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

Completed · Not applicable

Conditions studied: Sleep Disordered Breathing

In brief

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.

Key facts

Study ID

NCT03748264

Run by

Philips Respironics

People needed

62

Starts

2013-10-21

Expected to finish

2014-05-27

Last updated by the study team

2021-03-12

Who can join

Age: 21 and older, up to 75. Sex: any. Healthy volunteers: accepted.

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)

Where it is running

• 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

Full record on ClinicalTrials.gov

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