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NCT Number: NCT06702475

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

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.

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Key information

Conditions

Pre-eclampsia Apnea Dyssomnias Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Nervous System Diseases Pregnancy Complications Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders Urogenital Diseases

Age range

18 year–36 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

Home Sleep Test with Watch PAT-one

Diagnostic 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.

Primary outcomes

  1. Apnea-Hypopnea index 4%

    Time frame: in a single full night recording

    number of apneas and hypopneas dropping oxygen saturation 4%, per hour

Other outcomes

  1. Apnea-Hypopnea Index 3%

    Time frame: in a single full night recording

    number of apneas and hypopneas dropping oxygen saturation 3%, per hour

  2. Central Apnea-Hypopnea Index 4%

    Time frame: in a single full night recording

    number of central apnea or hypopnea events dropping oxygen saturation 4%, per hour

  3. Central Apnea Hypopnea Index 3%

    Time frame: in a single full night recording

    number of centrap apnea or hypopnea events dropping oxygen saturation 3%, per hour

  4. Mean Oxygen Saturation during sleep

    Time frame: averaged through one full night recording

    the average oxygen saturation

  5. Lowest oxygen saturation during sleep

    Time frame: during one full night recording

    the single lowest oxygen saturation measured

  6. Time (in minutes) with oxygen saturation below 89%

    Time frame: during one full night recording

    as above

  7. Time (in minutes) with oxygen saturation below 85%

    Time frame: during one full night recording

    as above

  8. percentage of babies small for gestational age

    Time frame: measurements made at birth. Correlations will be determined at completion of research study

    length 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"

  9. Apgar at 1 minute

    Time frame: Measurement, 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

  10. Apgar at 5 minutes

    Time frame: Measurement, 5 minutes 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.

Study contacts

Contact information is provided by the study sponsor or research team.

DAVID S PATZ, MD

CONTACT

[email protected]

9706407240

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Johns Hopkins University

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 25, 2024
Registry last updated
Nov 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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