Automated Graduated CPAP (AGPAP) for Improved Adherence in Newly Diagnosed Obstructive Sleep Apnea (OSA) Patients
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Group 1 REMStar auto A-Flex |
Device: REMstar Auto A-Flex
Standard CPAP
Other Names:
|
| 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:
|
Outcome Measures
Primary Outcome Measures
- CPAP Adherence [3 months]
Device usage (hours per night)
Secondary Outcome Measures
- Functional Outcome Sleep Quality (FOSQ) [3 months]
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 [3 months]
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'.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Delta Waves Sleep Disorder and Research Center | Colorado Springs | Colorado | United States | 80918 |
| 2 | Sleep Disorders Center of Georgia | Atlanta | Georgia | United States | 30342 |
| 3 | Clayton Sleep Institute | Saint Louis | Missouri | United States | 63143 |
| 4 | Clinilabs, Inc. | New York | New York | United States | 10019 |
| 5 | Sleep Therapy and Research Center | San Antonio | Texas | United States | 78229 |
Sponsors and Collaborators
- Philips Respironics
Investigators
- Principal Investigator: Alan Lankford, PhD, Sleep Disorders Center of Georgia
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AR-1112-AGPAP-MS
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Group 1 | Group 2 |
|---|---|---|
| Arm/Group Description | REMStar auto A-Flex REMstar Auto A-Flex: Standard CPAP | modified REMstar Auto A-Flex with AGPAP modified REMstar Auto A-Flex with AGPAP: Modified device -Software upgrade to GP 12 |
| Period Title: Overall Study | ||
| STARTED | 123 | 118 |
| COMPLETED | 101 | 82 |
| NOT COMPLETED | 22 | 36 |
Baseline Characteristics
| Arm/Group Title | Group 1 | Group 2 | Total |
|---|---|---|---|
| Arm/Group Description | REMStar auto A-Flex REMstar Auto A-Flex: Standard CPAP | modified REMstar Auto A-Flex with AGPAP modified REMstar Auto A-Flex with AGPAP: Modified device -Software upgrade to GP 12 | Total of all reporting groups |
| Overall Participants | 120 | 115 | 235 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
48.1
(10.5)
|
46.2
(11.0)
|
47.3
(10.8)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
49
40.8%
|
42
36.5%
|
91
38.7%
|
| Male |
71
59.2%
|
73
63.5%
|
144
61.3%
|
| Region of Enrollment (Count of Participants) | |||
| United States |
120
100%
|
115
100%
|
235
100%
|
| Apnea-hypopnea index (AHI) (events/hour) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [events/hour] |
44.6
(34.6)
|
42.2
(31.1)
|
43.4
(32.9)
|
| CPAP Prescription (cmH2O) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [cmH2O] |
12.1
(2.1)
|
12.3
(2.2)
|
12.2
(2.2)
|
| Functional Outcomes Sleep Questionnaire (FOSQ) (quality of life questionnaire (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
2.9
(0.6)
|
2.8
(0.7)
|
2.8
(0.6)
|
| Epworth Sleepiness Scale (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
12.2
(4.6)
|
11.6
(5.1)
|
11.9
(4.9)
|
Outcome Measures
| Title | CPAP Adherence |
|---|---|
| Description | Device usage (hours per night) |
| Time Frame | 3 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 241 participants were enrolled in the trial and randomized, group 1 = 123 and group 2 = 118. There were 3 protocol deviations in group 1 and 23 deviations in group 2. Data from these participants were excluded from the final analysis as per the statistical plan, and an intention to treat analysis was performed. |
| Arm/Group Title | Group 1 | Group 2 |
|---|---|---|
| Arm/Group Description | REMStar auto A-Flex REMstar Auto A-Flex: Standard CPAP | modified REMstar Auto A-Flex with AGPAP modified REMstar Auto A-Flex with AGPAP: Modified device -Software upgrade to GP 12 |
| Measure Participants | 120 | 95 |
| Mean (Standard Deviation) [hours per night] |
3.6
(2.5)
|
4.0
