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

19 maj 2026 uppdaterad av: 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.

Studieöversikt

Status

Rekrytering

Betingelser

Studietyp

Observationell

Inskrivning (Beräknad)

50

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in apnea-hypopnea index (AHI)
Tidsram: 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.

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in oxygen desaturation index (ODI)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Itshak Amsalem

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 januari 2026

Primärt slutförande (Beräknad)

1 januari 2027

Avslutad studie (Beräknad)

1 juni 2027

Studieregistreringsdatum

Först inskickad

15 april 2026

Först inskickad som uppfyllde QC-kriterierna

19 maj 2026

Första postat (Faktisk)

22 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

22 maj 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

19 maj 2026

Senast verifierad

1 april 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 0350-24-SZMC

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

OBESLUTSAM

IPD-planbeskrivning

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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