Pre-EclampsiaNCT06702475
Are There Sleep-related Factors That Contribute to an Increased Incidence of Pre-eclampsia at Altitude?
An observational study of Pre-Eclampsia, run by University of Colorado, Denver.
Trial summary
Women at altitude have an increased incidence of pre-eclampsia. Populations at altitude have a greater incidence of sleep apnea. And women with sleep apnea are at increased risk of developing preeclampsia. Read more about this study
- Who is it for?
- Ages 18 to 36 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pre-Eclampsia
- What is being tested?
- Home Sleep Test with Watch PAT-one
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2025to 1 Dec 2026
- 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 to 36 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: pregnant women, age 15-35, some who are healthy, and some who have developed preeclampsia.
Inclusion Criteria: pregnant, age 18-35, possession of, or availablitiy of using a cell phone.
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Exclusion Criteria: for the control group the following are exclusion criteria: hypertension, known sleep apnea, asthma requiring daily inhaler use, other lung disease, diabetes
For the group who are recruited at the time of diagnosis of pre-eclampsia - hypertension is not an exclusion criteria.
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Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Are There Sleep-related Factors That Contribute to an Increased Incidence of Pre-eclampsia
Women at altitude have an increased incidence of pre-eclampsia. Populations at altitude have a greater incidence of sleep apnea. And women with sleep apnea are at increased risk of developing preeclampsia. This research project will recruit for home sleep testing: healthy pregnant women at altitude (Summit County , Colorado at 9000 ft.), and women with preeclampsia at altitude, in order to learn whether either sleep apnea or nocturnal hypoxemia is more common or more severe in women with preeclampsia, than in healthy women at altitude. In addition a healthy co-hort of pregnant women will be studied at sea level, to compare to the healthy cohort of pregnant woman in Summit County, to learn to degree that this difference in altitude effects the severity of sleep apnea and hypoxemia.
Read the detailed description
It is known that high altitude increases the risk of preeclampsia and small for gestational age births. Our questions are: 1). Is sleep apnea during pregnancy more common and/or more severe at altitude? And 2) Do the women who develop preeclampsia at altitude have more severe sleep apnea, or worse hypoxemia during sleep, than the women at altitude who do not develop preeclampsia. We will perform WatchPAT-one home sleep tests (PAT = peripheral arterial tonometry) on up to 20 pregnant women in Summit County Colorado (>9000 ft.elevation) who develop preeclampsia during pregnancy (soon after diagnosis), and also on up to 20 pregnant healthy women in Summit County, and 20 healthy pregnant women in Baltimore (at sea level). These healthy pregnant women in Summit County and Baltimore will be selected from volunteer participants, to best match age, pre-pregnancy BMI, and race with individuals in Summit County who are studied with preeclampsia and they will be studied at the gestational timing that matches their Summit County preeclampsia matching subject. In addition to the up to 20 healthy pregnant subjects at Summit County and 20 in Baltimore, who match the preeclampsia subjects, we will recruit up to 20 more in Summit County and 20 more in Baltimore, to study specifically in the 33rd or 34th gestational week, to improve our ability to evaluate the effects of altitude on sleep apnea, during pregnancy. Information on the births, including height and weight and apgar scores will be assessed, in part to see whether sleep apnea during pregnancy affects outcomes. All sleep studies will be scored at the JHH (Johns Hopkins Hospital) Bayview sleep lab's Center for Interdisciplinary Sleep Research and Education.
- Conditions
- Pre-Eclampsia
- Being tested
- Home Sleep Test with Watch PAT-one
- Keywords
- Pre-Eclampsia, Altitude, Sleep Apnea
- Medical subject headings
- Pre-Eclampsia, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home Sleep Test with Watch PAT-oneDiagnostic test
Each participant will have a Watch-PAT one home sleep test, recording pulse oximetry, pulse tonometry, wrist actigraphy, snoring (by microphone), and chest motion by accelerometer.
| Study group | Role | What they receive |
|---|---|---|
| pregnant with pre-eclampsia at altitude (Cohort 1) | Pregnant women at High Country Obstetric Clinic in Summit County Colorado (about 9000 ft.) who develop pre-eclampsia.
Home sleep testing with Watch PAT-one will be done soon after diagnosis of pre-eclampsia.
Up to 20 in this cohort Receives: Diagnostic Test: Home Sleep Test with Watch PAT-one | |
| healthy pregnant women at altitude (Cohort 2) | Pregnant healthy women at High Country Obstetric Clinc in Summit County Colorado will also be studied with the Watch PAT-one home sleep test..
Up to 20 will be chosen to match the subjects, 1 by 1, in cohort 1, regarding gestational time of the home sleep test, and match age, pre-pregnant BMI, and race as best as available of the volunteered subjects. Up to another 20 pregnant healthy women at altitude may be recruited, not matching a subject in cohort 1, to have Watch PAT-one home sleep testing in the 33rd to 34th week of pregnancy. Receives: Diagnostic Test: Home Sleep Test with Watch PAT-one | |
| healthy pregnant women at sea level (Cohort 3) | Up to 40 healthy pregnant women at sea level, in vicinity of Baltimore, will be recruited to have Watch PAT-one home sleep testing, matching the subjects in cohort 2 regarding gestational time of testing, Race, Age and pre-pregnant BMI as best as available. Receives: Diagnostic Test: Home Sleep Test with Watch PAT-one |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea-Hypopnea index 4%
number of apneas and hypopneas dropping oxygen saturation 4%, per hour
Measured: in a single full night recording
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start1 Apr 2025 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-EclampsiaStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University
- Responsible party
- Principal investigator, David Patz, University of Colorado, Denver
- Investigators
- Cynthia Argani, MD, Study chair, Johns Hopkins Hospital OB-GYN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06702475
- Sponsor's protocol ID
- 23-1743
- Status last verified
- Nov 2024
- First submitted
- 20 Nov 2024
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data will likely be shared. The precise mechanism of sharing the data is not yet determined.
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are There Sleep-related Factors That Contribute to an Increased Incidence of Pre-eclampsia
- ClinicalTrials.gov ID
- NCT06702475
- Acronym / sponsor ID
- 23-1743
- Conditions
- Pre-Eclampsia
- Keywords
- Pre-Eclampsia, Altitude, Sleep Apnea
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Johns Hopkins University
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 25 Nov 2024 (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.
Women at altitude have an increased incidence of pre-eclampsia. Populations at altitude have a greater incidence of sleep apnea. And women with sleep apnea are at increased risk of developing preeclampsia. This research project will recruit for home sleep testing: healthy pregnant women at altitude (Summit County , Colorado at 9000 ft.), and women with preeclampsia at altitude, in order to learn whether either sleep apnea or nocturnal hypoxemia is more common or more severe in women with preeclampsia, than in healthy women at altitude. In addition a healthy co-hort of pregnant women will be studied at sea level, to compare to the healthy cohort of pregnant woman in Summit County, to learn to degree that this difference in altitude effects the severity of sleep apnea and hypoxemia.
