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NCT Number: NCT03230110

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 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

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Key information

Conditions

Sleep Apnea, Obstructive Apnea Cardiovascular Diseases Dyssomnias Hypertension Nervous System Diseases Pregnancy Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders Vascular Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Duke Hospital, Durham, North Carolina, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: WatchPAT

Primary outcomes

  1. Prevalence of OSA in pregnant women with chronic HTN

    Time frame: 20 months

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

    Time frame: 20 months

Secondary outcomes

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

    Time frame: 20 months

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

    Time frame: 20 months

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

    Time frame: 20 months

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

    Time frame: 20 months

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Society for Obstetric Anesthesia and Perinatology

Registry information

Official study title

Obstructive Sleep Apnea Among Pregnant Women With Chronic Hypertension

Acronym: OSA-CHTN

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 26, 2017
Registry last updated
Sep 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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