Obstructive Sleep Apnea Treatment and Insulin Sensitivity in Pregnancy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Obstructive Sleep Apnea Treatment and Insulin Sensitivity in Pregnancy

Conditions
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Obstructive Sleep Apnea, Pregnancy Related, Insulin Sensitivity

Intervention / Treatment
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* Device: Continuous Positive Airway Pressure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 28-32 weeks pregnant Age 20-39 BMI 30-40 kg/m2 pre-pregnancy (or first trimester) Obstructive Sleep Apnea (AHI≥15) Have a singleton pregnancy Exclusion Criteria: Diabetes (GDM, type 1 or type 2) Using beta blockers or glucocorticoids Have children who are ≤2 yrs old (risk of disrupted sleep) Diagnosed sleep disorders (other than sleep apnea) Night work schedule Diagnosed congestive heart failure Diagnosed lung disease (e.g. asthma, chronic obstructive pulmonary disease) Pre-gestational hypertension

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Continuous Positive Airway Pressure<br>Women will receive Continuous Positive Airway Pressure (CPAP) for one month. | Device: Continuous Positive Airway Pressure<br>* The device is an auto-adjusting pressure device with an integrated humidifier. Pressure is adjusted based on airway resistance.<br>|
| No Intervention: Control<br>Women will receive standard prenatal care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | Change in adipose tissue gene expression of inflammatory markers | 1 month |