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

U

University of Alberta

Status

Enrolling

Conditions

Pregnancy Related
Sleep-Disordered Breathing

Study type

Observational

Funder types

Other

Identifiers

NCT05908591
Pro00110658

Details and patient eligibility

About

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.

Full 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.

Enrollment

109 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Craig Steinback, PhD; Margie Davenport, PhD

Data sourced from clinicaltrials.gov

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