Obstructive Sleep Apnea Treatment and Insulin Sensitivity in Pregnancy

Not Applicable

Withdrawn

• Conditions: Insulin Sensitivity; Obstructive Sleep Apnea; Pregnancy Related
• Interventions: Device: Continuous Positive Airway Pressure

• Registration Number: NCT04013399
• Lead Sponsor: Barnes-Jewish Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-05-23
• Study First Submitted QC: 2019-07-08
• Study First Posted: 2019-07-09
• Study Start: 2020-07-01
• Primary Completion: 2022-09-30
• Study Completion: 2023-03-30
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-26
• Last Update Posted: 2023-07-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous Positive Airway Pressure	Continuous Positive Airway Pressure	Women will receive Continuous Positive Airway Pressure (CPAP) for one month.

Primary Outcome Measures

Name	Time	Method
Degree of Insulin Sensitivity measured by Matsuda Index by Oral glucose Tolerance Test	1 month	Change in whole body insulin sensitivity measured using Matsuda Index
Percent of Oxygen in blood by pulse oximetry	1 month	Change in oxygen saturation measured by pulse oximetry

Secondary Outcome Measures

Name	Time	Method
Percent of Oxygen in Adipose Tissue measured by oxygen tension probe	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	1 month	Change in adipose tissue gene expression of inflammatory markers

Trial Locations

Locations (1)

Washington University in St. Louis; 🇺🇸 Saint Louis, Missouri, United States