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

Pregnancy Related Clinical Trial

— SLEEP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05908591
• Other study ID #: Pro00110658
• Status: Recruiting
• Start date: January 1, 2023
• Est. completion date: August 2024

Study information

• Verified date: March 2024
• Source: University of Alberta
• Contact: Margie Davenport, PhD
• Phone: 780-492-0642
• Email: mdavenpo[@]ualberta.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 109
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy Related
• Respiratory Aspiration
• Sleep Apnea Syndromes
• Sleep-Disordered Breathing

Locations

Country	Name	City	State
Canada	Program for Pregnancy and Postpartum Health, University of Alberta	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelial Function	The investigators will assess endothelial function using flow mediated dilation	20-24 weeks and 28-36 weeks gestation
Secondary	Cardiovascular Function - arterial stiffness with pulse wave velocity	The investigators will measure arterial stiffness using pulse wave velocity of the carotid and femoral arteries	20-24 weeks and 28-36 weeks gestation
Secondary	Cardiovascular Function - arterial stiffness with beat-by-beat blood pressure	The investigators will measure arterial stiffness using beat-by-beat blood pressure from the finger.	20-24 weeks and 28-36 weeks gestation
Secondary	Cardiovascular Function - ambulatory blood pressure	Blood pressure will be collected every 30 minutes during a 24-hour period using an ambulatory blood pressure monitor.	20-24 weeks and 28-36 weeks gestation
Secondary	Cardiovascular Function - resting blood pressure	Beat-by-beat blood pressure will be collected at rest.	20-24 weeks and 28-36 weeks gestation
Secondary	Cardiovascular Function - heart rate	Heart rate will be assessed by 3-lead ECG collected during sleep and at rest.	20-24 weeks and 28-36 weeks gestation
Secondary	Cardiovascular Function - arrythmias	Presence of arrythmias will be assessed by 3-lead ECG collected during sleep and at rest.	20-24 weeks and 28-36 weeks gestation
Secondary	Maternal outcome - dietary intake	Participants will complete two 3-day food logs.	20-24 weeks and 28-36 weeks gestation
Secondary	Fasted blood sample - blood viscosity	Fasted blood samples will be analyzed using a viscometer.	20-24 weeks and 28-36 weeks gestation
Secondary	Fasted blood sample - presence of inflammatory markers	Fasted blood samples will be analyzed for C-reactive protein.	20-24 weeks and 28-36 weeks gestation
Secondary	Fasted blood sample - sex hormone levels	Fasted blood samples will be analyzed for sex hormone levels (estrogen, progesterone, testosterone).	20-24 weeks and 28-36 weeks gestation
Secondary	Fasted blood sample - metabolic	Fasted blood samples will be analyzed for glucose and insulin concentration.	20-24 weeks and 28-36 weeks gestation
Secondary	Maternal outcomes - delivery	Participants will provide the investigators with information regarding delivery and pregnancy complications (gestational diabetes, pregnancy induced hypertension, preeclampsia).	2 months postpartum
Secondary	Fetal outcomes at delivery - infant sex	Participants will provide the investigators with information regarding infant sex.	2 months postpartum
Secondary	Fetal outcomes at delivery - birth weight	Participants will provide the investigators with information regarding infant birth weight.	2 months postpartum
Secondary	Fetal outcomes at delivery - birth length	Participants will provide the investigators with information regarding birth length.	2 months postpartum
Secondary	Fetal outcomes at delivery - gestational age	Participants will provide the investigators with information regarding gestational age at delivery.	2 months postpartum
Secondary	Fetal outcomes at delivery - birth mode	Participants will provide the investigators with information regarding birth mode.	2 months postpartum
Secondary	Fetal outcomes at delivery - apgar score	Participants will provide the investigators with information regarding infant apgar score at delivery.	2 months postpartum
Secondary	Fetal outcomes at delivery - time spent in NICU	Participants will provide the investigators with information regarding infant time spent in neonatal intensive care unit (NICU).	2 months postpartum
Secondary	Maternal outcome - amount of activity	Participants will wear two accelerometers to measure the amount of physical activity performed.	20-24 weeks and 28-36 weeks
Secondary	Maternal outcome - Mood - State-Trait Anxiety Inventory	Participants will complete the State-Trait Anxiety Inventory to measure mood.	20-24 weeks and 28-36 weeks
Secondary	Maternal outcome - Mood - Edinburgh Postnatal Depression Scale	Participants will complete the Edinburgh Postnatal Depression Scale to measure mood.	20-24 weeks and 28-36 weeks