Trial Outcomes & Findings for Automated Graduated CPAP (AGPAP) for Improved Adherence in Newly Diagnosed Obstructive Sleep Apnea (OSA) Patients (NCT NCT01450540)
NCT ID: NCT01450540
Last Updated: 2021-03-03
Results Overview
Device usage (hours per night)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
241 participants
Primary outcome timeframe
3 months
Results posted on
2021-03-03
Participant Flow
Participant milestones
| Measure |
Group 1
REMStar auto A-Flex
REMstar Auto A-Flex: Standard CPAP
|
Group 2
modified REMstar Auto A-Flex with AGPAP
modified REMstar Auto A-Flex with AGPAP: Modified device -Software upgrade to GP 12
|
|---|---|---|
|
Overall Study
STARTED
|
123
|
118
|
|
Overall Study
COMPLETED
|
101
|
82
|
|
Overall Study
NOT COMPLETED
|
22
|
36
|
Reasons for withdrawal
| Measure |
Group 1
REMStar auto A-Flex
REMstar Auto A-Flex: Standard CPAP
|
Group 2
modified REMstar Auto A-Flex with AGPAP
modified REMstar Auto A-Flex with AGPAP: Modified device -Software upgrade to GP 12
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
19
|
13
|
|
Overall Study
protocol deviation
|
3
|
23
|
Baseline Characteristics
Automated Graduated CPAP (AGPAP) for Improved Adherence in Newly Diagnosed Obstructive Sleep Apnea (OSA) Patients
Baseline characteristics by cohort
| Measure |
Group 1
n=120 Participants
REMStar auto A-Flex
REMstar Auto A-Flex: Standard CPAP
|
Group 2
n=115 Participants
modified REMstar Auto A-Flex with AGPAP
modified REMstar Auto A-Flex with AGPAP: Modified device -Software upgrade to GP 12
|
Total
n=235 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.1 years
STANDARD_DEVIATION 10.5 • n=93 Participants
|
46.2 years
STANDARD_DEVIATION 11.0 • n=4 Participants
|
47.3 years
STANDARD_DEVIATION 10.8 • n=27 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=93 Participants
|
42 Participants
n=4 Participants
|
91 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
71 Participants
n=93 Participants
|
73 Participants
n=4 Participants
|
144 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
120 Participants
n=93 Participants
|
115 Participants
n=4 Participants
|
235 Participants
n=27 Participants
|
|
Apnea-hypopnea index (AHI)
|
44.6 events/hour
STANDARD_DEVIATION 34.6 • n=93 Participants
|
42.2 events/hour
STANDARD_DEVIATION 31.1 • n=4 Participants
|
43.4 events/hour
STANDARD_DEVIATION 32.9 • n=27 Participants
|
|
CPAP Prescription
|
12.1 cmH2O
STANDARD_DEVIATION 2.1 • n=93 Participants
|
12.3 cmH2O
STANDARD_DEVIATION 2.2 • n=4 Participants
|
12.2 cmH2O
STANDARD_DEVIATION 2.2 • n=27 Participants
|
|
Functional Outcomes Sleep Questionnaire (FOSQ) (quality of life questionnaire
|
2.9 units on a scale
STANDARD_DEVIATION 0.6 • n=93 Participants
|
2.8 units on a scale
STANDARD_DEVIATION 0.7 • n=4 Participants
|
2.8 units on a scale
STANDARD_DEVIATION 0.6 • n=27 Participants
|
|
Epworth Sleepiness Scale
|
12.2 units on a scale
STANDARD_DEVIATION 4.6 • n=93 Participants
|
11.6 units on a scale
STANDARD_DEVIATION 5.1 • n=4 Participants
|
11.9 units on a scale
STANDARD_DEVIATION 4.9 • n=27 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: 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.
Device usage (hours per night)
Outcome measures
| Measure |
Group 1
n=120 Participants
REMStar auto A-Flex
REMstar Auto A-Flex: Standard CPAP
|
Group 2
n=95 Participants
modified REMstar Auto A-Flex with AGPAP
modified REMstar Auto A-Flex with AGPAP: Modified device -Software upgrade to GP 12
|
|---|---|---|
|
CPAP Adherence
|
3.6 hours per night
Standard Deviation 2.5
|
4.0 hours per night
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: 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.
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).
Outcome measures
| Measure |
Group 1
n=120 Participants
REMStar auto A-Flex
REMstar Auto A-Flex: Standard CPAP
|
Group 2
n=115 Participants
modified REMstar Auto A-Flex with AGPAP
modified REMstar Auto A-Flex with AGPAP: Modified device -Software upgrade to GP 12
|
|---|---|---|
|
Functional Outcome Sleep Quality (FOSQ)
|
3.35 units on a scale
Standard Deviation 0.68
|
3.25 units on a scale
Standard Deviation 0.64
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: 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.
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'.
