AI-ACLD Study: Artificial Intelligence in Advanced Chronic Liver Disease

NCT07721454 | Completed

• 1 other identifier: AI-ACLD Study
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The research project studies the possibility of using an artificial intelligence-based system in patients with advanced chronic liver disease (liver cirrhosis) to record variations in a patient's health status, with the aim of early identification of clinical improvement or deterioration. The system is based on the collection and processing of various clinical parameters through an Apple Watch. The study aims to evaluate whether the data generated by this system correlate with patients' clinical evolution and whether its use may ultimately contribute to improved care management and quality of life.

Conditions

Advance Chronic Liver Disease (ACLD)

Outcome Measures

Primary Outcomes (1)

• Feasibility and accuracy of machine learning analysis of individual health data collected by wearable device.

  The primary outcome is to assess the feasibility and accuracy of machine learning analysis of individual health data collected by wearable device and to describe their patterns during hospitalization due to symptoms of decompensation or ACLF and in outpatients until hospitalization due to decompensation or ACLF in patients with liver cirrhosis. Health data continuously collected through a dedicated wearable device application comprise: heart rate and heart rate variability (HR; HRV), oxygen saturation (SpO₂), ECG (QRS, PQ, PT Tpe interval), sleep quality and duration, daily step count, tremor intensity (Hz), typing speed (taps/time). The single unit of measure used to assess the feasibility of the wearable device is the usable data acquisition rate (%), defined as the percentage of monitoring data successfully collected and suitable for analysis.

  From enrollment to the end of the study (6 months)

Interventions

Apple Watch DEVICE

Apple Watch has been used to specifically monitor patients with liver cirrhosis, who worn it for the period specified by the study

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients hospitalized at Ente Ospedaliero Cantonale (EOC) in Lugano or Bellinzona or patients followed at the Department for Gastroenterology and Hepatology, Ente Ospedaliero Cantonale will be assessed for inclusion in the study

You may qualify if:

• Adults aged 18-75 years
• Diagnosis of advanced chronic liver disease (ACLD).
• Either:
• hospitalized for hepatic decompensation or acute-on-chronic liver failure (ACLF), including ascites, hepatorenal syndrome, hepatic encephalopathy, bacterial infection, gastrointestinal bleeding, or jaundice; or
• outpatient with Child-Pugh B cirrhosis and no evidence of hepatic decompensation or ACLF at enrolment.
• Willing and able to provide written informed consent.

You may not qualify if:

• Inability or refusal to provide written informed consent
• Inability to wear or correctly use the Apple Watch
• Patients with hepatocellular carcinoma beyond the Milan Criteria (one lesion up to 5 cm or 3 lesions up to 3 cm in diameter)
• Presence of hepatic decompensation or ACLF

Sponsors & Collaborators

• Antonio Galante: lead

Study Sites (1)

Ente Ospedaliero Cantonale

Lugano, 6900, Switzerland

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 23, 2026
• Study Start: December 29, 2022
• Primary Completion: January 17, 2024
• Study Completion: January 17, 2024
• Last Updated: July 23, 2026

Record last verified: 2026-07

Locations

CH (1)