Clinical trial NCT01450540: Automated Graduated CPAP (AGPAP) for Improved Adherence in Newly Diagnosed Obstructive Sleep Apnea (OSA) Patients
Official title: Automated Graduated CPAP (AGPAP) for Improved Adherence in Newly Diagnosed OSA Patients: Multicenter Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: Philips Respironics
Sponsor class: INDUSTRY
First posted: 2011-10-12
Enrollment: 241
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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

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 \< 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

Primary outcomes:
measure: CPAP Adherence
timeFrame: 3 months
Secondary outcomes:
measure: Functional Outcome Sleep Quality (FOSQ)
timeFrame: 3 months
measure: Daytime Sleepiness as Measured by the Epworth Sleepiness Scale
timeFrame: 3 months
Other outcomes:
Locations:
city: Colorado Springs
country: United States
facility: Delta Waves Sleep Disorder and Research Center
state: Colorado
city: Atlanta
country: United States
facility: Sleep Disorders Center of Georgia
state: Georgia
city: Saint Louis
country: United States
facility: Clayton Sleep Institute
state: Missouri
city: New York
country: United States
facility: Clinilabs, Inc.
state: New York
city: San Antonio
country: United States
facility: Sleep Therapy and Research Center
state: Texas
Study officials:
affiliation: Sleep Disorders Center of Georgia
name: Alan Lankford, PhD
role: PRINCIPAL_INVESTIGATOR
References: