Sleep Disordered Breathing, Endothelial Function, and Adverse Events in Pregnancy

Study Overview
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Brief Summary
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This is a prospective longitudinal cohort study whereby pregnant individuals are asked to complete an 8-day testing protocol to measure their sleep and cardiovascular health at two timepoints during pregnancy.

Detailed Description
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The goal of this observational study is to examine the effect of sleep disordered breathing on the health of the heart and blood vessels of the mother during pregnancy. The main questions it aims to answer are: Is sleep disordered breathing associated with impaired the function of the heart and blood vessels in pregnancy? Is higher levels of physical activity associated with a reduced risk of sleep disordered breathing in pregnancy? Participants will complete an 8 day long study protocol at two time points during pregnancy (20-24 weeks gestation and 28-36 weeks gestation). During each testing period they will be asked to: Complete one night of at-home sleep testing and and one night of overnight vital signs monitoring (ambulatory blood pressure and heart rate monitoring devices) Wear two accelerometers and complete a 7-day sleep log Complete a set of questionnaires Visit the laboratory for a fasted blood draw and ultrasound assessment of their cardiovascular health (resting heart rate and blood pressure, flow mediated dilation and pulse wave velocity tests) Participants will also be asked to complete a short follow-up survey in the postpartum period.

Official Title
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SLEEP: Sleep Disordered Breathing, Endothelial Function, and Adverse Events in Pregnancy

Conditions
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Pregnancy Related, Sleep-Disordered Breathing

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: over 18 years of age pregnant (20-24 weeks gestation at enrollment) Exclusion Criteria: worked shift work past 11pm in the previous month previously diagnosed with a sleep disorder by a physician

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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial Function | The investigators will assess endothelial function using flow mediated dilation | 20-24 weeks and 28-36 weeks gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular Function - arterial stiffness with pulse wave velocity | The investigators will measure arterial stiffness using pulse wave velocity of the carotid and femoral arteries | 20-24 weeks and 28-36 weeks gestation | 
| Cardiovascular Function - arterial stiffness with beat-by-beat blood pressure | The investigators will measure arterial stiffness using beat-by-beat blood pressure from the finger. | 20-24 weeks and 28-36 weeks gestation | 
| Cardiovascular Function - ambulatory blood pressure | Blood pressure will be collected every 30 minutes during a 24-hour period using an ambulatory blood pressure monitor. | 20-24 weeks and 28-36 weeks gestation | 
| Cardiovascular Function - resting blood pressure | Beat-by-beat blood pressure will be collected at rest. | 20-24 weeks and 28-36 weeks gestation | 
| Cardiovascular Function - heart rate | Heart rate will be assessed by 3-lead ECG collected during sleep and at rest. | 20-24 weeks and 28-36 weeks gestation | 
| Cardiovascular Function - arrythmias | Presence of arrythmias will be assessed by 3-lead ECG collected during sleep and at rest. | 20-24 weeks and 28-36 weeks gestation | 
| Maternal outcome - dietary intake | Participants will complete two 3-day food logs. | 20-24 weeks and 28-36 weeks gestation | 
| Fasted blood sample - blood viscosity | Fasted blood samples will be analyzed using a viscometer. | 20-24 weeks and 28-36 weeks gestation | 
| Fasted blood sample - presence of inflammatory markers | Fasted blood samples will be analyzed for C-reactive protein. | 20-24 weeks and 28-36 weeks gestation | 
| Fasted blood sample - sex hormone levels | Fasted blood samples will be analyzed for sex hormone levels (estrogen, progesterone, testosterone). | 20-24 weeks and 28-36 weeks gestation | 
| Fasted blood sample - metabolic | Fasted blood samples will be analyzed for glucose and insulin concentration. | 20-24 weeks and 28-36 weeks gestation | 
| Maternal outcomes - delivery | Participants will provide the investigators with information regarding delivery and pregnancy complications (gestational diabetes, pregnancy induced hypertension, preeclampsia). | 2 months postpartum | 
| Fetal outcomes at delivery - infant sex | Participants will provide the investigators with information regarding infant sex. | 2 months postpartum | 
| Fetal outcomes at delivery - birth weight | Participants will provide the investigators with information regarding infant birth weight. | 2 months postpartum | 
| Fetal outcomes at delivery - birth length | Participants will provide the investigators with information regarding birth length. | 2 months postpartum | 
| Fetal outcomes at delivery - gestational age | Participants will provide the investigators with information regarding gestational age at delivery. | 2 months postpartum | 
| Fetal outcomes at delivery - birth mode | Participants will provide the investigators with information regarding birth mode. | 2 months postpartum | 
| Fetal outcomes at delivery - apgar score | Participants will provide the investigators with information regarding infant apgar score at delivery. | 2 months postpartum | 
| Fetal outcomes at delivery - time spent in NICU | Participants will provide the investigators with information regarding infant time spent in neonatal intensive care unit (NICU). | 2 months postpartum | 
| Maternal outcome - amount of activity | Participants will wear two accelerometers to measure the amount of physical activity performed. | 20-24 weeks and 28-36 weeks | 
| Maternal outcome - Mood - State-Trait Anxiety Inventory | Participants will complete the State-Trait Anxiety Inventory to measure mood. | 20-24 weeks and 28-36 weeks | 
| Maternal outcome - Mood - Edinburgh Postnatal Depression Scale | Participants will complete the Edinburgh Postnatal Depression Scale to measure mood. | 20-24 weeks and 28-36 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiovascular Health