N/A
N=241
Automated Graduated CPAP (AGPAP) for Improved Adherence in Newly Diagnosed Obstructive Sleep Apnea (OSA) Patients
Obstructive Sleep Apnea
Bottom Line
View on ClinicalTrials.gov: NCT01450540 ↗Enrolled (actual)
241
Serious AEs
1.3%
Results posted
Mar 2021
Primary outcome: Primary: CPAP Adherence — 3.6; 4.0 hours per night
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- REMstar Auto A-Flex (Device); modified REMstar Auto A-Flex with AGPAP (Device)
- Age
- Adult, Older Adult · 25+ yrs
- Sex
- All
- Sponsor
- Philips Respironics
- Primary completion
- Apr 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY CPAP Adherence |
3.6; 4.0 | — |
| SECONDARY Functional Outcome Sleep Quality (FOSQ) |
3.35; 3.25 | — |
| SECONDARY Daytime Sleepiness as Measured by the Epworth Sleepiness Scale |
8.05; 8.27 | — |
Summary
Although positive airway pressure (PAP) is a highly effective treatment for sleep apnea, adherence to therapy remains an obstacle. Automated Graduated CPAP (AGPAP), also know as EZ-start, is an extended duration ramp, where the patient receives pressure below their prescription during an acclimation phase. The algorithm gradually increases pressure to therapy level based on usage. The aim of this study was to determine the effectiveness of the AGPAP acclimation period and its impact on short term adherence.
Eligibility Criteria
Inclusion Criteria
- Newly diagnosed with OSA (last 12 weeks)
- Prescribed continuous positive airway pressure (CPAP) pressure ≥ 10 cmH2O
- Willing and able to provide informed consent
- Able to follow instructions
Exclusion Criteria
- Participation in another interventional research study within the last 30 days
- Major controlled or an uncontrolled medical condition such as congestive heart failure, neuromuscular disease, renal failure, cancer, chronic obstructive pulmonary disease (COPD), respiratory failure or insufficiency, or patients requiring oxygen therapy (as determined by self-report and reviewed by the study PI.)
- Prior PAP prescription, use, or any prior OSA treatment, excluding split-night or titration PAP exposure.
- Prescribed BiLevel therapy
- Presence of untreated, non-OSA related sleep disorders (e.g. moderate to severe restless legs (PLMAI ≥ 20) or insomnia)
- History of an automobile accident or near accident in the last 12 months due to sleepiness.
- Severe oxygen desaturation on the PSG (Sa02 3 nights per week) of sleeping pills or stimulants.
- Currently working a night shift or rotating day/night shift.
- Unwillingness to try PAP at home.
- Presence of tracheostomy
Data sourced from ClinicalTrials.gov (NCT01450540). 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.