Hypertension, Pregnancy, Sleep Apnea, Obstructive
Conditions
Keywords
Sleep disordered breathing, Obstructive sleep apnea, Hypertension, Pregnancy
Brief summary
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
Interventions
DIAGNOSTIC_TESTWP200U 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.
Sponsors
Society for Obstetric Anesthesia and Perinatology
Duke University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| 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
| 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 |
Countries
United States
Outcome results
None listed