Sleep Disordered Breathing, Endothelial Function, and Adverse Events in Pregnancy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Pregnancy Related, Sleep-Disordered Breathing. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
SLEEP: Sleep Disordered Breathing, Endothelial Function, and Adverse Events in Pregnancy
Overview
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.
Primary outcome measures
- Endothelial Function [Time frame: 20-24 weeks and 28-36 weeks gestation]
Secondary outcome measures (12)
- Cardiovascular Function - arterial stiffness with pulse wave velocity [Time frame: 20-24 weeks and 28-36 weeks gestation]
- Cardiovascular Function - arterial stiffness with beat-by-beat blood pressure [Time frame: 20-24 weeks and 28-36 weeks gestation]
- Cardiovascular Function - ambulatory blood pressure [Time frame: 20-24 weeks and 28-36 weeks gestation]
- Cardiovascular Function - resting blood pressure [Time frame: 20-24 weeks and 28-36 weeks gestation]
- Cardiovascular Function - heart rate [Time frame: 20-24 weeks and 28-36 weeks gestation]
- Cardiovascular Function - arrythmias [Time frame: 20-24 weeks and 28-36 weeks gestation]
- Maternal outcome - dietary intake [Time frame: 20-24 weeks and 28-36 weeks gestation]
- Fasted blood sample - blood viscosity [Time frame: 20-24 weeks and 28-36 weeks gestation]
- Fasted blood sample - presence of inflammatory markers [Time frame: 20-24 weeks and 28-36 weeks gestation]
- Fasted blood sample - sex hormone levels [Time frame: 20-24 weeks and 28-36 weeks gestation]
- Fasted blood sample - metabolic [Time frame: 20-24 weeks and 28-36 weeks gestation]
- Maternal outcomes - delivery [Time frame: 2 months postpartum]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Canada · 1 center
- Program for Pregnancy and Postpartum Health, University of Alberta — Edmonton
Identifiers
NCT: NCT05908591 · Pro00110658