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

NCT06702475 | Not Yet Recruiting

• 1 other identifier: 23-1743
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pre-Eclampsia

Keywords

Pre-Eclampsia, Altitude, Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Apnea-Hypopnea index 4%

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

  in a single full night recording

Other Outcomes (10)

• Apnea-Hypopnea Index 3%

  in a single full night recording

• Central Apnea-Hypopnea Index 4%

  in a single full night recording

• Central Apnea Hypopnea Index 3%

  in a single full night recording

Study Arms (3)

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

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.

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.

Diagnostic Test: Home Sleep Test with Watch PAT-one

Interventions

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.

healthy pregnant women at altitude (Cohort 2); healthy pregnant women at sea level (Cohort 3); pregnant with pre-eclampsia at altitude (Cohort 1)

Eligibility Criteria

• Age: 18 Years - 36 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

pregnant women, age 15-35, some who are healthy, and some who have developed preeclampsia.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Johns Hopkins University: collaborator

MeSH Terms

Conditions

Pre-Eclampsia; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

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

Study Officials

• Cynthia Argani, MD

  Johns Hopkins Hospital OB-GYN

  STUDY CHAIR

Central Study Contacts

DAVID S PATZ, MD

CONTACT

9706407240; david.patz@cuanschutz.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Clinical Instructior, Pulmonary Medicine.

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: November 25, 2024
• Study Start: April 1, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 25, 2024

Record last verified: 2024-11