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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
193
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
California
-
San Diego、California、アメリカ、92134
- Naval Medical Center
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
女性
説明
Inclusion Criteria
- 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.
- Between 6 and 16 weeks gestation at time of enrollment.
Exclusion Criteria
- Current diagnosis and treatment of OSA.
- Patient refusal to randomization.
- Permanent Pacemaker (interfere with WATCHPAT sleep study).
- Currently taking alpha blockers or nitrates (interfere with WATCHPAT sleep study).
- Coronary artery disease or congestive heart failure or cardiomyopathy.
- Not delivering and completing their postpartum visit at Naval Medical Center San Diego (NMCSD).
- Inability to read or understand the consent.
- <18 years of age.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Sleep Study + CPAP group
Pregnant women in early pregnancy may be randomized to this arm and be assigned Sleep study + CPAP treatment
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Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea
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他の：Standard Prenatal Care group
Pregnant women in early pregnancy may be randomized to this arm and will receive standard prenatal care without CPAP treatment.
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Standard Pre-Natal Care
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Participants With Adverse Pregnancy Outcomes
時間枠：time of delivery
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Number of participants with adverse pregnancy outcomes (composite outcome includes: gestational hypertension, preeclampsia, eclampsia, gestational diabetes, preterm delivery, low birth weight, or stillbirth)
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time of delivery
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Incidence of Obstructive Sleep Apnea (OSA) in Early Pregnancy - Treatment Group Only (6-16 Weeks)
時間枠：early pregnancy (6-16 weeks)
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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.
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early pregnancy (6-16 weeks)
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Incidence of OSA in Late Pregnancy- Treatment Group Only (27-33 Weeks)
時間枠：27-33 weeks
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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
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27-33 weeks
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Incidence of OSA at 8 to 12 Weeks Postpartum in Treatment and Control Group
時間枠：8-12 weeks postpartum
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Incidence and severity of OSA at 8 to 12 weeks postpartum in treatment and control group.
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8-12 weeks postpartum
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Hospital Costs at Time of Delivery
時間枠：Hospital costs at time of delivery
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Hospital costs at time of delivery in treatment and control group.
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Hospital costs at time of delivery
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- スタディディレクター：Dennis L Spence, PhD、United States Naval Medical Center, San Diego
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2017年2月20日
一次修了 (実際)
2019年10月14日
研究の完了 (実際)
2019年10月14日
試験登録日
最初に提出
2016年3月11日
QC基準を満たした最初の提出物
2016年4月27日
最初の投稿 (見積もり)
2016年4月29日
学習記録の更新
投稿された最後の更新 (実際)
2019年11月27日
QC基準を満たした最後の更新が送信されました
2019年11月25日
最終確認日
2019年11月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- NMCSD.2016.0029
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
Plan to submit manuscripts to appropriate journals and present data at appropriate conferences
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
はい
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