N/A
N=169
CPAP (Continuous Positive Airway Pressure) Study Educational Materials and Usage Feedback to Promote CPAP Adherence
Adherence
Bottom Line
View on ClinicalTrials.gov: NCT02195531 ↗Enrolled (actual)
169
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcome: Primary: Nightly Adherence — 4.83; 5.82; 4.82; 4.60 hours
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Education and feedback (Behavioral)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Philips Respironics
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Nightly Adherence |
4.83; 5.82; 4.82; 4.60; 4.96; 4.19 | — |
| PRIMARY Adherence |
5.5; 5.8; 4.9 | — |
| SECONDARY Participant's Feedback on Educational Pamphlets - Expectations Scale |
4.42; 4.39; 4.33; 4.10; 4.01; 4.07 | — |
| SECONDARY Participant's Feedback on Educational Pamphlets - Importance Scale |
4.69; 4.58; 4.65; 4.53; 4.63; 4.62 | — |
| SECONDARY Participant's Feedback on Educational Pamphlets - Self-Efficacy Scale |
4.49; 4.20; 4.29; 4.26; 4.14; 4.07 | — |
| SECONDARY Participant's Feedback on Educational Pamphlets - Motiviation |
9.59; 9.32; 9.21; 9.10; 8.82; 8.85 | — |
| SECONDARY Participant's Feedback on Educational Pamphlets - Leaflet Assessment |
4.12; 4.04; 3.94; 3.95; 4.07; 3.99 | — |
Summary
The study hypothesis: in groups receiving tailored education and feedback in a style that matches their psychological profile, will show a higher CPAP adherence rates than groups receiving mismatched tailored education / feedback, and groups that receive no tailored education and feedback (standard of care).
Eligibility Criteria
Inclusion Criteria
- Males or females, ages 21-80 years
- Prescribed to start CPAP treatment and diagnosed with mild to severe OSA.
- Recently (within study period) diagnosed with Mild to Severe OSA defined as an Apnea-Hypopnea Index of equal to or greater than 10 events per hour of sleep.
- CPAP treatment naïve
Exclusion Criteria
- Inability to provide informed consent
- Presence of a comorbid condition that may potentially complicate CPAP adherence, such as:
- Unstable depressive disorder
- Unstable anxiety disorder
- Dementia
- Unable to understand study information
- Obesity Hypoventilation Syndrome
- Central Sleep Apnea or Complex Sleep Apnea
- Facial musculoskeletal disorder
- Unwillingness or inability to use CPAP therapy
- Unable to return for follow up appointment
- Use of supplemental oxygen
Data sourced from ClinicalTrials.gov (NCT02195531). 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.