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Are There Sleep-related Factors That Contribute to an Increased Incidence of Pre-eclampsia at Altitude?

Are There Sleep-related Factors That Contribute to an Increased Incidence of Pre-eclampsia

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06702475
Enrollment
100
Registered
2024-11-25
Start date
2025-04-01
Completion date
2026-12-01
Last updated
2024-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pre-Eclampsia

Keywords

Pre-Eclampsia, Altitude, Sleep Apnea

Brief 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. 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.

Interventions

DIAGNOSTIC_TESTHome Sleep Test with Watch PAT-one

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.

Sponsors

Johns Hopkins University
CollaboratorOTHER
University of Colorado, Denver
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 36 Years
Healthy volunteers
Yes

Inclusion criteria

pregnant, age 18-35, possession of, or availablitiy of using a cell phone. \-

Exclusion criteria

for the control group the following are

Design outcomes

Primary

MeasureTime frameDescription
Apnea-Hypopnea index 4%in a single full night recordingnumber of apneas and hypopneas dropping oxygen saturation 4%, per hour

Other

MeasureTime frameDescription
Central Apnea-Hypopnea Index 4%in a single full night recordingnumber of central apnea or hypopnea events dropping oxygen saturation 4%, per hour
Central Apnea Hypopnea Index 3%in a single full night recordingnumber of centrap apnea or hypopnea events dropping oxygen saturation 3%, per hour
Mean Oxygen Saturation during sleepaveraged through one full night recordingthe average oxygen saturation
Lowest oxygen saturation during sleepduring one full night recordingthe single lowest oxygen saturation measured
Apnea-Hypopnea Index 3%in a single full night recordingnumber of apneas and hypopneas dropping oxygen saturation 3%, per hour
Time (in minutes) with oxygen saturation below 85%during one full night recordingas above
percentage of babies small for gestational agemeasurements made at birth. Correlations will be determined at completion of research studylength weight and gestational age will be considered for each baby, to determine if it is small for gestational age. comparison will be made between cohorts. But also, analysis to determine is AHI correlated with small for gestational age
Apgar at 1 minuteMeasurement, 1 minute after birth. Correlations will be determined at completion of research study.This will be looked at for correlation with the AHI, along with the usual comparison between cohorts
Apgar at 5 minutesMeasurement, 5 minutes after birth. Correlations will be determined at completion of research studyThis will be looked at for correlation with the AHI, along with the usual comparison between cohorts.
Time (in minutes) with oxygen saturation below 89%during one full night recordingas above

Contacts

Primary ContactDAVID S PATZ, MD
david.patz@cuanschutz.edu9706407240

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026