OSA in Pregnant Women With Chronic HTN
Completed
Conditions studied: Sleep Apnea, Obstructive, Pregnancy, Hypertension
In brief
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
Key facts
- Study ID
- NCT03230110
- Run by
- Duke University
- People needed
- 100
- Starts
- 2017-06-16
- Expected to finish
- 2019-04-30
- Last updated by the study team
- 2019-09-24
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Duke Hospital — Durham, North Carolina, United States
- Duke University Medical Center — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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