Predicting Acute Exacerbations of COPD Using Wearable Devices and Remote Monitoring Technology With AI/ML Models

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-22

Study Completion Date

2026-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study is aimed to collect real-time physiological data using two wearable devices (a biometric ring and a biometric wristband), daily lung mechanical measurements by a handheld oscillometer, and participant-reported symptoms in patients with COPD remotely from their home environment. The data will be used to train and validate artificial intelligence and machine learning (AI/ML) models to predict COPD exacerbations in advance of their actual occurrence. The data will also be used to test the new severity classification system for exacerbations of COPD, as well as to determine important relationships between physiological measurements from the wearable devices, the handheld oscillometer, the self-reported symptoms, and the tests performed at the baseline visit.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Remote Monitoring of COPD Patients Experiencing an Acute Exacerbation Through Health Evaluations Using Wearable Mobile Technology

NCT06890767

Chronic Obstructive Pulmonary Disease (COPD) Acute Exacerbation of COPD

RECRUITING NA

Physiological and Environmental Data in a Remote Setting to Predict Exacerbation Events in Patients With Chronic Obstructive Pulmonary Disease

NCT06118632

COPD Exacerbation

UNKNOWN

Pilot Study for the Application of Low Power External Bioelectronic Devices in the Diagnosis of Bronchial Asthma.

NCT06836375

Asthma Bronchiale

NOT_YET_RECRUITING

The Use of Home-monitoring and mHealth Systems to Predict Asthma Control and the Occurrence of Asthma Exacerbations

NCT02774772

Asthma

COMPLETED

Monitoring Chronic Obstructive Pulmonary Disease Patients at Home by a Forced Oscillation Technique Device

NCT01552031

COPD

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

A single-site, prospective, observational cohort study to collect high-quality multidimensional data from the wearable/portable devices, as well as symptom and exacerbation data, in high-risk patients with frequent exacerbations in order to develop a COPD exacerbation predictive model.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COPD AE COPD

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Biometric wearable and handheld devices

In this study, participants will be equipped with biometric wearable devices, i.e. ring and wristband, as well as with a handheld oscillometer, to measure their physiological parameters and lung mechanical changes (lung function).

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Males/females, age ≥ 40, former/current smokers with ≥10 pack-year smoking history
* FEV1/FVC \< 0.7, with 80% \< FEV1 ≤50% (moderate, 'GOLD 2') 50% \< FEV1 ≤ 30% (severe, 'GOLD 3') or FEV1 \< 30% (very severe, 'GOLD 4') COPD
* History of 2 or more exacerbations in the preceding 12 months requiring corticosteroids, antibiotics, or both
* Ability to provide informed consent
* Ability to access internet at least once daily

Exclusion Criteria

* No existing COPD diagnosis
* Any medical/cognitive/functional condition which renders inability to operate research equipment/devices, and/or to complete daily symptom response

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No