research Center	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Philips Respironics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Adherence	Adherence will be measured among the three groups to determine which participants used their Positive Airway Pressure device most throughout the trial: DreamMapper compared to site standard of care compared to using DreamMapper and Therapist Assist.	90 days
Secondary	Treatment Outcomes - Epworth Sleepiness Scale	Treatment outcomes will be assess by the Epworth Sleepiness Scale. The Epworth Sleepiness is 8 question survey asking questions about likelihood to fall asleep, each questions is answered on a 0 to 3 scale, 0-no chance, 3-high chance, the higher the score the higher likelihood of daytime sleepiness. The scale is 0-24, 0-no chance to fall asleep.	90 days
Secondary	Treatment Outcomes - Functional Outcomes of Sleep Questionnaire (FOSQ)	Treatment outcomes will be assess by the Functional Outcomes of Sleep Questionnaire. The FOSQ is a specific quality of life questionnaire to determine functional status in adults; measures are designed to assess the impact of disorders of excessive sleepiness on multiple activities of everyday living and the extent to which these abilities are improved by effective treatment. It asks sets of questions for activity level, vigilance, intimacy and sexual relationships, general productivity, social outcome, rate the difficulty of performing a given activity on a 4-point scale (4-no difficulty to 1-extreme difficulty 0-I do not do it for other reasons). 10 questions are asked with the lowest score of 0 and the highest of score of 40. The lower the score the more difficulty it is to complete tasks.	90 days
Secondary	Site Economic Savings Assessed by Number of Phone Calls.	Site economics savings will be collected and analyzed by reviewing the number of phone calls per arm. Exact numeric amounts of savings are not available but number of calls is.	90 days
Secondary	Patient Interactions	Site and patient interactions will be assessed after 90 days by reviewing the exact number of unscheduled visits in each arm.	90 days
Secondary	Mask Refits	Number of patient visits requiring mask refits will be measured and recorded. The exact number of mask refits will be provided.	90 days
Secondary	Overall Economic Cost Saving	Analysis will be done on the overall economic cost savings from Therapist Assist and DreamMapper	90 days