Program for Pregnancy and Postpartum Health, University of Alberta
Edmonton, Alberta, T6G 2E1, Canada
Location status: Recruiting
Location contact
Brittany Matenchuk, MSc
SUB_INVESTIGATOR
Margie Davenport, PhD
CONTACT
Recruiting
NCT Number: NCT05908591
Sleep Disordered Breathing, Endothelial Function, and Adverse Events in Pregnancy
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
Female
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Endothelial Function
Time frame: 20-24 weeks and 28-36 weeks gestation
The investigators will assess endothelial function using flow mediated dilation
Secondary outcomes
-
Cardiovascular Function - arterial stiffness with pulse wave velocity
Time frame: 20-24 weeks and 28-36 weeks gestation
The investigators will measure arterial stiffness using pulse wave velocity of the carotid and femoral arteries
-
Cardiovascular Function - arterial stiffness with beat-by-beat blood pressure
Time frame: 20-24 weeks and 28-36 weeks gestation
The investigators will measure arterial stiffness using beat-by-beat blood pressure from the finger.
-
Cardiovascular Function - ambulatory blood pressure
Time frame: 20-24 weeks and 28-36 weeks gestation
Blood pressure will be collected every 30 minutes during a 24-hour period using an ambulatory blood pressure monitor.
-
Cardiovascular Function - resting blood pressure
Time frame: 20-24 weeks and 28-36 weeks gestation
Beat-by-beat blood pressure will be collected at rest.
-
Cardiovascular Function - heart rate
Time frame: 20-24 weeks and 28-36 weeks gestation
Heart rate will be assessed by 3-lead ECG collected during sleep and at rest.
-
Cardiovascular Function - arrythmias
Time frame: 20-24 weeks and 28-36 weeks gestation
Presence of arrythmias will be assessed by 3-lead ECG collected during sleep and at rest.
-
Maternal outcome - dietary intake
Time frame: 20-24 weeks and 28-36 weeks gestation
Participants will complete two 3-day food logs.
-
Fasted blood sample - blood viscosity
Time frame: 20-24 weeks and 28-36 weeks gestation
Fasted blood samples will be analyzed using a viscometer.
-
Fasted blood sample - presence of inflammatory markers
Time frame: 20-24 weeks and 28-36 weeks gestation
Fasted blood samples will be analyzed for C-reactive protein.
-
Fasted blood sample - sex hormone levels
Time frame: 20-24 weeks and 28-36 weeks gestation
Fasted blood samples will be analyzed for sex hormone levels (estrogen, progesterone, testosterone).
-
Fasted blood sample - metabolic
Time frame: 20-24 weeks and 28-36 weeks gestation
Fasted blood samples will be analyzed for glucose and insulin concentration.
-
Maternal outcomes - delivery
Time frame: 2 months postpartum
Participants will provide the investigators with information regarding delivery and pregnancy complications (gestational diabetes, pregnancy induced hypertension, preeclampsia).
-
Fetal outcomes at delivery - infant sex
Time frame: 2 months postpartum
Participants will provide the investigators with information regarding infant sex.
-
Fetal outcomes at delivery - birth weight
Time frame: 2 months postpartum
Participants will provide the investigators with information regarding infant birth weight.
-
Fetal outcomes at delivery - birth length
Time frame: 2 months postpartum
Participants will provide the investigators with information regarding birth length.
-
Fetal outcomes at delivery - gestational age
Time frame: 2 months postpartum
Participants will provide the investigators with information regarding gestational age at delivery.
-
Fetal outcomes at delivery - birth mode
Time frame: 2 months postpartum
Participants will provide the investigators with information regarding birth mode.
-
Fetal outcomes at delivery - apgar score
Time frame: 2 months postpartum
Participants will provide the investigators with information regarding infant apgar score at delivery.
-
Fetal outcomes at delivery - time spent in NICU
Time frame: 2 months postpartum
Participants will provide the investigators with information regarding infant time spent in neonatal intensive care unit (NICU).
-
Maternal outcome - amount of activity
Time frame: 20-24 weeks and 28-36 weeks
Participants will wear two accelerometers to measure the amount of physical activity performed.
-
Maternal outcome - Mood - State-Trait Anxiety Inventory
Time frame: 20-24 weeks and 28-36 weeks
Participants will complete the State-Trait Anxiety Inventory to measure mood.
-
Maternal outcome - Mood - Edinburgh Postnatal Depression Scale
Time frame: 20-24 weeks and 28-36 weeks
Participants will complete the Edinburgh Postnatal Depression Scale to measure mood.
Study contacts
Contact information is provided by the study sponsor or research team.
Craig Steinback, PhD
CONTACT
Margie Davenport, PhD
CONTACT
Sponsors and collaborators
Lead sponsor
University of Alberta
Other
Registry information
Official study title
SLEEP: Sleep Disordered Breathing, Endothelial Function, and Adverse Events in Pregnancy
Acronym: SLEEP
Important dates
- Study start
- 2023
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Jun 18, 2023
- Registry last updated
- Jul 17, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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