OSA-CHTN: OSA in Pregnant Women With Chronic HTN

Sponsor

Duke University (Other)

Overall Status

Completed

CT.gov ID

NCT03230110

Collaborator

Society for Obstetric Anesthesia and Perinatology (Other)

100

Enrollment

Locations

22.4

Actual Duration (Months)

Patients Per Site

2.2

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Sleep Apnea, Obstructive Pregnancy Hypertension	Diagnostic Test: WP200U home sleep study device

Study Design

Study Type:

Observational

Actual Enrollment :

100 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Obstructive Sleep Apnea Among Pregnant Women With Chronic Hypertension

Actual Study Start Date :

Jun 16, 2017

Actual Primary Completion Date :

Apr 30, 2019

Actual Study Completion Date :

Apr 30, 2019

Arms and Interventions

Arm	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

Arm

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

Other Names:

WatchPAT

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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.