Prevalence Study of Sleep Apnea in Women With Preeclampsia

Study Overview
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Brief Summary
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Hypothesis: The prevalence of sleep apnea is greater in pregnant women with preeclampsia than in pregnant women without preeclampsia.The presence of sleep apnea will be associated with poor blood pressure control, worsening blood pressure during sleep and evidence of fetal distress. The usual treatment for sleep apnea is to have the patient breathe pressurized air through a mask. This is called continuous positive airway pressure (CPAP). In preeclamptic women with sleep apnea, use of CPAP will result in improved blood pressure control and reduced fetal distress.

Detailed Description
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Sleep apnea is common in the adult population. In middle aged men, the presence of sleep apnea has been correlated with hypertension, cardiovascular disease and mood disorders. Sleep apnea is not as well studied in women and even less is known about sleep apnea in pregnant women. However, preliminary evidence suggests that the incidence is quite high, particularly in women with severe preeclampsia. We propose to perform sleep studies on 30 women with preeclampsia and 30 healthy pregnant controls. In addition to the usual sleep study monitoring, we will also measure beat-to-beat blood pressure through non-invasive monitoring and we will do continuous electronic fetal monitoring. Women found to have sleep apnea will have a repeat study in which CPAP therapy is applied, and be provided CPAP therapy for nightly use at home.

Official Title
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Sleep Disordered Breathing and Preeclampsia

Conditions
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Preeclampsia

Intervention / Treatment
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* Device: CPAP therapy for subjects diagnosed with sleep apnea


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women >18 years of age Exclusion Criteria: significant medical conditions that would be expected to affect maternal- fetal outcomes need for admission to hospital, so that it transfer to the sleep would compromise maternal-fetal safety

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>Women with gestational hypertension | |
| No Intervention: 2<br>Women with uncomplicated pregnancies | Device: CPAP therapy for subjects diagnosed with sleep apnea<br>* CPAP therapy is being offered to women who are diagnosed on Polysomnogram with sleep apnea. However, this is not an intervention study and treatment is not part of the study protocol.<br>|
| No Intervention: 3<br>Re-test of women one to two years post-partum. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the prevalence of sleep apnea in preeclampsia and pregnancy. |  | Time of delivery for each woman | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| For those subjects diagnoses with sleep apnea: Improvement in blood pressure and electronic fetal monitoring during with use of CPAP. |  | Time of delivery for each woman | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preeclampsia, Sleep Apnea, CPAP