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Targeted CPAP Therapy for Obstructive Sleep Apnea in Pregnancy

2019年11月25日 更新者：CAPT Dennis Spence, NC, USN, PhD, CRNA、United States Naval Medical Center, San Diego

Randomized Controlled Trial for a Sleep Study and Targeted CPAP Therapy for Obstructive Sleep Apnea to Reduce the Incidence Adverse Pregnancy Related Outcomes

Prospective, randomized controlled trial. Pregnant women in early pregnancy will be randomized to either the Sleep Study + CPAP (Continuous Positive Airway Pressure Therapy) group or to a Standard Prenatal Care group. Subjects in the Sleep Study + CPAP group will complete a sleep study (WatchPAT-200, Itamar Medical, Inc.) and have CPAP initiated if the Apnea Hypopnea Index (AHI) ≥5 as indicated, in early and late pregnancy, whereas the other group will receive standard prenatal care. All subjects will complete a sleep study again between 8 to 12 weeks postpartum.

研究概览

地位

完全的

条件

干预/治疗

详细说明

Objective/Hypothesis: The purpose of this study is to determine if parturients identified as high risk for obstructive sleep apnea (OSA; defined as an apnea hypopnea index [AHI] ≥5 events/hour) who are randomized to receive an unattended sleep study during early and late pregnancy (early = between 6 and 16 weeks; late = between 27 and 33 weeks) plus initiation of CPAP therapy if the AHI ≥5 events/hour and standard prenatal care have a decreased incidence of adverse pregnancy outcomes (defined as a composite variable which includes gestational hypertension, preeclampsia, eclampsia, gestational diabetes, preterm birth, low birth weight, or stillbirth) at the time of delivery when compared to a group who receives standard prenatal care only (no sleep study and CPAP initiation). At 8 to 12 months postpartum subjects in both groups will complete a sleep study.

研究类型

介入性

注册 (实际的)

193

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • California
      • San Diego、California、美国、92134
        • Naval Medical Center

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

女性

描述

Inclusion Criteria

  1. At least one of the following risk factors for OSA: prepregnancy BMI ≥ 30kg/m2, chronic hypertension, pregestational diabetes, twin gestation, or a history of prior pregnancy affected by: preeclampsia, eclampsia or fetal growth restriction.
  2. Between 6 and 16 weeks gestation at time of enrollment.

Exclusion Criteria

  1. Current diagnosis and treatment of OSA.
  2. Patient refusal to randomization.
  3. Permanent Pacemaker (interfere with WATCHPAT sleep study).
  4. Currently taking alpha blockers or nitrates (interfere with WATCHPAT sleep study).
  5. Coronary artery disease or congestive heart failure or cardiomyopathy.
  6. Not delivering and completing their postpartum visit at Naval Medical Center San Diego (NMCSD).
  7. Inability to read or understand the consent.
  8. <18 years of age.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Sleep Study + CPAP group
Pregnant women in early pregnancy may be randomized to this arm and be assigned Sleep study + CPAP treatment
设备：CPAP
Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea
其他：Standard Prenatal Care group
Pregnant women in early pregnancy may be randomized to this arm and will receive standard prenatal care without CPAP treatment.
其他：Pre-natal care
Standard Pre-Natal Care

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Number of Participants With Adverse Pregnancy Outcomes
大体时间：time of delivery
Number of participants with adverse pregnancy outcomes (composite outcome includes: gestational hypertension, preeclampsia, eclampsia, gestational diabetes, preterm delivery, low birth weight, or stillbirth)
time of delivery

次要结果测量

结果测量
措施说明
大体时间
Incidence of Obstructive Sleep Apnea (OSA) in Early Pregnancy - Treatment Group Only (6-16 Weeks)
大体时间：early pregnancy (6-16 weeks)
Incidence of OSA severity in early pregnancy (6-16 weeks) in treatment group only. Data were not collected for Control group at this time point.
early pregnancy (6-16 weeks)
Incidence of OSA in Late Pregnancy- Treatment Group Only (27-33 Weeks)
大体时间：27-33 weeks
Incidence and severity of OSA in late pregnancy- treatment group only (27-33 weeks). Data were not collected for Control group at this time point
27-33 weeks
Incidence of OSA at 8 to 12 Weeks Postpartum in Treatment and Control Group
大体时间：8-12 weeks postpartum
Incidence and severity of OSA at 8 to 12 weeks postpartum in treatment and control group.
8-12 weeks postpartum
Hospital Costs at Time of Delivery
大体时间：Hospital costs at time of delivery
Hospital costs at time of delivery in treatment and control group.
Hospital costs at time of delivery

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

United States Naval Medical Center, San Diego

调查人员

  • 研究主任：Dennis L Spence, PhD、United States Naval Medical Center, San Diego

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2017年2月20日

初级完成 (实际的)

2019年10月14日

研究完成 (实际的)

2019年10月14日

研究注册日期

首次提交

2016年3月11日

首先提交符合 QC 标准的

2016年4月27日

首次发布 (估计)

2016年4月29日

研究记录更新

最后更新发布 (实际的)

2019年11月27日

上次提交的符合 QC 标准的更新

2019年11月25日

最后验证

2019年11月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • NMCSD.2016.0029

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

Plan to submit manuscripts to appropriate journals and present data at appropriate conferences

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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