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Artificial Voice Analysis and Telemonitoring for Heart Failure. A Feasibility Study (AVATAR-HF)

17 czerwca 2026 zaktualizowane przez: Niguarda Hospital

AVATAR-HF (Artificial Voice Analysis and Telemonitoring for Heart Failure): Studio di fattibilità Sull'Uso Dell'Analisi Vocale Basata su Intelligenza Artificiale Per il Telemonitoraggio Dei Pazienti Con Insufficienza Cardiaca.

Heart failure is a serious condition and a major reason why older adults are admitted to the hospital. Even after going home, many patients struggle to get the follow-up care they need, leading to high rates of return to the hospital.

While remote monitoring technology exists, it is often difficult to use, expensive, or hard for doctors to interpret.

Recent research suggests that changes in a person's voice and speech can be early warning signs of worsening heart failure, but we need to test if this can work reliably in a home setting.This study tests a new, user-friendly platform called AVATAR-SC.

This system uses a a computer-generated character to interact with patients. By analyzing short voice clips and simple health questionnaires provided by the patient, the system aims to make home monitoring easier and more effective.

The study will involve 60 participants divided into two groups:half of the patients who have recently been discharged from the hospital following a heart failure episode; the other 30 patients who visit the hospital monthly for a specific heart failure treatment (Levosimendan).

Participants will interact with the digital avatar twice a week. During these sessions, they will provide brief voice recordings and answer a few questions about how they feel. It is important to note that the AI in this study is not making medical decisions or changing the patient's current treatment; it is strictly being tested to see how well the technology functions.

As a feasibility study, the primary goal is to evaluate the practical implementation of the technology rather than clinical outcomes.

The research focuses on: Determining if patients can navigate the system easily and independently, Assessing how consistently participants engage with the scheduled sessions, Verifying the technical reliability of the platform in a home environment,identifying the strengths and challenges of the system to prepare for future, larger-scale trials.

Benefits: Participants may feel more supported and more aware of their symptoms through regular check-ins.

Risks: The risks are very low. They mostly involve getting used to new technology and ensuring that personal data is kept private and secure.

Impact If successful, AVATAR-SC could lead to a new way for doctors to keep an eye on heart failure patients at home, catching problems early through the sound of their voice and preventing unnecessary hospital visits.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

Heart Failure (HF) is a leading cause of hospitalization and mortality among the elderly, characterized by high readmission rates and a significant impact on the National Health Service. Despite guideline recommendations, only a minority of patients receive timely post-discharge follow-up, contributing to clinical deterioration and rising healthcare costs. Existing remote monitoring systems have shown mixed results, primarily due to poor patient adherence, data interpretation challenges, and high costs. While vocal and linguistic analysis supported by Artificial Intelligence (AI) algorithms has shown promise for the early identification of heart failure, its practical application in home monitoring has yet to be systematically evaluated.

AVATAR-SC proposes an accessible, non-invasive platform based on advanced AI technologies. It integrates vocal biomarkers, clinical data, and Patient-Reported Outcome Measures (PROMs) to enhance home monitoring and support a more proactive management of heart failure patients.

Study Population: 60 patients with Heart Failure (HF), including 30 patients discharged following hospitalization for acute heart failure and 30 patients receiving monthly Levosimendan therapy in a Day Hospital setting.

Study Objectives: Although AI-supported vocal and linguistic analysis shows significant potential for the early detection of clinical deterioration in HF patients, there is a lack of data regarding feasibility, acceptability, adherence, integration into care pathways, and data quality within a real-world home monitoring context. A feasibility study is therefore necessary to:i) evaluate patients' ability to use AVATAR-SC independently;ii) estimate adherence to daily vocal data collection;iii) verify the technical performance of the platform;iv) define operational metrics (time, resources, completion rates);v) identify barriers and facilitators in preparation for a large-scale clinical trial.The study does not involve the use of AI systems as clinical tools, nor their application for the automated assessment of an individual patient's health status.Nature and extent of benefits and risks associated with study participation: Potential benefits include more regular symptom monitoring and increased support in disease management. Risks are minimal and primarily concern the use of technology and the processing of personal data.

Intervention: Interactions via digital avatar ≥ 2 times/week, collection of short voice clips, and essential PROMs (Patient-Reported Outcome Measures). No alerts will be generated, and there will be no influence on the patient's clinical pathway.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

60

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

Inclusion Criteria

  • Age ≥ 18 years
  • Diagnosis of heart failure (NYHA Class II-IV), according to the Diagnosis Related Group (DRG) classification.
  • Recent discharge following acute heart failure (AHF) or ongoing treatment with Levosimendan in a Day Hospital setting.
  • Provision of signed informed consent in Italian.
  • Currently receiving Guideline-Directed Medical Therapy (GDMT) for heart failure

Exclusion Criteria:

  • Inability or incapacity to provide informed consent.
  • Cognitive impairment severe enough to prevent interaction with the avatar and compromise the reliability of the collected data.
  • Significant phonation disorders (e.g., results of previous otorhinolaryngological surgery or post-traumatic outcomes).
  • Inability to manage a compatible device or the device provided by the study for interaction with the AVATAR-SC platform.
  • Life expectancy of less than 6 months due to concurrent comorbidities.
  • Technological or language barriers.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Badania usług zdrowotnych
  • Przydział: Nielosowe
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Inny: AVATAR_SC Post-AHF Follow-up
Patients discharged following hospitalization for acute heart failure will be enrolled in this study arm and will utilize AVATAR_SC for periodic monitoring
Inny: AVATAR-SC
Patients discharged following hospitalization for acute heart failure will be enrolled in this study arm and will utilize AVATAR_SC for periodic monitoring
Inny: Standard Care + AVATAR-SC Monitoring
Patients receiving monthly therapy in accordance with standard clinical practice will undergo remote monitoring via the AVATAR-SC platform.
Inny: AVATAR-SC
Patients discharged following hospitalization for acute heart failure will be enrolled in this study arm and will utilize AVATAR_SC for periodic monitoring
Lek: Levosimendan

Patients receiving monthly Levosimendan therapy at the ASST GOM Niguarda (Cardiology 2 - Heart Failure and Transplants) will be enrolled for longitudinal voice data collection. This approach captures data across all preclinical stages of the deterioration-compensation cycle, supported by periodic monitoring via the AVATAR-SC platform.

