Trial Outcomes & Findings for Hyperglycemic Profiles in Obstructive Sleep Apnea: Effects of PAP Therapy (NCT NCT02454153)
NCT ID: NCT02454153
Last Updated: 2021-05-25
Results Overview
Continuous Glucose Monitoring Metrics - change in standard deviation between baseline and three months.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
184 participants
Primary outcome timeframe
Baseline and 3 months
Results posted on
2021-05-25
Participant Flow
Participant milestones
| Measure |
REMStar Positive Airway Pressure
Positive pressure therapy is the standard of care for managing obstructive sleep apnea. Participants also received Lifestyle counseling as described below.
REMStar Positive Airway Pressure: Positive airway pressure therapy is the standard of care for managing obstructive sleep apnea
Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects.
LifeStyle Counseling: Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects.
|
LifeStyle Counseling
Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects.
LifeStyle Counseling: Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects.
|
|---|---|---|
|
Overall Study
STARTED
|
92
|
92
|
|
Overall Study
COMPLETED
|
92
|
92
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Hyperglycemic Profiles in Obstructive Sleep Apnea: Effects of PAP Therapy
Baseline characteristics by cohort
| Measure |
REMStar Positive Airway Pressure
n=92 Participants
Positive pressure therapy is the standard of care for managing obstructive sleep apnea.
REMStar Positive Airway Pressure: Positive airway pressure therapy is the standard of care for managing obstructive sleep apnea
|
LifeStyle Counseling
n=92 Participants
Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects.
LifeStyle Counseling: Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects.
|
Total
n=184 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.4 years
STANDARD_DEVIATION 8.6 • n=99 Participants
|
60.8 years
STANDARD_DEVIATION 9.6 • n=107 Participants
|
59.6 years
STANDARD_DEVIATION 9.1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
90 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
94 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
29 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
63 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
53 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
103 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Body Mass Index (BMI)
|
33.8 kg/m^2
STANDARD_DEVIATION 5.5 • n=99 Participants
|
33.7 kg/m^2
STANDARD_DEVIATION 5.8 • n=107 Participants
|
33.8 kg/m^2
STANDARD_DEVIATION 5.6 • n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and 3 monthsContinuous Glucose Monitoring Metrics - change in standard deviation between baseline and three months.
Outcome measures
| Measure |
REMStar Positive Airway Pressure
n=92 Participants
Positive pressure therapy is the standard of care for managing obstructive sleep apnea. Participants also received Lifestyle counseling as described below.
REMStar Positive Airway Pressure: Positive airway pressure therapy is the standard of care for managing obstructive sleep apnea
Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects.
LifeStyle Counseling: Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects.
|
LifeStyle Counseling
n=92 Participants
Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects.
LifeStyle Counseling: Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects.
|
|---|---|---|
|
Change in Continuous Glucose Monitoring System Standard Deviation
|
0.8 mg/dL
Standard Deviation 6.7
|
1.1 mg/dL
Standard Deviation 8.6
|
SECONDARY outcome
Timeframe: Baseline and 3 monthsPopulation: Missing data is due to participants who did not have their blood pressure taken at three month timepoint.
Mean difference between 3 months and baseline systolic blood pressures (in mmHg) by group.
Outcome measures
| Measure |
REMStar Positive Airway Pressure
n=87 Participants
Positive pressure therapy is the standard of care for managing obstructive sleep apnea. Participants also received Lifestyle counseling as described below.
REMStar Positive Airway Pressure: Positive airway pressure therapy is the standard of care for managing obstructive sleep apnea
Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects.
LifeStyle Counseling: Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects.
|
LifeStyle Counseling
n=88 Participants
Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects.
LifeStyle Counseling: Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects.
|
|---|---|---|
|
Mean Difference in Systolic Blood Pressure
|
-7.3 mmHg
Standard Error 6.1
|
7.4 mmHg
Standard Error 5.8
|
SECONDARY outcome
Timeframe: Baseline and 3 monthsPopulation: Missing data is due to participants who did not complete the procedure at three months.
