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NCT Number: NCT07601724

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

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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Key information

Conditions

Heart Failure Apnea Cardiovascular Diseases Dyssomnias Heart Diseases Nervous System Diseases Obstructive Sleep Apnea (OSA) Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Shaare Zedek Medical Center

Jerusalem, Israel

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change in apnea-hypopnea index (AHI)

    Time frame: 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 outcomes

  1. Change in oxygen desaturation index (ODI)

    Time frame: 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

  2. Change in respiratory disturbance index (RDI)

    Time frame: 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

  3. Correlation between change in respiratory disturbance index (RDI) and body weight change

    Time frame: 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

  4. Correlation between change in apnea-hypopnea index (AHI) and body weight change

    Time frame: 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

  5. Change in neck circumference

    Time frame: 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

  6. Correlation coefficient between change in neck circumference and change in apnea-hypopnea index (AHI)

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Itshak Amsalem, MD

CONTACT

[email protected]

+972508229454

Sponsors and collaborators

Lead sponsor

Itshak Amsalem

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 22, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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