Heart Failure, Obstructive Sleep Apnea (OSA)
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Itshak Amsalem
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in apnea-hypopnea index (AHI) | From first night of hospitalization to achievement of clinical euvolemia (during hospitalization), up to 30-days. | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in oxygen desaturation index (ODI) | From first night of hospitalization to achievement of clinical euvolemia, up to 30-days. | Change in oxygen desaturation index (ODI) measured by the WatchPAT device between pre-diuresis and post-diuresis assessments |
| Change in respiratory disturbance index (RDI) | From first night of hospitalization to achievement of clinical euvolemia, up to 30-days. | 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 |
| Correlation between change in respiratory disturbance index (RDI) and body weight change | From first night of hospitalization to achievement of clinical euvolemia, up to 30-days. | 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 |
| Correlation between change in apnea-hypopnea index (AHI) and body weight change | From first night of hospitalization to achievement of clinical euvolemia, up to 30 days | 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 |
| Change in neck circumference | From admission to achievement of clinical euvolemia, up to 30 days | 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 |
| Correlation coefficient between change in neck circumference and change in apnea-hypopnea index (AHI) | From admission to achievement of clinical euvolemia, up to 30 days | 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 |
Countries
Israel
Contacts
CONTACTItshak Amsalem, MD
Outcome results
None listed