Obstructive Sleep Apnea Treatment and Insulin Sensitivity in Pregnancy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2023-03-30

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.

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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.

Conditions

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Obstructive Sleep Apnea Pregnancy Related Insulin Sensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Continuous Positive Airway Pressure

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

Group Type EXPERIMENTAL

Continuous Positive Airway Pressure

Intervention Type DEVICE

The device is an auto-adjusting pressure device with an integrated humidifier. Pressure is adjusted based on airway resistance.

Control

Women will receive standard prenatal care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Continuous Positive Airway Pressure

The device is an auto-adjusting pressure device with an integrated humidifier. Pressure is adjusted based on airway resistance.

Intervention Type DEVICE

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes