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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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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| Measure | Description | Time Frame |
|---|---|---|
| Change in apnea-hypopnea index (AHI) | 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 | From first night of hospitalization to achievement of clinical euvolemia (during hospitalization), up to 30-days. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in oxygen desaturation index (ODI) | Change in oxygen desaturation index (ODI) measured by the WatchPAT device between pre-diuresis and post-diuresis assessments | From first night of hospitalization to achievement of clinical euvolemia, up to 30-days. |
| Change in respiratory disturbance index (RDI) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Itshak Amsalem, MD | Contact | +972508229454 | itshak1a@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shaare Zedek Medical Center | Recruiting | Jerusalem | Israel |
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.
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
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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 |
| From first night of hospitalization to achievement of clinical euvolemia, up to 30-days. |
| Correlation between change in respiratory disturbance index (RDI) and body weight change | 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 | From first night of hospitalization to achievement of clinical euvolemia, up to 30-days. |
| Correlation between change in apnea-hypopnea index (AHI) and body weight change | 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 | From first night of hospitalization to achievement of clinical euvolemia, up to 30 days |
| Change in neck circumference | 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 | From admission to achievement of clinical euvolemia, up to 30 days |
| Correlation coefficient between change in neck circumference and change in apnea-hypopnea index (AHI) | 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 | From admission to achievement of clinical euvolemia, up to 30 days |
| D012120 |
| Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |