The Impact of Volume Overload on Obstructive Sleep Apnea in Patients With Congestive Heart Failure
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorItshak Amsalem
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
50 Participants
are grouped into 1 trial groupGroup A: Adults With Heart Failure Undergoing Diuresis
Trial outcomes
Primary outcomes
1
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
Time frame
From first night of hospitalization to achievement of clinical euvolemia (during hospitalization), up to 30-days.Secondary outcomes
1
Change in oxygen desaturation index (ODI)
Change in oxygen desaturation index (ODI) measured by the WatchPAT device between pre-diuresis and post-diuresis assessments
Time frame
From first night of hospitalization to achievement of clinical euvolemia, up to 30-days.2
Change in respiratory disturbance index (RDI)
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
Time frame
From first night of hospitalization to achievement of clinical euvolemia, up to 30-days.3
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
Time frame
From first night of hospitalization to achievement of clinical euvolemia, up to 30-days.4
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
Time frame
From first night of hospitalization to achievement of clinical euvolemia, up to 30 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Itshak Amsalem
Lead sponsor
Shaare Zedek Medical Center
Sponsor institution
Source ClinicalTrials.gov