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

NCT ID: NCT06702475

Last Updated: 2024-11-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2026-12-01

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.

Conditions

Pre-Eclampsia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Home Sleep Test with Watch PAT-one

Intervention Type: 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.

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.

Home Sleep Test with Watch PAT-one

Intervention Type: 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.

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.

Home Sleep Test with Watch PAT-one

Intervention Type: 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.

Interventions

Home 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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

-

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 36 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

David Patz

Senior Clinical Instructior, Pulmonary Medicine.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cynthia Argani, MD

Role: STUDY_CHAIR

Johns Hopkins Hospital OB-GYN

Central Contacts

DAVID S PATZ, MD

Role: CONTACT

david.patz@cuanschutz.edu

9706407240

Other Identifiers

23-1743

Identifier Type: -

Identifier Source: org_study_id