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

19. maj 2026 opdateret af: Itshak Amsalem

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.

Studieoversigt

Status

Rekruttering

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Anslået)

50

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Israel
      • Jerusalem, Israel
        • Rekruttering
        • Shaare Zedek Medical Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in apnea-hypopnea index (AHI)
Tidsramme: 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
From first night of hospitalization to achievement of clinical euvolemia (during hospitalization), up to 30-days.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in oxygen desaturation index (ODI)
Tidsramme: 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
From first night of hospitalization to achievement of clinical euvolemia, up to 30-days.
Change in respiratory disturbance index (RDI)
Tidsramme: 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
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
Tidsramme: 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
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
Tidsramme: 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
From first night of hospitalization to achievement of clinical euvolemia, up to 30 days
Change in neck circumference
Tidsramme: 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
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)
Tidsramme: 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
From admission to achievement of clinical euvolemia, up to 30 days

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Itshak Amsalem

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. januar 2026

Primær færdiggørelse (Anslået)

1. januar 2027

Studieafslutning (Anslået)

1. juni 2027

Datoer for studieregistrering

Først indsendt

15. april 2026

Først indsendt, der opfyldte QC-kriterier

19. maj 2026

Først opslået (Faktiske)

22. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. maj 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 0350-24-SZMC

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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