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

NCT ID: NCT05908591

Last Updated: 2025-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

109 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2027-04-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pregnancy Related Sleep-Disordered Breathing

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Alberta

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Program for Pregnancy and Postpartum Health, University of Alberta

Edmonton, Alberta, Canada

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Canada

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Margie Davenport, PhD

Role: CONTACT

780-492-0642

Craig Steinback, PhD

Role: CONTACT

780-492-5553

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Margie Davenport, PhD

Role: primary

780-492-0642

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Pro00110658

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Sleep Measurement Study
NCT04288557 COMPLETED