Back to resultsAutomated Graduated CPAP (AGPAP) for Improved Adherence in Newly Diagnosed Obstructive Sleep Apnea (OSA) Patients
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
REMstar Auto A-Flex
modified REMstar Auto A-Flex with AGPAP
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea
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
Sites / Locations
- Delta Waves Sleep Disorder and Research Center
- Sleep Disorders Center of Georgia
- Clayton Sleep Institute
- Clinilabs, Inc.
- Sleep Therapy and Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Group 1
Group 2
Arm Description
REMStar auto A-Flex
modified REMstar Auto A-Flex with AGPAP
Outcomes
Primary Outcome Measures
CPAP Adherence
Device usage (hours per night)
Secondary Outcome Measures
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).
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'.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01450540
Brief Title
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
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
September 2011 (Actual)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Philips Respironics
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
241 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
REMStar auto A-Flex
Arm Title
Group 2
Arm Type
Experimental
Arm Description
modified REMstar Auto A-Flex with AGPAP
Intervention Type
Device
Intervention Name(s)
REMstar Auto A-Flex
Other Intervention Name(s)
Philips Respironics System One
Intervention Description
Standard CPAP
Intervention Type
Device
Intervention Name(s)
modified REMstar Auto A-Flex with AGPAP
Other Intervention Name(s)
Philips Respironics System One
Intervention Description
Modified device -Software upgrade to GP 12
Primary Outcome Measure Information:
Title
CPAP Adherence
Description
Device usage (hours per night)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Functional Outcome Sleep Quality (FOSQ)
Description
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).
Time Frame
3 months
Title
Daytime Sleepiness as Measured by the Epworth Sleepiness Scale
Description
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'.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan Lankford, PhD
Organizational Affiliation
Sleep Disorders Center of Georgia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Delta Waves Sleep Disorder and Research Center
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80918
Country
United States
Facility Name
Sleep Disorders Center of Georgia
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Clayton Sleep Institute
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63143
Country
United States
Facility Name
Clinilabs, Inc.
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
Sleep Therapy and Research Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Automated Graduated CPAP (AGPAP) for Improved Adherence in Newly Diagnosed Obstructive Sleep Apnea (OSA) Patients
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