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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL117167 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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This is a randomized control trial in people with diabetes and obstructive sleep apnea who will be randomly assigned for 3 months to PAP therapy along with healthy lifestyle and sleep education or healthy lifestyle and sleep education.
Research over the last decade has shown that obstructive sleep apnea (OSA) is a common condition in people with diabetes. Observational and experimental evidence also indicates that intermittent hypoxemia and recurrent arousals in OSA may alter glucose metabolism and worsen glycemic control. However, the impact of treating OSA with positive airway pressure (PAP) therapy on glycemic variability and control is not well defined. Adequately powered randomized clinical trials have yet to be performed to demonstrate whether PAP therapy for OSA in diabetics can improve glycemic variability (and control), decrease blood pressure, and reverse endothelial dysfunction. The overarching goal of this study is to determine whether PAP therapy for OSA in diabetics leads to improvements in (a) glycemic variability as assessed by self-monitoring of blood glucose and continuous monitoring of glucose; (b) glycosylated hemoglobin; (c) blood pressure; (d) endothelial function; (e) serum and urinary biomarkers; and (f) dyslipidemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| REMStar Positive Airway Pressure | Active Comparator | Positive pressure therapy is the standard of care for managing obstructive sleep apnea. |
|
| LifeStyle Counseling | Other | Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REMStar Positive Airway Pressure | Device | Positive airway pressure therapy is the standard of care for managing obstructive sleep apnea |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Continuous Glucose Monitoring System Standard Deviation | Continuous Glucose Monitoring Metrics - change in standard deviation between baseline and three months. | Baseline and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Difference in Systolic Blood Pressure | Mean difference between 3 months and baseline systolic blood pressures (in mmHg) by group. | Baseline and 3 months |
| Change in Endothelial Dysfunction as Assessed by the Reactive Hyperemic Index |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Naresh M Punjabi, MD, PhD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Bayview Medical Center | Baltimore | Maryland | 21224 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37062349 | Derived | Aurora RN, Rooney MR, Wang D, Selvin E, Punjabi NM. Effects of Positive Airway Pressure Therapy on Glycemic Variability in Patients With Type 2 Diabetes and OSA: A Randomized Controlled Trial. Chest. 2023 Oct;164(4):1057-1067. doi: 10.1016/j.chest.2023.04.017. Epub 2023 Apr 14. | |
| 36738249 | Derived | Fang M, Wang D, Rooney MR, Echouffo-Tcheugui JB, Coresh J, Aurora RN, Punjabi NM, Selvin E. Performance of the Glucose Management Indicator (GMI) in Type 2 Diabetes. Clin Chem. 2023 Apr 3;69(4):422-428. doi: 10.1093/clinchem/hvac210. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | REMStar Positive Airway Pressure | 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 |
| BG001 | LifeStyle Counseling |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Continuous Glucose Monitoring System Standard Deviation | Continuous Glucose Monitoring Metrics - change in standard deviation between baseline and three months. | Posted | Mean | Standard Deviation | mg/dL | Baseline and 3 months |
|
Three months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | REMStar Positive Airway Pressure | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stroke | Nervous system disorders | Systematic Assessment | Hospital admission for a right-sided stroke. Event reported to the Institutional Review Board and deemed not to be related to the research. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Naresh M. Punjabi | Johns Hopkins University | 410-550-6487 | npunjabi@jhmi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 30, 2017 | Mar 15, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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| LifeStyle Counseling | Behavioral | Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects. |
|
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.
