Clinical trial NCT05908591: Sleep Disordered Breathing, Endothelial Function, and Adverse Events in Pregnancy
Official title: SLEEP: Sleep Disordered Breathing, Endothelial Function, and Adverse Events in Pregnancy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pregnancy Related
Sleep-Disordered Breathing
Keywords: Cardiovascular Health
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 109
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant individuals with and without symptoms of sleep disordered breathing.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Endothelial Function
timeFrame: 20-24 weeks and 28-36 weeks gestation
Secondary outcomes:
measure: Cardiovascular Function - arterial stiffness with pulse wave velocity
timeFrame: 20-24 weeks and 28-36 weeks gestation
measure: Cardiovascular Function - arterial stiffness with beat-by-beat blood pressure
timeFrame: 20-24 weeks and 28-36 weeks gestation
measure: Cardiovascular Function - ambulatory blood pressure
timeFrame: 20-24 weeks and 28-36 weeks gestation
measure: Cardiovascular Function - resting blood pressure
timeFrame: 20-24 weeks and 28-36 weeks gestation
measure: Cardiovascular Function - heart rate
timeFrame: 20-24 weeks and 28-36 weeks gestation
measure: Cardiovascular Function - arrythmias
timeFrame: 20-24 weeks and 28-36 weeks gestation
measure: Maternal outcome - dietary intake
timeFrame: 20-24 weeks and 28-36 weeks gestation
measure: Fasted blood sample - blood viscosity
timeFrame: 20-24 weeks and 28-36 weeks gestation
measure: Fasted blood sample - presence of inflammatory markers
timeFrame: 20-24 weeks and 28-36 weeks gestation
measure: Fasted blood sample - sex hormone levels
timeFrame: 20-24 weeks and 28-36 weeks gestation
measure: Fasted blood sample - metabolic
timeFrame: 20-24 weeks and 28-36 weeks gestation
measure: Maternal outcomes - delivery
timeFrame: 2 months postpartum
measure: Fetal outcomes at delivery - infant sex
timeFrame: 2 months postpartum
measure: Fetal outcomes at delivery - birth weight
timeFrame: 2 months postpartum
measure: Fetal outcomes at delivery - birth length
timeFrame: 2 months postpartum
measure: Fetal outcomes at delivery - gestational age
timeFrame: 2 months postpartum
measure: Fetal outcomes at delivery - birth mode
timeFrame: 2 months postpartum
measure: Fetal outcomes at delivery - apgar score
timeFrame: 2 months postpartum
measure: Fetal outcomes at delivery - time spent in NICU
timeFrame: 2 months postpartum
measure: Maternal outcome - amount of activity
timeFrame: 20-24 weeks and 28-36 weeks
measure: Maternal outcome - Mood - State-Trait Anxiety Inventory
timeFrame: 20-24 weeks and 28-36 weeks
measure: Maternal outcome - Mood - Edinburgh Postnatal Depression Scale
timeFrame: 20-24 weeks and 28-36 weeks
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Program for Pregnancy and Postpartum Health, University of Alberta
state: Alberta
Study officials:
References: