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Recruiting NCT07601724

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

— Observational Heart Failure Obstructive Sleep Apnea (OSA)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Heart Failure, Obstructive Sleep Apnea (OSA). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Israel
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Primary outcome measures

  • Change in apnea-hypopnea index (AHI) [Time frame: From first night of hospitalization to achievement of clinical euvolemia (during hospitalization), up to 30-days.]
Secondary outcome measures (6)
  • Change in oxygen desaturation index (ODI) [Time frame: From first night of hospitalization to achievement of clinical euvolemia, up to 30-days.]
  • Change in respiratory disturbance index (RDI) [Time frame: 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 [Time frame: 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 [Time frame: From first night of hospitalization to achievement of clinical euvolemia, up to 30 days]
  • Change in neck circumference [Time frame: 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) [Time frame: From admission to achievement of clinical euvolemia, up to 30 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Israel · 1 center
  • Shaare Zedek Medical Center — Jerusalem

Identifiers

NCT: NCT07601724 · 0350-24-SZMC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