| Baseline and 3 months |
| Heart Rate Variability | 3 months |
| Change in the Epworth Sleepiness Scale | 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 | Baseline and 3 months |
| Change in Post-Pre Meal Blood Glucose Levels | 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. | Baseline and 3 months |
| Change in Glycosylated Hemoglobin A1c Level | Change in point-of-care hemoglobin A1c (%) after three months. | Baseline and 3 months |
| Continuous Glucose Monitoring System Mean Amplitude Glucose Excursion | Mean Amplitude Glucose Excursion in mg/dL (difference between the peaks and troughs of glucose from continuous glucose monitoring at three months). | 3 months |
| Continuous Glucose Monitoring System Standard Deviation | The standard deviation of the glucose from continuous glucose monitoring at three months. | 3 months |
| Change in Continuous Glucose Monitoring System Mean Glucose | Continuous Glucose Monitoring Metric - change in average glucose level (mg/dL) from baseline to three months. | Baseline and 3 months |
| 36495162 | Derived | Selvin E, Wang D, Rooney MR, Fang M, Echouffo-Tcheugui JB, Zeger S, Sartini J, Tang O, Coresh J, Nisha Aurora R, Punjabi NM. Within-Person and Between-Sensor Variability in Continuous Glucose Monitoring Metrics. Clin Chem. 2023 Feb 1;69(2):180-188. doi: 10.1093/clinchem/hvac192. |
| 36108310 | Derived | Selvin E, Wang D, Rooney MR, Echouffo-Tcheugui J, Fang M, Zeger S, Sartini J, Tang O, Coresh J, Aurora RN, Punjabi NM. The Associations of Mean Glucose and Time in Range from Continuous Glucose Monitoring with HbA1c in Adults with Type 2 Diabetes. Diabetes Technol Ther. 2023 Jan;25(1):86-90. doi: 10.1089/dia.2022.0178. Epub 2022 Nov 23. |
| 33316455 | Derived | Rooney MR, Aurora RN, Wang D, Selvin E, Punjabi NM. Rationale and design of the Hyperglycemic Profiles in Obstructive Sleep Apnea (HYPNOS) trial. Contemp Clin Trials. 2021 Feb;101:106248. doi: 10.1016/j.cct.2020.106248. Epub 2020 Dec 11. |
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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| 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. |
|
|
| Secondary | Mean Difference in Systolic Blood Pressure | Mean difference between 3 months and baseline systolic blood pressures (in mmHg) by group. | Missing data is due to participants who did not have their blood pressure taken at three month timepoint. | Posted | Mean | Standard Error | mmHg | Baseline and 3 months |
|
|
|
| Secondary | Change in Endothelial Dysfunction as Assessed by the Reactive Hyperemic Index | 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. | Missing data is due to participants who did not complete the procedure at three months. | Posted | Mean | Standard Deviation | ratio | Baseline and 3 months |
|
|
|
| Secondary | Heart Rate Variability | No data was collected | Posted | 3 months |
|
|
| Secondary | Change in the Epworth Sleepiness Scale | 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 | Missing data points were due to participants not completing the survey at three months | Posted | Mean | Standard Deviation | units on a scale | Baseline and 3 months |
|
|
|
| Secondary | Change in Post-Pre Meal Blood Glucose Levels | 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. | One participant in the REMStar Positive Airway Pressure arm was missing data on the three month visit. | Posted | Mean | Standard Error | mg/dL | Baseline and 3 months |
|
|
|
| Secondary | Change in Glycosylated Hemoglobin A1c Level | Change in point-of-care hemoglobin A1c (%) after three months. | Posted | Mean | Standard Deviation | percentage of glycosylated hemoglobin | Baseline and 3 months |
|
|
|
| Secondary | Continuous Glucose Monitoring System Mean Amplitude Glucose Excursion | Mean Amplitude Glucose Excursion in mg/dL (difference between the peaks and troughs of glucose from continuous glucose monitoring at three months). | Posted | Mean | Standard Deviation | mg/dL | 3 months |
|
|
|
| Secondary | Continuous Glucose Monitoring System Standard Deviation | The standard deviation of the glucose from continuous glucose monitoring at three months. | Posted | Mean | Standard Deviation | mg/dL | 3 months |
|
|
|
| Secondary | Change in Continuous Glucose Monitoring System Mean Glucose | Continuous Glucose Monitoring Metric - change in average glucose level (mg/dL) from baseline to three months. | Posted | Mean | Standard Deviation | mg/dL | Baseline and 3 months |
|
|
|
| 0 |
| 92 |
| 1 |
| 92 |
| 0 |
| 92 |
| EG001 | 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. | 0 | 92 | 0 | 92 | 0 | 92 |
|
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| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| Change post-pre dinner |
|