(2.3)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 241 participants were enrolled in the trial and randomized, group 1 = 123 and group 2 = 118. There were 3 protocol deviations in group 1 and 23 deviations in group 2. Data from these participants were excluded from the final analysis as per the statistical plan, and an intention to treat analysis was performed. |
| Arm/Group Title | Group 1- Standard CPAP | Group 2 -AGPAP |
|---|---|---|
| Arm/Group Description | REMStar auto A-Flex REMstar Auto A-Flex: Standard CPAP | modified REMstar Auto A-Flex with AGPAP modified REMstar Auto A-Flex with AGPAP: Modified device -Software upgrade to GP 12 |
| Measure Participants | 120 | 115 |
| Mean (Standard Deviation) [units on a scale] |
3.35
(0.68)
|
3.25
(0.64)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 241 participants were enrolled in the trial and randomized, group 1 = 123 and group 2 = 118. There were 3 protocol deviations in group 1 and 23 deviations in group 2. Data from these participants were excluded from the final analysis as per the statistical plan, and an intention to treat analysis was performed. |
| Arm/Group Title | Group 1- Standard CPAP | Group 2 -AGPAP |
|---|---|---|
| Arm/Group Description | REMStar auto A-Flex REMstar Auto A-Flex: Standard CPAP | modified REMstar Auto A-Flex with AGPAP modified REMstar Auto A-Flex with AGPAP: Modified device -Software upgrade to GP 12 |
| Measure Participants | 120 | 115 |
| Mean (Standard Deviation) [units on a scale] |
8.05
(4.45)
|
8.27
(4.8)
|
Adverse Events
| Time Frame | Adverse events were collected during the device trial period, e.g. 3 months | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Group 1- Standard CPAP | Group 2 -AGPAP | ||
| Arm/Group Description | REMStar auto A-Flex REMstar Auto A-Flex: Standard CPAP | modified REMstar Auto A-Flex with AGPAP modified REMstar Auto A-Flex with AGPAP: Modified device -Software upgrade to GP 12 | ||
All Cause Mortality |
||||
| Group 1- Standard CPAP | Group 2 -AGPAP | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/120 (0%) | 0/115 (0%) | ||
Serious Adverse Events |
||||
| Group 1- Standard CPAP | Group 2 -AGPAP | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/120 (1.7%) | 1/115 (0.9%) | ||
| Cardiac disorders | ||||
| Hypertension | 0/120 (0%) | 0 | 1/115 (0.9%) | 1 |
| Hospitalization | 1/120 (0.8%) | 1 | 0/115 (0%) | 0 |
| Product Issues | ||||
| Bipolar manic episode | 1/120 (0.8%) | 1 | 0/115 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| Group 1- Standard CPAP | Group 2 -AGPAP | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 30/120 (25%) | 33/115 (28.7%) | ||
| Cardiac disorders | ||||
| Congestive heart failure | 0/120 (0%) | 0 | 1/115 (0.9%) | 1 |
| Worsening of hypertension | 1/120 (0.8%) | 1 | 0/115 (0%) | 0 |
| Gastrointestinal disorders | ||||
| Aerophagia | 3/120 (2.5%) | 3 | 1/115 (0.9%) | 1 |
| Upset stomach and diarrhea | 1/120 (0.8%) | 1 | 3/115 (2.6%) | 4 |
| General disorders | ||||
| Dry mouth | 5/120 (4.2%) | 5 | 4/115 (3.5%) | 4 |
| cracked dental implant | 0/120 (0%) | 0 | 1/115 (0.9%) | 1 |
| Infections and infestations | ||||
| MRSA in armpit | 0/120 (0%) | 0 | 1/115 (0.9%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||
| Hand fracture | 1/120 (0.8%) | 1 | 0/115 (0%) | 0 |
| Ankle swelling | 1/120 (0.8%) | 1 | 0/115 (0%) | 0 |
| Musculoskeletal pain | 1/120 (0.8%) | 1 | 5/115 (4.3%) | 5 |
| Reproductive system and breast disorders | ||||
| Dry, Stuffy Nose or Nosebleeds, skin irritation | 11/120 (9.2%) | 11 | 4/115 (3.5%) | 4 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Cold/flu symptoms | 13/120 (10.8%) | 14 | 19/115 (16.5%) | 24 |
| Bronchites/asthma exacerbation | 1/120 (0.8%) | 2 | 1/115 (0.9%) | 1 |
| Upper respiratory tract infection | 3/120 (2.5%) | 4 | 4/115 (3.5%) | 4 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Senior Data Scientist |
|---|---|
| Organization | Philips |
| Phone | +14125423651 |
- AR-1112-AGPAP-MS