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

NCT ID: NCT01450540

Last Updated: 2021-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 241 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2013-04-30

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

Conditions

Obstructive Sleep Apnea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Group 1

REMStar auto A-Flex

Group Type: ACTIVE_COMPARATOR

REMstar Auto A-Flex

Intervention Type: DEVICE

Standard CPAP

Group 2

modified REMstar Auto A-Flex with AGPAP

Group Type: EXPERIMENTAL

modified REMstar Auto A-Flex with AGPAP

Intervention Type: DEVICE

Modified device -Software upgrade to GP 12

Interventions

REMstar Auto A-Flex

Standard CPAP

Intervention Type: DEVICE

modified REMstar Auto A-Flex with AGPAP

Modified device -Software upgrade to GP 12

Intervention Type: DEVICE

Other Intervention Names

Philips Respironics System One; Philips Respironics System One

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Philips Respironics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alan Lankford, PhD

Role: PRINCIPAL_INVESTIGATOR

Sleep Disorders Center of Georgia

Locations

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

Countries

United States

Other Identifiers

AR-1112-AGPAP-MS

Identifier Type: -

Identifier Source: org_study_id