Obstructive Sleep Apnea Treatment and Insulin Sensitivity in Pregnancy

BJC HealthCare

Status: Withdrawn

Conditions: Pregnancy Related; Insulin Sensitivity; Obstructive Sleep Apnea

Treatments: Device: Continuous Positive Airway Pressure

Study type: Interventional

Funder types: Other

Identifiers

NCT04013399

201905166

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 20 to 39 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

0 participants in 2 patient groups

Continuous Positive Airway Pressure

Experimental group

Description:

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

Treatment:

Device: Continuous Positive Airway Pressure

Control

No Intervention group

Description:

Women will receive standard prenatal care.