Heart FailureNCT07601724
The Impact of Volume Overload on Obstructive Sleep Apnea in Patients With Congestive Heart Failure
An observational study of Heart Failure and Obstructive Sleep Apnea (OSA), run by Itshak Amsalem at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Obstructive Sleep Apnea (OSA)
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jan 2026to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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:
Read more
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)
- Medical subject headings
- Heart Failure, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Change in oxygen desaturation index (ODI) measured by the WatchPAT device between pre-diuresis and post-diuresis assessments
Measured: From first night of hospitalization to achievement of clinical euvolemia, up to 30-days.
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
Measured: 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
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
Measured: 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
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
Measured: From first night of hospitalization to achievement of clinical euvolemia, up to 30 days
Change in neck circumference
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
Measured: 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)
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
Measured: From admission to achievement of clinical euvolemia, up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start1 Jan 2026
- Primary completionJan 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Itshak Amsalem
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Itshak Amsalem, Shaare Zedek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07601724
- Sponsor's protocol ID
- 0350-24-SZMC
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2026
- Last updated
- 22 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data (IPD) sharing is currently undecided. Any future data sharing will depend on institutional policies, ethical approvals, and applicable data protection regulations. If shared, only de-identified data will be made available to qualified researchers upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Volume Overload on Obstructive Sleep Apnea in Patients With Congestive Heart Failure
- ClinicalTrials.gov ID
- NCT07601724
- Acronym / sponsor ID
- 0350-24-SZMC
- Conditions
- Heart Failure, Obstructive Sleep Apnea (OSA)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Itshak AmsalemUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: Undecided. Individual participant data (IPD) sharing is currently undecided. Any future data sharing will depend on institutional policies, ethical approvals, and applicable data protection regulations. If shared, only de-identified data will be made available to qualified researchers upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Obstructive Sleep Apnea (OSA), run by Itshak Amsalem at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Itshak Amsalem, MD (+972508229454, itshak1a@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in apnea-hypopnea index (AHI) (time frame: From first night of hospitalization to achievement of clinical euvolemia (during hospitalization), up to 30-days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.