Detailed description
It is known that high altitude increases the risk of preeclampsia and small for gestational age births. Our questions are: 1). Is sleep apnea during pregnancy more common and/or more severe at altitude? And 2) Do the women who develop preeclampsia at altitude have more severe sleep apnea, or worse hypoxemia during sleep, than the women at altitude who do not develop preeclampsia. We will perform WatchPAT-one home sleep tests (PAT = peripheral arterial tonometry) on up to 20 pregnant women in Summit County Colorado (>9000 ft.elevation) who develop preeclampsia during pregnancy (soon after diagnosis), and also on up to 20 pregnant healthy women in Summit County, and 20 healthy pregnant women in Baltimore (at sea level). These healthy pregnant women in Summit County and Baltimore will be selected from volunteer participants, to best match age, pre-pregnancy BMI, and race with individuals in Summit County who are studied with preeclampsia and they will be studied at the gestational timing that matches their Summit County preeclampsia matching subject. In addition to the up to 20 healthy pregnant subjects at Summit County and 20 in Baltimore, who match the preeclampsia subjects, we will recruit up to 20 more in Summit County and 20 more in Baltimore, to study specifically in the 33rd or 34th gestational week, to improve our ability to evaluate the effects of altitude on sleep apnea, during pregnancy. Information on the births, including height and weight and apgar scores will be assessed, in part to see whether sleep apnea during pregnancy affects outcomes. All sleep studies will be scored at the JHH (Johns Hopkins Hospital) Bayview sleep lab's Center for Interdisciplinary Sleep Research and Education.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| pregnant with pre-eclampsia at altitude (Cohort 1) | – | Diagnostic Test: Home Sleep Test with Watch PAT-onePregnant women at High Country Obstetric Clinic in Summit County Colorado (about 9000 ft.) who develop pre-eclampsia. Home sleep testing with Watch PAT-one will be done soon after diagnosis of pre-eclampsia. Up to 20 in this cohort |
| healthy pregnant women at altitude (Cohort 2) | – | Diagnostic Test: Home Sleep Test with Watch PAT-onePregnant healthy women at High Country Obstetric Clinc in Summit County Colorado will also be studied with the Watch PAT-one home sleep test.. Up to 20 will be chosen to match the subjects, 1 by 1, in cohort 1, regarding gestational time of the home sleep test, and match age, pre-pregnant BMI, and race as best as available of the volunteered subjects. Up to another 20 pregnant healthy women at altitude may be recruited, not matching a subject in cohort 1, to have Watch PAT-one home sleep testing in the 33rd to 34th week of pregnancy. |
| healthy pregnant women at sea level (Cohort 3) | – | Diagnostic Test: Home Sleep Test with Watch PAT-oneUp to 40 healthy pregnant women at sea level, in vicinity of Baltimore, will be recruited to have Watch PAT-one home sleep testing, matching the subjects in cohort 2 regarding gestational time of testing, Race, Age and pre-pregnant BMI as best as available. |
Who may qualify
- Ages
- 18 to 36 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- pregnant women, age 15-35, some who are healthy, and some who have developed preeclampsia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home Sleep Test with Watch PAT-oneEach participant will have a Watch-PAT one home sleep test, recording pulse oximetry, pulse tonometry, wrist actigraphy, snoring (by microphone), and chest motion by accelerometer. | Diagnostic test | healthy pregnant women at altitude (Cohort 2), healthy pregnant women at sea level (Cohort 3), pregnant with pre-eclampsia at altitude (Cohort 1) |
Primary outcome
Apnea-Hypopnea index 4%
Time frame: in a single full night recording
number of apneas and hypopneas dropping oxygen saturation 4%, per hour
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 25 Nov 2024.
- Individual participant dataSharing planned: Undecided. The data will likely be shared. The precise mechanism of sharing the data is not yet determined.
Related trials for Pre-Eclampsia
Recruiting
Exercise to Improve Heart and Metabolic Health After Childbirth in Women at High Risk for Preeclampsia
Postpartum Exercise, Cardiometabolic Health
RecruitingObservational study
Molecular Study of the Maternal-fetal Interface in Preeclampsia.
Preeclampsia
Active, not recruitingObservational study
The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
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.
Cynthia Argani, MD study chair
Johns Hopkins Hospital OB-GYN
Questions about this trial
What is this clinical trial studying?
An observational study of Pre-Eclampsia, run by University of Colorado, Denver.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: opening soon, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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 DAVID S PATZ, MD (9706407240, david.patz@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea-Hypopnea index 4% (time frame: in a single full night recording). 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 25 Nov 2024.