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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03230110
Other study ID # Pro00081272
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 16, 2017
Est. completion date April 30, 2019

Study information

Verified date October 2018
Source Duke University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date April 30, 2019
Est. primary completion date April 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

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.

Locations

Country Name City State
United States Duke Hospital Durham North Carolina
United States Duke University Medical Center Durham North Carolina

Sponsors (2)

Lead Sponsor Collaborator
Duke University Society for Obstetric Anesthesia and Perinatology

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence of OSA in pregnant women with chronic HTN 20 months
Primary Prevalence of OSA in pregnant women who are normotensive and BMI-matched to women with chronic HTN 20 months
Secondary Apnea-hypopnea indices in pregnant women with untreated OSA and cHTN 20 months
Secondary Apnea-hypopnea indices in pregnant women with untreated OSA and normotensive. 20 months
Secondary Oxygen-desaturation indices in pregnant women with untreated OSA and cHTN 20 months
Secondary Oxygen-desaturation indices in pregnant women with untreated OSA and normotensive. 20 months
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