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Clinical Trials/NCT05908591
NCT05908591
Recruiting
Not Applicable

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

University of Alberta1 site in 1 country109 target enrollmentJanuary 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pregnancy Related
Sponsor
University of Alberta
Enrollment
109
Locations
1
Primary Endpoint
Endothelial Function
Status
Recruiting
Last Updated
12 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2023
End Date
April 18, 2027
Last Updated
12 months ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

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

Outcomes

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

  • Fasted blood sample - metabolic(20-24 weeks and 28-36 weeks gestation)
  • Cardiovascular Function - resting blood pressure(20-24 weeks and 28-36 weeks gestation)
  • Fasted blood sample - blood viscosity(20-24 weeks and 28-36 weeks gestation)
  • Fasted blood sample - sex hormone levels(20-24 weeks and 28-36 weeks gestation)
  • Maternal outcomes - delivery(2 months postpartum)
  • Fetal outcomes at delivery - birth mode(2 months postpartum)
  • Fetal outcomes at delivery - time spent in NICU(2 months postpartum)
  • Maternal outcome - amount of activity(20-24 weeks and 28-36 weeks)
  • Fetal outcomes at delivery - birth length(2 months postpartum)
  • Fetal outcomes at delivery - apgar score(2 months postpartum)
  • Cardiovascular Function - arterial stiffness with beat-by-beat blood pressure(20-24 weeks and 28-36 weeks gestation)
  • Cardiovascular Function - heart rate(20-24 weeks and 28-36 weeks gestation)
  • Maternal outcome - dietary intake(20-24 weeks and 28-36 weeks gestation)
  • Fasted blood sample - presence of inflammatory markers(20-24 weeks and 28-36 weeks gestation)
  • Fetal outcomes at delivery - birth weight(2 months postpartum)
  • Fetal outcomes at delivery - gestational age(2 months postpartum)
  • Cardiovascular Function - arterial stiffness with pulse wave velocity(20-24 weeks and 28-36 weeks gestation)
  • Cardiovascular Function - arrythmias(20-24 weeks and 28-36 weeks gestation)
  • Fetal outcomes at delivery - infant sex(2 months postpartum)
  • Cardiovascular Function - ambulatory blood pressure(20-24 weeks and 28-36 weeks gestation)
  • Maternal outcome - Mood - State-Trait Anxiety Inventory(20-24 weeks and 28-36 weeks)
  • Maternal outcome - Mood - Edinburgh Postnatal Depression Scale(20-24 weeks and 28-36 weeks)

Study Sites (1)

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