OSA in Pregnant Women With Chronic HTN

NCT03230110 | Completed

• 1 other identifier: Pro00081272
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Sleep Apnea, Obstructive; Pregnancy; Hypertension

Keywords

Sleep disordered breathing; Obstructive sleep apnea; Hypertension; Pregnancy

Outcome Measures

Primary Outcomes (2)

• Prevalence of OSA in pregnant women with chronic HTN

  20 months

• Prevalence of OSA in pregnant women who are normotensive and BMI-matched to women with chronic HTN

  20 months

Secondary Outcomes (4)

• Apnea-hypopnea indices in pregnant women with untreated OSA and cHTN

  20 months

• Apnea-hypopnea indices in pregnant women with untreated OSA and normotensive.

  20 months

• Oxygen-desaturation indices in pregnant women with untreated OSA and cHTN

  20 months

• Oxygen-desaturation indices in pregnant women with untreated OSA and normotensive.

  20 months

Study Arms (2)

Chronic Hypretension in Pregnancy

Pregnant subjects between 10-20 weeks gestation with chronic hypertension (on medication or hypertensive blood pressures documented at 2 clinic visits)

Diagnostic Test: WP200U home sleep study device

Normotensive in Pregnancy

Pregnant subjects between 10-20 weeks gestation with normal blood pressure, and not on any treatment for chronic hypertension and no history of chronic hypertension, and matched for body mass index (+/- 3 kg/m2) with the chronic hypertension group.

Diagnostic Test: WP200U home sleep study device

Interventions

WP200U home sleep study device DIAGNOSTIC_TEST

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.

Also known as: WatchPAT

Chronic Hypretension in Pregnancy; Normotensive in Pregnancy

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Limited to pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The investigators will recruit 120 adult pregnant subjects between 10-20 weeks gestation from Duke Hospital and clinics in Durham, NC over a 20-month period. They will be enrolled into one of two groups: 1) chronic hypertension (on medication or hypertensive blood pressures documented on two 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.

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
• 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.

Sponsors & Collaborators

• Duke University: lead
• Society for Obstetric Anesthesia and Perinatology: collaborator

Study Sites (2)

Duke Hospital

Durham, North Carolina, 27710, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

• Dominguez JE, Grotegut CA, Wright MC, Habib AS. Obstructive Sleep Apnea Among Gravidas With Chronic Hypertension Compared to Matched Controls: A Prospective Cohort Study. Anesth Analg. 2023 Feb 1;136(2):205-214. doi: 10.1213/ANE.0000000000006223. Epub 2022 Nov 10.

  PMID: 36355613 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Serum

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Hypertension; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jennifer Dominguez, MD, MHS

  Duke University Medical Center, Dept Anesthesiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2017
• First Posted: July 26, 2017
• Study Start: June 16, 2017
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2019
• Last Updated: September 24, 2019

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)