Pregnancy RelatedSLEEPNCT05908591
Sleep Disordered Breathing, Endothelial Function, and Adverse Events in Pregnancy
An observational study of Pregnancy Related and Sleep-Disordered Breathing, run by University of Alberta at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Sleep-Disordered Breathing
- How many people
- 109 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2023to 18 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pregnant individuals with and without symptoms of sleep disordered breathing.
Who may be able to join
- over 18 years of age
- pregnant (20-24 weeks gestation at enrollment)
Who cannot join
- worked shift work past 11pm in the previous month
- previously diagnosed with a sleep disorder by a physician
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Program for Pregnancy and Postpartum Health, University of Alberta
Edmonton, Alberta, T6G 2E1
Margie Davenport, PhD, 780-492-0642, mdavenpo@ualberta.ca
Brittany Matenchuk, MSc
About this study
Official title: SLEEP: Sleep Disordered Breathing, Endothelial Function, and Adverse Events in Pregnancy
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.
Read the 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.
- Conditions
- Pregnancy Related, Sleep-Disordered Breathing
- Keywords
- Cardiovascular Health
- Medical subject headings
- Sleep Apnea Syndromes
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial Function
The investigators will assess endothelial function using flow mediated dilation
Measured: 20-24 weeks and 28-36 weeks gestation
Secondary outcomes (22)
Cardiovascular Function - arterial stiffness with pulse wave velocity
The investigators will measure arterial stiffness using pulse wave velocity of the carotid and femoral arteries
Measured: 20-24 weeks and 28-36 weeks gestation
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.
Measured: 20-24 weeks and 28-36 weeks gestation
Cardiovascular Function - ambulatory blood pressure
Blood pressure will be collected every 30 minutes during a 24-hour period using an ambulatory blood pressure monitor.
Measured: 20-24 weeks and 28-36 weeks gestation
Cardiovascular Function - resting blood pressure
Beat-by-beat blood pressure will be collected at rest.
Measured: 20-24 weeks and 28-36 weeks gestation
Cardiovascular Function - heart rate
Heart rate will be assessed by 3-lead ECG collected during sleep and at rest.
Measured: 20-24 weeks and 28-36 weeks gestation
Cardiovascular Function - arrythmias
Presence of arrythmias will be assessed by 3-lead ECG collected during sleep and at rest.
Measured: 20-24 weeks and 28-36 weeks gestation
Maternal outcome - dietary intake
Participants will complete two 3-day food logs.
Measured: 20-24 weeks and 28-36 weeks gestation
Fasted blood sample - blood viscosity
Fasted blood samples will be analyzed using a viscometer.
Measured: 20-24 weeks and 28-36 weeks gestation
Fasted blood sample - presence of inflammatory markers
Fasted blood samples will be analyzed for C-reactive protein.
Measured: 20-24 weeks and 28-36 weeks gestation
Fasted blood sample - sex hormone levels
Fasted blood samples will be analyzed for sex hormone levels (estrogen, progesterone, testosterone).
Measured: 20-24 weeks and 28-36 weeks gestation
Fasted blood sample - metabolic
Fasted blood samples will be analyzed for glucose and insulin concentration.
Measured: 20-24 weeks and 28-36 weeks gestation
Maternal outcomes - delivery
Participants will provide the investigators with information regarding delivery and pregnancy complications (gestational diabetes, pregnancy induced hypertension, preeclampsia).
Measured: 2 months postpartum
Fetal outcomes at delivery - infant sex
Participants will provide the investigators with information regarding infant sex.
Measured: 2 months postpartum
Fetal outcomes at delivery - birth weight
Participants will provide the investigators with information regarding infant birth weight.
Measured: 2 months postpartum
Fetal outcomes at delivery - birth length
Participants will provide the investigators with information regarding birth length.
Measured: 2 months postpartum
Fetal outcomes at delivery - gestational age
Participants will provide the investigators with information regarding gestational age at delivery.
Measured: 2 months postpartum
Fetal outcomes at delivery - birth mode
Participants will provide the investigators with information regarding birth mode.
Measured: 2 months postpartum
Fetal outcomes at delivery - apgar score
Participants will provide the investigators with information regarding infant apgar score at delivery.
Measured: 2 months postpartum
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).
Measured: 2 months postpartum
Maternal outcome - amount of activity
Participants will wear two accelerometers to measure the amount of physical activity performed.
Measured: 20-24 weeks and 28-36 weeks
Maternal outcome - Mood - State-Trait Anxiety Inventory
Participants will complete the State-Trait Anxiety Inventory to measure mood.
Measured: 20-24 weeks and 28-36 weeks
Maternal outcome - Mood - Edinburgh Postnatal Depression Scale
Participants will complete the Edinburgh Postnatal Depression Scale to measure mood.
Measured: 20-24 weeks and 28-36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start1 Jan 2023
- Primary completion18 Apr 2027 (estimated)
- Study completion18 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 109 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05908591
- Sponsor's protocol ID
- Pro00110658
- Acronym
- SLEEP
- Status last verified
- Jul 2026
- First submitted
- 17 May 2023
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SLEEP: Sleep Disordered Breathing, Endothelial Function, and Adverse Events in Pregnancy
- ClinicalTrials.gov ID
- NCT05908591
- Acronym / sponsor ID
- SLEEP / Pro00110658
- Conditions
- Pregnancy Related, Sleep-Disordered Breathing
- Keywords
- Cardiovascular Health
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 109 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 18 Apr 2027 (estimated)
- Study completion
- 18 Apr 2027 (estimated)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant individuals with and without symptoms of sleep disordered breathing.
Key inclusion criteria (2 listed)
- over 18 years of age
- pregnant (20-24 weeks gestation at enrollment)
Key exclusion criteria (2 listed)
- worked shift work past 11pm in the previous month
- previously diagnosed with a sleep disorder by a physician
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Endothelial Function
Time frame: 20-24 weeks and 28-36 weeks gestation
The investigators will assess endothelial function using flow mediated dilation
22 secondary outcomes
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
Fetal outcomes at delivery - infant sex
Time frame: 2 months postpartum
Fetal outcomes at delivery - birth weight
Time frame: 2 months postpartum
Fetal outcomes at delivery - birth length
Time frame: 2 months postpartum
Fetal outcomes at delivery - gestational age
Time frame: 2 months postpartum
Fetal outcomes at delivery - birth mode
Time frame: 2 months postpartum
Fetal outcomes at delivery - apgar score
Time frame: 2 months postpartum
Fetal outcomes at delivery - time spent in NICU
Time frame: 2 months postpartum
Maternal outcome - amount of activity
Time frame: 20-24 weeks and 28-36 weeks
Maternal outcome - Mood - State-Trait Anxiety Inventory
Time frame: 20-24 weeks and 28-36 weeks
Maternal outcome - Mood - Edinburgh Postnatal Depression Scale
Time frame: 20-24 weeks and 28-36 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related and Sleep-Disordered Breathing, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Margie Davenport, PhD (780-492-0642, mdavenpo@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endothelial Function (time frame: 20-24 weeks and 28-36 weeks gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.