Sleep Disordered Breathing, Obesity and Pregnancy Study (SOAP)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

242 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2022-02-28

Brief Summary

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The purpose of this study is to better understand how sleep apnea, a common sleep disorder in which a person has one or more pauses in breathing or shallow breaths while sleeping, may affect pregnancy and to determine the effect of Continuous Positive Airway Pressure (CPAP), a treatment that uses mild air pressure to keep the airways open during sleep, for pregnant women with sleep apnea.

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Detailed Description

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Emerging data support a link between sleep disordered breathing (SDB) and adverse pregnancy outcomes, particularly preeclampsia. Furthermore, SDB, which is characterized by intermittent nocturnal hypoxia-reoxygenation as well as sleep disruption, results in endothelial dysfunction and metabolic dysregulation, the same biological pathways that have been associated with adverse pregnancy outcomes. Obesity is a well-known risk factor for both adverse pregnancy outcomes and SDB, and has been associated with the same aforementioned biological aberrations. Therefore, obesity complicates the definition of a causal relationship between SDB and pregnancy outcomes. While some classic cardiovascular risk factors (prehypertension) are certainly relevant in pregnancy, there are also well-established risk factors that are unique to pregnancy (uterine vascular stiffness, placental angiogenic factors). The interplay between SDB, obesity and these unique cardiovascular risk factors remains undefined, and this proposal aims to address this knowledge gap. Without this data, our ability to understand how we can mitigate these risks through the use of therapeutic interventions for SDB, such as CPAP (continuous positive airway pressure), is compromised. To further address this knowledge gap, we will make use of the placenta's ability to accumulate evidence of damage over time and provide a record of maternal vascular health throughout gestation. Numerous placental lesions deriving from maternal vascular disease have been identified and can be readily detected on placental pathology. These lesions can provide a measure of the severity of hypoxic stress experienced by the fetus during gestation.

The investigators' central hypothesis is that SDB is an effect modifier that increases maternal cardiovascular risk and placental hypoxic injury in obese pregnant women, and that CPAP treatment during pregnancy will result in an improved cardiovascular risk and placental profile. To test this hypothesis the investigaotrs will identify a cohort of obese women both with and without SDB. The investigators will examine SDB's impact on maternal vascular stiffness (uterine artery Doppler), angiogenesis (pregnancy specific angiogenic factors e.g., sFLT-1) and metabolism (insulin resistance) across pregnancy (Aim 1). The investigators will perform a randomized controlled trial of autotitrating- CPAP verses sham-CPAP in pregnancy to examine the impact of CPAP treatment during pregnancy on cardiovascular risk (Aim 2) and will explore the interplay between SDB, CPAP and evidence of maternal vascular disease and chronic fetal hypoxia by evaluating the placental profile of obese women with and without SDB (Aim 3).

Conditions

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Obese Pregnancy Sleep Disordered Breathing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Obese, SDB negative

No intervention, observational comparison group

Group Type NO_INTERVENTION

No interventions assigned to this group

Obese, SDB postive, CPAP

Therapeutic CPAP

Group Type ACTIVE_COMPARATOR

CPAP

Intervention Type DEVICE

CPAP is a device that has a mask worn over the nose that is attached to a device that provides positive airway pressure. CPAP is worn while sleeping, it splints open the airway and prevents apneas (cessation of breathing) and hypopneas (reduced airflow while breathing).

Obese, SDB postive, sham-CPAP

Sham (non-therapeutic) CPAP

Group Type SHAM_COMPARATOR

sham-CPAP

Intervention Type DEVICE

Obese, SDB postive, sleep hygiene

Sleep hygiene information and local sleep resources

Group Type OTHER

Sleep hygiene

Intervention Type OTHER

Information about sleep apnea and healthy sleep. Information about local sleep resources

Interventions

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CPAP

CPAP is a device that has a mask worn over the nose that is attached to a device that provides positive airway pressure. CPAP is worn while sleeping, it splints open the airway and prevents apneas (cessation of breathing) and hypopneas (reduced airflow while breathing).

Intervention Type DEVICE

sham-CPAP

Intervention Type DEVICE

Sleep hygiene

Information about sleep apnea and healthy sleep. Information about local sleep resources

Intervention Type OTHER

Other Intervention Names

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Continuous Positive Airway Pressure

Eligibility Criteria

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Inclusion Criteria

* women between 14 0/7 and 20 6/7 weeks gestation at the time of their initial PSG assessment.
* Pregnancy and current BMI \>=30
* Self-reported frequent snoring (\>=3x/week over past month) or self-reported non-snorer.

Exclusion Criteria

* diagnosis of pregestational diabetes.
* self-report a history of sleep apena and who are using or were receommended by a physican to use a PAP device already
* twins

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No