Endothelial function was measured by the EndoPAT device - difference at 3 months - baseline, by group. The outcome reported is the Reactive Hyperemic Index (RHI). The RHI is a measure of endothelial vasodilator function. The RHI is the post-to-pre occlusion peripheral arterial tone signal ratio in the occluded arm relative to the other arm, which is not occluded. Persons with worse endothelial function have a lower RHI score. Consequently, a low RHI indicates more endothelial dysfunction. A value of 1.67 or less is considered abnormal vascular tone. The reported lower and upper limits in adults with type 2 diabetes is 1.1 - 4.9.
Outcome measures
| Measure |
REMStar Positive Airway Pressure
n=86 Participants
Positive pressure therapy is the standard of care for managing obstructive sleep apnea. Participants also received Lifestyle counseling as described below.
REMStar Positive Airway Pressure: Positive airway pressure therapy is the standard of care for managing obstructive sleep apnea
Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects.
LifeStyle Counseling: Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects.
|
LifeStyle Counseling
n=85 Participants
Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects.
LifeStyle Counseling: Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects.
|
|---|---|---|
|
Change in Endothelial Dysfunction as Assessed by the Reactive Hyperemic Index
|
-0.0014 ratio
Standard Deviation 0.65
|
0.0024 ratio
Standard Deviation 0.69
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: No data was collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 3 monthsPopulation: Missing data points were due to participants not completing the survey at three months
The Epworth Sleepiness Scale measures self-reported sleep propensity or daytime sleepiness. The range of the scale is 0 to 24 (integers only), with increasing values corresponding to increasing sleepiness. A cut-point of ≥ 11 is also sometimes used to differentiate those with pathological sleepiness (≥ 11) versus those without \< 11. The difference between the three month final visit - the baseline visit score is reported by group
Outcome measures
| Measure |
REMStar Positive Airway Pressure
n=83 Participants
Positive pressure therapy is the standard of care for managing obstructive sleep apnea. Participants also received Lifestyle counseling as described below.
REMStar Positive Airway Pressure: Positive airway pressure therapy is the standard of care for managing obstructive sleep apnea
Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects.
LifeStyle Counseling: Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects.
|
LifeStyle Counseling
n=83 Participants
Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects.
LifeStyle Counseling: Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects.
|
|---|---|---|
|
Change in the Epworth Sleepiness Scale
|
-2.5 units on a scale
Standard Deviation 4.3
|
-1.3 units on a scale
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: Baseline and 3 monthsPopulation: One participant in the REMStar Positive Airway Pressure arm was missing data on the three month visit.
The difference from baseline to three months in self-reported in blood glucose levels before and after meals (mg/dL) (post-meal - pre-meal). Data is presented for breakfast, lunch, and dinner.
Outcome measures
| Measure |
REMStar Positive Airway Pressure
n=91 Participants
Positive pressure therapy is the standard of care for managing obstructive sleep apnea. Participants also received Lifestyle counseling as described below.
REMStar Positive Airway Pressure: Positive airway pressure therapy is the standard of care for managing obstructive sleep apnea
Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects.
LifeStyle Counseling: Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects.
|
LifeStyle Counseling
n=92 Participants
Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects.
LifeStyle Counseling: Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects.
|
|---|---|---|
|
Change in Post-Pre Meal Blood Glucose Levels
Change post-pre breakfast
|
-9.9 mg/dL
Standard Error 4.8
|
-1.3 mg/dL
Standard Error 4.8
|
|
Change in Post-Pre Meal Blood Glucose Levels
Change post-pre lunch
|
1.0 mg/dL
Standard Error 5.4
|
-6.1 mg/dL
Standard Error 5.4
|
|
Change in Post-Pre Meal Blood Glucose Levels
Change post-pre dinner
|
-3.0 mg/dL
Standard Error 5.1
|
3.7 mg/dL
Standard Error 5.1
|
SECONDARY outcome
Timeframe: Baseline and 3 monthsChange in point-of-care hemoglobin A1c (%) after three months.
Outcome measures
| Measure |
REMStar Positive Airway Pressure
n=92 Participants
Positive pressure therapy is the standard of care for managing obstructive sleep apnea. Participants also received Lifestyle counseling as described below.
REMStar Positive Airway Pressure: Positive airway pressure therapy is the standard of care for managing obstructive sleep apnea
Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects.
LifeStyle Counseling: Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects.
|
LifeStyle Counseling
n=92 Participants
Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects.
LifeStyle Counseling: Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects.
|
|---|---|---|
|
Change in Glycosylated Hemoglobin A1c Level
|
0.2 percentage of glycosylated hemoglobin
Standard Deviation 0.7
|
0.2 percentage of glycosylated hemoglobin
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: 3 monthsMean Amplitude Glucose Excursion in mg/dL (difference between the peaks and troughs of glucose from continuous glucose monitoring at three months).
Outcome measures
| Measure |
REMStar Positive Airway Pressure
n=92 Participants
Positive pressure therapy is the standard of care for managing obstructive sleep apnea. Participants also received Lifestyle counseling as described below.
REMStar Positive Airway Pressure: Positive airway pressure therapy is the standard of care for managing obstructive sleep apnea
Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects.
LifeStyle Counseling: Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects.
|
LifeStyle Counseling
n=92 Participants
Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects.
LifeStyle Counseling: Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects.
|
|---|---|---|
|
Continuous Glucose Monitoring System Mean Amplitude Glucose Excursion
|
69.5 mg/dL
Standard Deviation 20.5
|
71.4 mg/dL
Standard Deviation 20.4
|
SECONDARY outcome
Timeframe: 3 monthsThe standard deviation of the glucose from continuous glucose monitoring at three months.
Outcome measures
| Measure |
REMStar Positive Airway Pressure
n=92 Participants
Positive pressure therapy is the standard of care for managing obstructive sleep apnea. Participants also received Lifestyle counseling as described below.
REMStar Positive Airway Pressure: Positive airway pressure therapy is the standard of care for managing obstructive sleep apnea
Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects.
LifeStyle Counseling: Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects.
|
LifeStyle Counseling
n=92 Participants
Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects.
LifeStyle Counseling: Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects.
|
|---|---|---|
|
Continuous Glucose Monitoring System Standard Deviation
|
38.7 mg/dL
Standard Deviation 11.3
|
39.2 mg/dL
Standard Deviation 10.8
|
SECONDARY outcome
Timeframe: Baseline and 3 monthsContinuous Glucose Monitoring Metric - change in average glucose level (mg/dL) from baseline to three months.
Outcome measures
| Measure |
REMStar Positive Airway Pressure
n=92 Participants
Positive pressure therapy is the standard of care for managing obstructive sleep apnea. Participants also received Lifestyle counseling as described below.
REMStar Positive Airway Pressure: Positive airway pressure therapy is the standard of care for managing obstructive sleep apnea
Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects.
LifeStyle Counseling: Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects.
|
LifeStyle Counseling
n=92 Participants
Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects.
LifeStyle Counseling: Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects.
|
|---|---|---|
|
Change in Continuous Glucose Monitoring System Mean Glucose
|
4.3 mg/dL
Standard Deviation 25.3
|
9.5 mg/dL
Standard Deviation 29.3
|
Adverse Events
REMStar Positive Airway Pressure
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
LifeStyle Counseling
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
REMStar Positive Airway Pressure
n=92 participants at risk
Positive pressure therapy is the standard of care for managing obstructive sleep apnea.
REMStar Positive Airway Pressure: Positive airway pressure therapy is the standard of care for managing obstructive sleep apnea
|
LifeStyle Counseling
n=92 participants at risk
Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects.
LifeStyle Counseling: Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects.
|
|---|---|---|
|
Nervous system disorders
Stroke
|
1.1%
1/92 • Number of events 1 • Three months
|
0.00%
0/92 • Three months
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place