The Impact of Volume Overload on Obstructive Sleep Apnea in Patients With Congestive Heart Failure

NCT07601724 | Recruiting

• 1 other identifier: 0350-24-SZMC
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Obstructive Sleep Apnea (OSA)

Outcome Measures

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

  From first night of hospitalization to achievement of clinical euvolemia (during hospitalization), up to 30-days.

Secondary Outcomes (6)

• Change in oxygen desaturation index (ODI)

  From first night of hospitalization to achievement of clinical euvolemia, up to 30-days.

• Change in respiratory disturbance index (RDI)

  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

  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

  From first night of hospitalization to achievement of clinical euvolemia, up to 30 days

• Change in neck circumference

  From admission to achievement of clinical euvolemia, up to 30 days

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Itshak Amsalem: lead

Study Sites (1)

Shaare Zedek Medical Center

Jerusalem, Israel

RECRUITING

MeSH Terms

Conditions

Heart Failure; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Central Study Contacts

Itshak Amsalem, MD

CONTACT

+972508229454; itshak1a@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: May 22, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-04

Locations

IL (1)