Outcome measures
| Measure |
Group 1
n=120 Participants
REMStar auto A-Flex
REMstar Auto A-Flex: Standard CPAP
|
Group 2
n=115 Participants
modified REMstar Auto A-Flex with AGPAP
modified REMstar Auto A-Flex with AGPAP: Modified device -Software upgrade to GP 12
|
|---|---|---|
|
Daytime Sleepiness as Measured by the Epworth Sleepiness Scale
|
8.05 units on a scale
Standard Deviation 4.45
|
8.27 units on a scale
Standard Deviation 4.8
|
Adverse Events
Group 1- Standard CPAP
Serious events: 2 serious events
Other events: 30 other events
Deaths: 0 deaths
Group 2 -AGPAP
Serious events: 1 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1- Standard CPAP
n=120 participants at risk
REMStar auto A-Flex
REMstar Auto A-Flex: Standard CPAP
|
Group 2 -AGPAP
n=115 participants at risk
modified REMstar Auto A-Flex with AGPAP
modified REMstar Auto A-Flex with AGPAP: Modified device -Software upgrade to GP 12
|
|---|---|---|
|
Cardiac disorders
Hypertension
|
0.00%
0/120 • Adverse events were collected during the device trial period, e.g. 3 months
|
0.87%
1/115 • Number of events 1 • Adverse events were collected during the device trial period, e.g. 3 months
|
|
Cardiac disorders
Hospitalization
|
0.83%
1/120 • Number of events 1 • Adverse events were collected during the device trial period, e.g. 3 months
|
0.00%
0/115 • Adverse events were collected during the device trial period, e.g. 3 months
|
|
Product Issues
Bipolar manic episode
|
0.83%
1/120 • Number of events 1 • Adverse events were collected during the device trial period, e.g. 3 months
|
0.00%
0/115 • Adverse events were collected during the device trial period, e.g. 3 months
|
Other adverse events
| Measure |
Group 1- Standard CPAP
n=120 participants at risk
REMStar auto A-Flex
REMstar Auto A-Flex: Standard CPAP
|
Group 2 -AGPAP
n=115 participants at risk
modified REMstar Auto A-Flex with AGPAP
modified REMstar Auto A-Flex with AGPAP: Modified device -Software upgrade to GP 12
|
|---|---|---|
|
General disorders
Dry mouth
|
4.2%
5/120 • Number of events 5 • Adverse events were collected during the device trial period, e.g. 3 months
|
3.5%
4/115 • Number of events 4 • Adverse events were collected during the device trial period, e.g. 3 months
|
|
Gastrointestinal disorders
Aerophagia
|
2.5%
3/120 • Number of events 3 • Adverse events were collected during the device trial period, e.g. 3 months
|
0.87%
1/115 • Number of events 1 • Adverse events were collected during the device trial period, e.g. 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Cold/flu symptoms
|
10.8%
13/120 • Number of events 14 • Adverse events were collected during the device trial period, e.g. 3 months
|
16.5%
19/115 • Number of events 24 • Adverse events were collected during the device trial period, e.g. 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchites/asthma exacerbation
|
0.83%
1/120 • Number of events 2 • Adverse events were collected during the device trial period, e.g. 3 months
|
0.87%
1/115 • Number of events 1 • Adverse events were collected during the device trial period, e.g. 3 months
|
|
Musculoskeletal and connective tissue disorders
Hand fracture
|
0.83%
1/120 • Number of events 1 • Adverse events were collected during the device trial period, e.g. 3 months
|
0.00%
0/115 • Adverse events were collected during the device trial period, e.g. 3 months
|
|
Cardiac disorders
Congestive heart failure
|
0.00%
0/120 • Adverse events were collected during the device trial period, e.g. 3 months
|
0.87%
1/115 • Number of events 1 • Adverse events were collected during the device trial period, e.g. 3 months
|
|
Musculoskeletal and connective tissue disorders
Ankle swelling
|
0.83%
1/120 • Number of events 1 • Adverse events were collected during the device trial period, e.g. 3 months
|
0.00%
0/115 • Adverse events were collected during the device trial period, e.g. 3 months
|
|
Gastrointestinal disorders
Upset stomach and diarrhea
|
0.83%
1/120 • Number of events 1 • Adverse events were collected during the device trial period, e.g. 3 months
|
2.6%
3/115 • Number of events 4 • Adverse events were collected during the device trial period, e.g. 3 months
|
|
General disorders
cracked dental implant
|
0.00%
0/120 • Adverse events were collected during the device trial period, e.g. 3 months
|
0.87%
1/115 • Number of events 1 • Adverse events were collected during the device trial period, e.g. 3 months
|
|
Reproductive system and breast disorders
Dry, Stuffy Nose or Nosebleeds, skin irritation
|
9.2%
11/120 • Number of events 11 • Adverse events were collected during the device trial period, e.g. 3 months
|
3.5%
4/115 • Number of events 4 • Adverse events were collected during the device trial period, e.g. 3 months
|
|
Cardiac disorders
Worsening of hypertension
|
0.83%
1/120 • Number of events 1 • Adverse events were collected during the device trial period, e.g. 3 months
|
0.00%
0/115 • Adverse events were collected during the device trial period, e.g. 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
2.5%
3/120 • Number of events 4 • Adverse events were collected during the device trial period, e.g. 3 months
|
3.5%
4/115 • Number of events 4 • Adverse events were collected during the device trial period, e.g. 3 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.83%
1/120 • Number of events 1 • Adverse events were collected during the device trial period, e.g. 3 months
|
4.3%
5/115 • Number of events 5 • Adverse events were collected during the device trial period, e.g. 3 months
|
|
Infections and infestations
MRSA in armpit
|
0.00%
0/120 • Adverse events were collected during the device trial period, e.g. 3 months
|
0.87%
1/115 • Number of events 1 • Adverse events were collected during the device trial period, e.g. 3 months
|
Additional Information
Senior Data Scientist
Philips
Phone: +14125423651
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place