NCT05908591

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P50-P75 for all trials

Timeline
11mo left

Started Jan 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress78%
Jan 2023Apr 2027

Study Start

First participant enrolled

January 1, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 18, 2027

Last Updated

May 7, 2025

Status Verified

May 1, 2025

Enrollment Period

4.3 years

First QC Date

May 17, 2023

Last Update Submit

May 5, 2025

Conditions

Pregnancy RelatedSleep-Disordered Breathing

Keywords

Cardiovascular Health

Outcome Measures

Primary Outcomes (1)

  • Endothelial Function

    The investigators will assess endothelial function using flow mediated dilation

    20-24 weeks and 28-36 weeks gestation

Secondary Outcomes (22)

  • Cardiovascular Function - arterial stiffness with pulse wave velocity

    20-24 weeks and 28-36 weeks gestation

  • Cardiovascular Function - arterial stiffness with beat-by-beat blood pressure

    20-24 weeks and 28-36 weeks gestation

  • Cardiovascular Function - ambulatory blood pressure

    20-24 weeks and 28-36 weeks gestation

  • Cardiovascular Function - resting blood pressure

    20-24 weeks and 28-36 weeks gestation

  • Cardiovascular Function - heart rate

    20-24 weeks and 28-36 weeks gestation

  • +17 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pregnant individuals with and without symptoms of sleep disordered breathing.

You may qualify if:

  • over 18 years of age
  • pregnant (20-24 weeks gestation at enrollment)

You may not qualify if:

  • worked shift work past 11pm in the previous month
  • previously diagnosed with a sleep disorder by a physician

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Program for Pregnancy and Postpartum Health, University of Alberta

Edmonton, Alberta, T6G 2E1, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood serum

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Central Study Contacts

Margie Davenport, PhD

CONTACT

780-492-0642mdavenpo@ualberta.ca

Craig Steinback, PhD

CONTACT

780-492-5553craig.steinback@ualberta.ca

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2023

First Posted

June 18, 2023

Study Start

January 1, 2023

Primary Completion (Estimated)

April 18, 2027

Study Completion (Estimated)

April 18, 2027

Last Updated

May 7, 2025

Record last verified: 2025-05

Locations

CA(1)