NCT04013399

Obstructive Sleep Apnea Treatment and Insulin Sensitivity in Pregnancy

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Barnes-Jewish Hospital · Academic / Other
• Sex: Female
• Age: 20 Years – 39 Years
• Healthy volunteers: Accepted

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.

Conditions

• Obstructive Sleep Apnea
• Pregnancy Related
• Insulin Sensitivity

Interventions

Type	Name	Description
DEVICE	Continuous Positive Airway Pressure	The device is an auto-adjusting pressure device with an integrated humidifier. Pressure is adjusted based on airway resistance.

Timeline

• Start date: 2020-07-01
• Primary completion: 2022-09-30
• Completion: 2023-03-30
• First posted: 2019-07-09
• Last updated: 2023-07-27

Locations

1 site across 1 country: United States