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

Completed · Not applicable

Conditions studied: Obstructive Sleep Apnea

In brief

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.

Key facts

Study ID

NCT01450540

Run by

Philips Respironics

People needed

241

Starts

2011-09-01

Expected to finish

2013-04-01

Last updated by the study team

2021-03-03

Who can join

Age: 25 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Delta Waves Sleep Disorder and Research Center — Colorado Springs, Colorado, United States
• Sleep Disorders Center of Georgia — Atlanta, Georgia, United States
• Clayton Sleep Institute — St Louis, Missouri, United States
• Clinilabs, Inc. — New York, New York, United States
• Sleep Therapy and Research Center — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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