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NCT03230110 · ClinicalTrials.gov registry record
OSA in Pregnant Women With Chronic HTN
A clinical trial, sponsored by Duke University.
- Completed
- Registry status
- 100
- Enrollment target
NCT03230110: Completed study, sponsored by Duke University.
NCT03230110 is a clinical trial that has completed, run by Duke University. The registered enrollment target is 100 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03230110 has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- 100 participants
- Enrollment target
Study 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_TEST WP200U home sleep study device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2017-06-16 |
| Est. Completion | 2019-04-30 |
What the finished NCT03230110 record still lists
NCT03230110 is an observational study that tracks outcomes without assigning an intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which WP200U home sleep study device is the first listed.
NCT03230110 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03230110 about?
NCT03230110 is a clinical study titled "OSA in Pregnant Women With Chronic HTN". 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 Duk...
What is the current status of trial NCT03230110?
This trial is currently completed. The enrollment target is 100 participants. The study started on 2017-06-16. Estimated completion is 2019-04-30.
What interventions are being tested in trial NCT03230110?
The interventions under investigation include: WP200U home sleep study device (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03230110?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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