The Impact of Volume Overload on Obstructive Sleep Apnea in Patients With Congestive Heart Failure
2026年5月19日 更新者：Itshak Amsalem
The goal of this observational study is to learn how removing extra fluid from the body (diuresis) affects sleep apnea in adults hospitalized with heart failure.
The main questions it aims to answer are:
Does sleep apnea severity improve after fluid removal? Is the improvement in sleep apnea related to the amount of fluid removed? Do changes in neck size reflect changes in sleep apnea severity?
Participants admitted to the hospital with heart failure and fluid overload will take part in this study.
Participants will:
Use a wearable sleep monitoring device (WatchPAT) on the first night of hospitalization Use the device again after fluid removal, when the treating cardiologist determines that the patient is no longer fluid overloaded Have their neck circumference measured before and after fluid removal Have their weight and fluid balance recorded during hospitalization Have routine blood tests and clinical assessments as part of standard care
Researchers will compare each participant's results before and after fluid removal to see if sleep apnea improves and whether these changes are linked to fluid removal and changes in neck circumference.
調査の概要
状態
募集
研究の種類
観察的
入学 (推定)
50
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。
研究連絡先
- 名前：Itshak Amsalem, MD
- 電話番号：+972508229454
- メール：itshak1a@gmail.com
研究場所
-
-
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Jerusalem、イスラエル
- 募集
- Shaare Zedek 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
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
サンプリング方法
非確率サンプル
調査対象母集団
Adults admitted with decompensated heart failure and clinical fluid overload, including both preserved and reduced ejection fraction.
Participants will be recruited during hospitalization in a dedicated heart failure unit and followed prospectively with sleep monitoring and clinical assessments before and after achievement of clinical euvolemia.
説明
Inclusion Criteria:
- Adults aged 18 years or older
- Hospitalized with decompensated heart failure and clinical evidence of fluid overload
- Diagnosis of heart failure (reduced or preserved ejection fraction)
- Clinically indicated for diuretic therapy
- Able to undergo sleep apnea assessment using the WatchPAT device
- Able to provide informed consent
Exclusion Criteria:
- Known central sleep apnea as the predominant sleep-disordered breathing type
- Current treatment with continuous positive airway pressure (CPAP)
- Acute respiratory failure requiring mechanical ventilation
- Conditions preventing proper use of the WatchPAT device (e.g., severe hand or finger injury)
- Hemodynamic instability precluding participation
- Pregnancy
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
コホートと介入
グループ/コホート |
|---|
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Adults With Heart Failure Undergoing Diuresis
Adults hospitalized with heart failure and fluid overload who undergo standard diuretic therapy.
Participants are evaluated using sleep monitoring (WatchPAT), neck circumference measurements, and clinical assessments before diuresis (on the first night of hospitalization) and after diuresis, when the treating cardiologist determines that the patient is no longer fluid overloaded.
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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 |
|---|---|---|
|
Change in apnea-hypopnea index (AHI)
時間枠：From first night of hospitalization to achievement of clinical euvolemia (during hospitalization), up to 30-days.
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Change in obstructive sleep apnea severity, measured by the apnea-hypopnea index (AHI) using the WatchPAT device, between the first night of hospitalization (pre-diuresis) and after diuresis, when the treating cardiologist determines that the participant is no longer fluid overloaded
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From first night of hospitalization to achievement of clinical euvolemia (during hospitalization), up to 30-days.
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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 |
|---|---|---|
|
Change in oxygen desaturation index (ODI)
時間枠：From first night of hospitalization to achievement of clinical euvolemia, up to 30-days.
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Change in oxygen desaturation index (ODI) measured by the WatchPAT device between pre-diuresis and post-diuresis assessments
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From first night of hospitalization to achievement of clinical euvolemia, up to 30-days.
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Change in respiratory disturbance index (RDI)
時間枠：From first night of hospitalization to achievement of clinical euvolemia, up to 30-days.
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Change in respiratory disturbance index (RDI), defined as the number of respiratory disturbance events per hour of sleep, measured using the WatchPAT device, between the first night of hospitalization (pre-diuresis) and after diuresis, when the treating cardiologist determines that the participant is no longer fluid overloaded
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From first night of hospitalization to achievement of clinical euvolemia, up to 30-days.
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Correlation between change in respiratory disturbance index (RDI) and body weight change
時間枠：From first night of hospitalization to achievement of clinical euvolemia, up to 30-days.
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Correlation between the change in respiratory disturbance index (RDI), measured in events per hour using the WatchPAT device, and change in body weight measured in kilograms during hospitalization
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From first night of hospitalization to achievement of clinical euvolemia, up to 30-days.
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Correlation between change in apnea-hypopnea index (AHI) and body weight change
時間枠：From first night of hospitalization to achievement of clinical euvolemia, up to 30 days
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Correlation between the change in apnea-hypopnea index (AHI), defined as the number of apnea and hypopnea events per hour of sleep and measured using the WatchPAT device, and change in body weight measured in kilograms during hospitalization
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From first night of hospitalization to achievement of clinical euvolemia, up to 30 days
|
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Change in neck circumference
時間枠：From admission to achievement of clinical euvolemia, up to 30 days
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Change in neck circumference, measured in centimeters using a standardized measuring tape, between pre-diuresis (at admission) and post-diuresis assessment after the treating cardiologist determines that the participant is no longer fluid overloaded
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From admission to achievement of clinical euvolemia, up to 30 days
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Correlation coefficient between change in neck circumference and change in apnea-hypopnea index (AHI)
時間枠：From admission to achievement of clinical euvolemia, up to 30 days
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Correlation coefficient (unitless) describing the relationship between change in neck circumference (centimeters) and change in apnea-hypopnea index (AHI), measured in events per hour using the WatchPAT device
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From admission to achievement of clinical euvolemia, up to 30 days
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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。
スポンサー
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)
2026年1月1日
一次修了 (推定)
2027年1月1日
研究の完了 (推定)
2027年6月1日
試験登録日
最初に提出
2026年4月15日
QC基準を満たした最初の提出物
2026年5月19日
最初の投稿 (実際)
2026年5月22日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月22日
QC基準を満たした最後の更新が送信されました
2026年5月19日
最終確認日
2026年4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
- 0350-24-SZMC
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?
未定
IPD プランの説明
Individual participant data (IPD) sharing is currently undecided.
Any future data sharing will depend on institutional policies, ethical approvals, and applicable data protection regulations.
If shared, only de-identified data will be made available to qualified researchers upon reasonable request.
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
いいえ
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