Automated Graduated CPAP (AGPAP) for Improved Adherence in Newly Diagnosed Obstructive Sleep Apnea (OSA) Patients

Philips

Status

Completed

Conditions

Obstructive Sleep Apnea

Treatments

Device: REMstar Auto A-Flex

Device: modified REMstar Auto A-Flex with AGPAP

Study type

Interventional

Funder types

Industry

Identifiers

NCT01450540

AR-1112-AGPAP-MS

Details and patient eligibility

About

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.

Full description

Even though CPAP is highly effective in treating sleep apnea, adherence to CPAP therapy remains the largest single obstacle to the successful resolution of sleep-disordered breathing in OSA patients. It has been estimated that up to 50% of patients who have been prescribed CPAP for Obstructive Sleep Apnea (OSA) are not using the treatment one year later. A myriad of possible causes for low compliance rates have been proposed and examined in previous studies. These include race, gender, education level, income, bed-partner's sleep quality, mask discomfort, continuity of care, nasal irritation, discomfort due to elevated expiratory pressure, and level of daytime sleepiness.

Therefore, many investigators have proposed new methods and approaches to help deal with these problems. Interventions have ranged from people-centric approaches using intensive CPAP education and follow-up programs, to device modifications using features such as a ramp, C-FLEX®, BiLevel therapy, and heated humidification.

In this study. The aim of this study was to determine the effectiveness of the Automated Graduated CPAP (AGPAP), also know as EZ-start acclimation period, and its impact on short term adherence

Enrollment

241 patients

Sex

All

Ages

25 to 70 years old

Volunteers

No Healthy Volunteers

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 < 70% for 10% of the diagnostic PSG study).
Surgery of the upper airway, nose, sinus, or middle ear within the past 90 days
Regular use (>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