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Delayed due to Covid-19
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| Name | Class |
|---|---|
| Washington University School of Medicine | OTHER |
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This study will evaluate the effect of treatment of obstructive sleep apnea on insulin sensitivity in pregnant women. Women in their third trimester of pregnancy will be randomized to receive treatment or no treatment for one month.
Obstructive Sleep Apnea (OSA) worsens over pregnancy and is related to increased risk of gestational diabetes. Despite the fact that sleep disturbances are common during pregnancy, OSA remains under-diagnosed, and poorly understood particularly in pregnancies affected by obesity. At least 25 percent of pregnancies are now affected by obesity, a leading risk factor for OSA, yet the effect of treatment of OSA on patterns of metabolic function and specifically decreased insulin sensitivity in pregnant women with obesity is a neglected area with major therapeutic implications to improve maternal health. Inflammation with OSA may decrease insulin sensitivity. Continuous positive airway pressure (CPAP) is a known effective treatment for OSA and has been shown to improve insulin sensitivity outside of pregnancy. Our overall hypothesis is that, compared with standard care, CPAP will improve nighttime breathing, blood and tissue oxygenation, decrease markers of inflammation, and increase insulin sensitivity. Using a randomized controlled trial, we will determine the effect of CPAP on metabolic dysfunction induced by OSA in pregnant women with obesity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous Positive Airway Pressure | Experimental | Women will receive Continuous Positive Airway Pressure (CPAP) for one month. |
|
| Control | No Intervention | Women will receive standard prenatal care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Positive Airway Pressure | Device | The device is an auto-adjusting pressure device with an integrated humidifier. Pressure is adjusted based on airway resistance. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Degree of Insulin Sensitivity measured by Matsuda Index by Oral glucose Tolerance Test | Change in whole body insulin sensitivity measured using Matsuda Index | 1 month |
| Percent of Oxygen in blood by pulse oximetry | Change in oxygen saturation measured by pulse oximetry | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Oxygen in Adipose Tissue measured by oxygen tension probe | Change in adipose tissue oxygenation measured by oxygen tension | 1 month |
| Concentration of inflammatory gene expression in adipose Tissue measured by RNA and DNA sequencing |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University in St. Louis | St Louis | Missouri | 63127 | United States |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
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Change in adipose tissue gene expression of inflammatory markers
| 1 month |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D012138 |
| Respiratory Therapy |