Obstructive Sleep Apnea Treatment and Insulin Sensitivity in Pregnancy
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|ClinicalTrials.gov Identifier: NCT04013399|
Recruitment Status : Withdrawn (Delayed due to Covid-19)
First Posted : July 9, 2019
Last Update Posted : July 27, 2023
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea Pregnancy Related Insulin Sensitivity||Device: Continuous Positive Airway Pressure||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Obstructive Sleep Apnea Treatment and Insulin Sensitivity in Pregnancy|
|Actual Study Start Date :||July 1, 2020|
|Estimated Primary Completion Date :||September 30, 2022|
|Estimated Study Completion Date :||March 30, 2023|
Experimental: Continuous Positive Airway Pressure
Women will receive Continuous Positive Airway Pressure (CPAP) for one month.
Device: Continuous Positive Airway Pressure
The device is an auto-adjusting pressure device with an integrated humidifier. Pressure is adjusted based on airway resistance.
No Intervention: Control
Women will receive standard prenatal care.
- Degree of Insulin Sensitivity measured by Matsuda Index by Oral glucose Tolerance Test [ Time Frame: 1 month ]Change in whole body insulin sensitivity measured using Matsuda Index
- Percent of Oxygen in blood by pulse oximetry [ Time Frame: 1 month ]Change in oxygen saturation measured by pulse oximetry
- Percent of Oxygen in Adipose Tissue measured by oxygen tension probe [ Time Frame: 1 month ]Change in adipose tissue oxygenation measured by oxygen tension
- Concentration of inflammatory gene expression in adipose Tissue measured by RNA and DNA sequencing [ Time Frame: 1 month ]Change in adipose tissue gene expression of inflammatory markers
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04013399
|United States, Missouri|
|Washington University in St. Louis|
|Saint Louis, Missouri, United States, 63127|