OSA in Pregnant Women With Chronic HTN (OSA-CHTN)

Obstructive Sleep Apnea Among Pregnant Women With Chronic Hypertension

The purpose of this study is to identify whether pregnant women with chronic hypertension are at significantly higher risk of having undiagnosed OSA and should be routinely screened with home sleep tests. The investigators will recruit 120 pregnant subjects between 10-20 weeks gestation from the Duke High Risk Obstetrics Clinic over a 20-month period. They will be enrolled into one of two groups: 1) chronic hypertension (on medication or hypertensive blood pressures documented at 3 clinic visits); 2) normal blood pressure, and not on any treatment for chronic HTN and no history of chronic HTN, and matched for BMI (+/- 3 kg/m2) with the chronic HTN group. The two groups will be matched for BMI to control for the effect of obesity on OSA diagnosis and cHTN. The primary hypothesis, that OSA prevalence differs between patients with chronic HTN and normotensive controls, will be assessed with a two-group two-sided Fisher's exact test. A Fisher's exact test with a 0.05 two-sided significance level will have 92% power to detect the difference between a normotensive OSA rate of 0.10 and a chronic hypertensive OSA rate of 0.40 when the sample size in each group is 50. There are no risks associated with the use of the home sleep test device, but subjects that have a severe latex allergy should not participate, as the device

Study Overview

• Status: Completed
• Conditions: Sleep Apnea, Obstructive; Hypertension; Pregnancy
• Intervention / Treatment: Diagnostic test: WP200U home sleep study device

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
    • Durham, North Carolina, United States, 27710
      • Duke Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

The investigators will recruit 120 adult pregnant subjects between 10-20 weeks gestation from Duke Hospital and clinics in Durham, NC over a 20-month period. They will be enrolled into one of two groups: 1) chronic hypertension (on medication or hypertensive blood pressures documented on two clinic visits); 2) normal blood pressure, and not on any treatment for chronic HTN and no history of chronic HTN, and matched for BMI (+/- 3 kg/m2) with the chronic HTN group. The two groups will be matched for BMI to control for the effect of obesity on OSA diagnosis and cHTN.

Description

Inclusion Criteria:

• Pregnant woman who are patients of:Duke Hospital, Duke Birthing Center (DBC), Duke Perinatal Durham clinic, Inpatients will be recruited from the obstetric antepartum service.
• Gestational age 10 weeks, 0 days to 20 weeks, 6 days
• 18 years or older
• English speaking
• They will be enrolled into one of two groups:-Chronic hypertension (on medication or hypertensive blood pressures documented on two clinic visits (including prior to pregnancy), -Normal blood pressure, and not on any treatment for chronic HTN and no history of chronic HTN, and matched for BMI (+/- 3 kg/m2) with the chronic HTN group
• The two groups will be matched for body mass index to control for the effect of obesity on OSA diagnosis and HTN.
• Subjects will be not be excluded if they have an established diagnosis of OSA that is not currently being treated.

Exclusion Criteria:

• Being treated for OSA
• On chronic opioids
• On alpha-blockers (which can interfere with the PAT signal)
• Have secondary HTN
• Unwilling to remove nail polish and/or shorten one nail (which can also interfere with the PAT signal)
• Have a severe allergy to latex
• Do not speak English.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Chronic Hypretension in Pregnancy; Pregnant subjects between 10-20 weeks gestation with chronic hypertension (on medication or hypertensive blood pressures documented at 2 clinic visits)	Diagnostic test: WP200U home sleep study device; WP200U, is a Type III, wrist-worn, FDA-approved home sleep testing device that utilizes finger plethysmography (peripheral arterial tone, oxyhemoglobin saturation and heart rate), actigraphy (movement), acoustic decibel detection (snoring volume), and accelerometry (body position) to help diagnose sleep-related breathing disorders (including snoring), and to give information about sleep stages and position during actual sleep time.; Other Names: WatchPAT
Normotensive in Pregnancy; Pregnant subjects between 10-20 weeks gestation with normal blood pressure, and not on any treatment for chronic hypertension and no history of chronic hypertension, and matched for body mass index (+/- 3 kg/m2) with the chronic hypertension group.	Diagnostic test: WP200U home sleep study device; WP200U, is a Type III, wrist-worn, FDA-approved home sleep testing device that utilizes finger plethysmography (peripheral arterial tone, oxyhemoglobin saturation and heart rate), actigraphy (movement), acoustic decibel detection (snoring volume), and accelerometry (body position) to help diagnose sleep-related breathing disorders (including snoring), and to give information about sleep stages and position during actual sleep time.; Other Names: WatchPAT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Prevalence of OSA in pregnant women with chronic HTN	20 months
Prevalence of OSA in pregnant women who are normotensive and BMI-matched to women with chronic HTN	20 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Apnea-hypopnea indices in pregnant women with untreated OSA and cHTN	20 months
Apnea-hypopnea indices in pregnant women with untreated OSA and normotensive.	20 months
Oxygen-desaturation indices in pregnant women with untreated OSA and cHTN	20 months
Oxygen-desaturation indices in pregnant women with untreated OSA and normotensive.	20 months

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Society for Obstetric Anesthesia and Perinatology
• Investigators: Principal Investigator: Jennifer Dominguez, MD, MHS, Duke University Medical Center, Dept Anesthesiology

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2017
• Primary Completion (Actual): April 30, 2019
• Study Completion (Actual): April 30, 2019

Study Registration Dates

• First Submitted: July 24, 2017
• First Submitted That Met QC Criteria: July 24, 2017
• First Posted (Actual): July 26, 2017

Study Record Updates

• Last Update Posted (Actual): September 24, 2019
• Last Update Submitted That Met QC Criteria: September 20, 2019
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Hypertension; Obstructive sleep apnea; Pregnancy; Sleep disordered breathing
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Hypertension; Apnea
• Other Study ID Numbers: Pro00081272

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No