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

Automated Graduated CPAP (AGPAP) for Improved Adherence in Newly Diagnosed OSA Patients: Multicenter Trial

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Device: REMstar Auto A-Flex; Device: modified REMstar Auto A-Flex with AGPAP

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

• Study Type: Interventional
• Enrollment (Actual): 241
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Colorado Springs, Colorado, United States, 80918
      • Delta Waves Sleep Disorder and Research Center
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Sleep Disorders Center of Georgia
  • Missouri
    • Saint Louis, Missouri, United States, 63143
      • Clayton Sleep Institute
  • New York
    • New York, New York, United States, 10019
      • Clinilabs, Inc.
  • Texas
    • San Antonio, Texas, United States, 78229
      • Sleep Therapy and Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Group 1; REMStar auto A-Flex	Device: REMstar Auto A-Flex; Standard CPAP; Other Names: Philips Respironics System One
EXPERIMENTAL: Group 2; modified REMstar Auto A-Flex with AGPAP	Device: modified REMstar Auto A-Flex with AGPAP; Modified device -Software upgrade to GP 12; Other Names: Philips Respironics System One

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CPAP Adherence	Device usage (hours per night)	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Outcome Sleep Quality (FOSQ)	Functional Outcomes Sleep Questionnaire (FOSQ) is a self-administered instrument designed to assess the impact of excessive sleepiness on daytime function and to quantify improvement after treatment. It contains 30 items divided into 5 subscales: Activity level, vigilance, intimacy and sexual relationships, general productivity, and social outcome. The patient rates the difficulty of performing a given activity on a 4-point scale (no difficulty to extreme difficulty) A mean score is calculated for each scale ranging from 0 (maximum functional impact) to 24 (no functional impact).	3 months
Daytime Sleepiness as Measured by the Epworth Sleepiness Scale	Epworth Sleepiness Scale (ESS) is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. The ESS score can range from 0 to 24. The higher the ESS score, the higher is the overall 'daytime sleepiness'.	3 months

Collaborators and Investigators

• Sponsor: Philips Respironics
• Investigators: Principal Investigator: Alan Lankford, PhD, Sleep Disorders Center of Georgia

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2011
• Primary Completion (ACTUAL): April 1, 2013
• Study Completion (ACTUAL): April 1, 2013

Study Registration Dates

• First Submitted: October 7, 2011
• First Submitted That Met QC Criteria: October 11, 2011
• First Posted (ESTIMATE): October 12, 2011

Study Record Updates

• Last Update Posted (ACTUAL): March 3, 2021
• Last Update Submitted That Met QC Criteria: February 10, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: AR-1112-AGPAP-MS