Levosimendan will be prescribed as per clinical practice. .

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Feasability of the AVATAR-SC System in Heart Failure patients
Ramy czasowe: Through study completion, an average of 3 months per patients
≥80% of patients compleating 75% of scheduled interaction
Through study completion, an average of 3 months per patients

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change in Perceived Quality of Life (QoL)
Ramy czasowe: Through study completion, an average of 3 months per patients
Outcome Measures. A clinical improvement defined as at least a 10% increase in perceived quality of life scores, as measured by standardized Patient-Reported Outcome Measures (KCCQ, EQ-5D).
Through study completion, an average of 3 months per patients
Change in Vocal Biomarkers Score
Ramy czasowe: Through study completion, an average of 3 months per patients
Exploratory offline analysis to evaluate the statistical consistency between vocal patterns and clinical parameters. Quantitative metrics including accuracy, precision, recall, and F1-score will be used for descriptive purposes only. This analysis is purely exploratory, without the definition of clinical thresholds, individual classification, or operational use of the results
Through study completion, an average of 3 months per patients
New York Heart Association (NYHA) Functional Class of Heart Failure
Ramy czasowe: Through study completion, an average of 3 months per patients
Clinical assessment performed by the physician to evaluate the patient's overall heart failure severity and functional limitations based on cardiac symptoms. The evaluation is performed using the New York Heart Association (NYHA) classification, which categorizes patients into one of four classes based on their limitations during physical activit (class I to IV) . Higher classes indicate greater severity of heart failure and worse functional status.
Through study completion, an average of 3 months per patients
Change in Montreal Cognitive Assessment (MoCA) Score
Ramy czasowe: Through study completion, an average of 3 months per patients ]
The MoCA is a screening instrument for cognitive impairment. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. The total score is the sum of all item scores. The scale ranges from 0 to 30, where a score higher than 26 .
Through study completion, an average of 3 months per patients ]
Change in Frontal Assessment Battery (FAB) Score
Ramy czasowe: Through study completion, an average of 3 months per patients
The FAB is a brief tool to assess executive functions. It consists of six subtests (similarities, lexical fluency, motor series, conflicting instructions, go-no-go, and grasping behavior). Total scores range from 0 to 18, where higher scores indicate better executive function.
Through study completion, an average of 3 months per patients
Change in Patient Health Questionnaire-9 (PHQ-9) Score
Ramy czasowe: Through study completion, an average of 3 months per patients
The PHQ-9 is a self-report tool used to screen for and monitor the severity of depression. It consists of 9 items based on the DSM-IV criteria for depression. Each item is scored on a scale from 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 27, where higher scores indicate greater severity of depressive symptoms (e.g., 5-9: mild; 10-14: moderate; 15-19: moderately severe; 20-27: severe).
Through study completion, an average of 3 months per patients
Change in Trail Making Test (TMT)
Ramy czasowe: Through study completion, an average of 3 months per patients
Psychological Well-being as Patient Health Questionnaire-9 (PHQ-9) for depressive symptoms and Generalized Anxiety Disorder-7 (GAD-7) for anxiety levels.
Through study completion, an average of 3 months per patients
Change in Generalized Anxiety Disorder-7 (GAD-7) Score
Ramy czasowe: Through study completion, an average of 3 months per patients
The GAD-7 is a self-report scale for screening and severity measuring of generalized anxiety disorder. It consists of 7 items, each scored from 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 21, where higher scores indicate a higher level of anxiety (e.g., 5-9: mild; 10-14: moderate; 15-21: severe).The SDMT is used to assess psychomotor speed and attention. Patients are given a key matching symbols to numbers and must fill in the correct numbers for a series of symbols within 90 seconds. The score is the number of correct substitutions. Scores typically range from 0 to 110. A higher score indicates better cognitive processing speed and attention.
Through study completion, an average of 3 months per patients
Change in Symbol Digit Modalities Test (SDMT) Score
Ramy czasowe: Through study completion, an average of 3 months per patients
The SDMT is used to assess psychomotor speed and attention. Patients are given a key matching symbols to numbers and must fill in the correct numbers for a series of symbols within 90 seconds. The score is the number of correct substitutions. Scores typically range from 0 to 110. A higher score indicates better cognitive processing speed and attention.
Through study completion, an average of 3 months per patients

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Niguarda Hospital

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

30 czerwca 2026

Zakończenie podstawowe (Szacowany)

15 maja 2027

Ukończenie studiów (Szacowany)

15 maja 2028

Daty rejestracji na studia

Pierwszy przesłany

14 kwietnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

17 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

24 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

24 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

17 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 7005
  • InnovaWalfare 2025-0158 (Inny numer grantu/finansowania: InnovaWalfare 2025-0158)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

Individual Participant Data (IPD) will not be made publicly available to ensure strict compliance with EU Regulation 2016/679 (GDPR) and to protect patient privacy regarding sensitive vocal recordings. All collected data, including audio tracks and clinical features, are processed in a pseudo-anonymous form using non-reversible alphanumeric codes. The link log connecting these codes to patients' identities is stored exclusively at the coordinating center (ASST GOM Niguarda) and is not accessible to other partners or third parties.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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