OSA in Pregnant Women With Chronic HTN

Hypertension Clinical Trial

— OSA-CHTN  

Official title:

Obstructive Sleep Apnea Among Pregnant Women With Chronic Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03230110
• Other study ID #: Pro00081272
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Apnea
• Hypertension
• Pregnancy
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

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