RecruitingNot Applicable

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

Israel50 participantsStarted 2026-01-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is studying how fluid buildup in the body affects sleep apnea in heart failure patients — does my current level of fluid retention make me a reasonable candidate to discuss with the research team?
2Since this study is measuring changes in the apnea-hypopnea index, what does my current AHI score look like, and how would tracking that number help or change how you manage both my heart failure and my sleep apnea?
3This trial is listed as 'Phase NA,' which often means it's an observational or mechanistic study rather than one testing a new treatment — does that mean there's no experimental intervention involved, and what would actually be expected of me if I participated?
4If the goal is to understand the relationship between volume overload and sleep apnea, could optimizing my heart failure medications to reduce fluid retention already improve my sleep apnea on its own, without me joining a study?
5How would participating in this trial fit into my existing care routine — would it require extra sleep studies, hospital visits, or monitoring that might be difficult to manage alongside my current heart failure treatment?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in apnea-hypopnea index (AHI)

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

Trial details

NCT IDNCT07601724

SponsorItshak Amsalem

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-01

Contact for this trial

Itshak Amsalem, MD

+972508229454 itshak1a@gmail.com

View on ClinicalTrials.gov More Heart Failure trials