N/A
N=62
User Preference/Validation Evaluation of the New Philips Respironics Positive Airway Pressure Application
Sleep Disordered Breathing
Bottom Line
View on ClinicalTrials.gov: NCT03748264 ↗Enrolled (actual)
62
Serious AEs
1.6%
Results posted
Mar 2021
Primary outcome: Primary: User Preference of the New Philips Respironics Positive Airway Pressure Application as Measured by the Attitudes Toward Use Questionnaire — 7.5; 7.9; 8.8 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Standard of Care (Other); DreamMapper Application (Device); DreamMapper Application with Therapist Assist (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Philips Respironics
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY User Preference of the New Philips Respironics Positive Airway Pressure Application as Measured by the Attitudes Toward Use Questionnaire |
7.5; 7.9; 8.8 | — |
| SECONDARY Adherence |
4.6; 4.8; 4.0 | — |
| SECONDARY Treatment Outcomes - Epworth Sleepiness Scale |
6.4; 7.9; 7.7 | — |
| SECONDARY Treatment Outcomes - Functional Outcomes of Sleep Questionnaire (FOSQ) |
15.9; 16.0; 17.6 | — |
| SECONDARY Site Economic Savings Assessed by Number of Phone Calls. |
6; 7; 9 | — |
| SECONDARY Patient Interactions |
2; 3; 4 | — |
| SECONDARY Mask Refits |
2; 2; 3 | — |
| SECONDARY Overall Economic Cost Saving |
— | — |
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.
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)
Data sourced from ClinicalTrials.gov (NCT03748264). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.