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临床试验/NCT03230110
NCT03230110已完成不适用

Obstructive Sleep Apnea Among Pregnant Women With Chronic Hypertension

Duke University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年6月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
Prevalence of OSA in pregnant women who are normotensive and BMI-matched to women with chronic HTN

研究概览

简要总结

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

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

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

时间窗: 20 months

Prevalence of OSA in pregnant women with chronic HTN

时间窗: 20 months

次要结局

  • 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)
  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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