OSA in Pregnant Women With Chronic HTN
| Status: | Recruiting |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), Insomnia Sleep Studies, Women's Studies, Pulmonary, Pulmonary |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Psychiatry / Psychology, Pulmonary / Respiratory Diseases, Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/16/2018 |
| Start Date: | June 16, 2017 |
| End Date: | November 1, 2019 |
| Contact: | Jennifer Dominguez, MD, MHS |
| Email: | jennifer.dominguez@dm.duke.edu |
| Phone: | 919-668-2024 |
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
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
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.
We found this trial at
2
sites
2301 Erwin Rd
Durham, North Carolina 27710
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Jennifer E Dominguez, MD
Phone: 919-970-8230
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