Using smartphone data to monitor heart conditions
Combining Accelerometer, Gyroscope, Sound, Electrocardiography and Photoplethysmography Data in Cardiac Monitoring: a Pilot Study
This study is testing if using smartphone data like heart rate and movement can help monitor heart conditions better for both healthy people and those with atrial fibrillation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 125 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Qompium NV Industry-sponsored |
| Locations | 1 site (Genk, Limburg) |
| Trial ID | NCT06422468 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to explore the effectiveness of combining various smartphone-derived data, including photoplethysmography (PPG), accelerometer (ACC), gyroscope (GYR), sound, and electrocardiography (ECG) signals, to enhance cardiac monitoring for individuals with and without atrial fibrillation (AF). Participants will be divided into groups of healthy volunteers and cardiology patients to assess the insights gained from this multi-faceted approach. The study will utilize FibriCheck recordings as part of the intervention to gather data on heart conditions.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older, both healthy volunteers and patients with atrial fibrillation or other cardiac conditions.
Not a fit: Patients with conditions that affect signal quality, such as unnaturally colored fingers or tremors, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cardiac monitoring techniques that provide more accurate insights into heart conditions.
How similar studies have performed: While the combination of these specific data types is relatively novel, similar approaches in cardiac monitoring have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Inclusion criteria applicable for all groups: * At least 18 years old * Participants must have the ability to understand and provide written informed consent * Participants must have the ability to understand Dutch Group specific inclusion criteria: Group 1: Healthy volunteers * No cardiac conditions based on medical history. Group 2: Cardiology patients * Patients at the consultation or ambulatory unit of Cardiology (pre- cardioversion, pre-pulmonary vein isolation) with AF. * Patients without AF but with a current cardiac condition (e.g. heart failure with a reduced or preserved ejection fraction) or a history of a cardiac condition (e.g. history of myocardial infarction). Exclusion Criteria: * Individuals with unnaturally coloured fingers (i.e. tattoos, ink); this may weaken the signal and may interfere with the effectiveness of the device * Persons with conditions causing tremors or the inability to hold their hand still for at least 60 seconds (e.g. Parkinson or dementia) as, in this case, the device may not be able to accurately process a measurement * Persons with reduced blood flow in the fingertips (e.g. perniosis or severe callus formation) as the device may not be able to detect the intensity variations induced by the blood flow * Persons that have a disability to perform the measurements according to the instructions for use * Persons with cardiac pacemakers, implantable cardioverter-defibrillators, or other implanted electronic devices as these can control the natural heart rhythm
Where this trial is running
Genk, Limburg
- Ziekenhuis Oost Limburg — Genk, Limburg, Belgium (Recruiting)
Study contacts
- Principal investigator: Pieter Vandervoort, MD — Ziekenhuis Oost-Limburg
- Study coordinator: Lars Grieten, PhD
- Email: Lars.Grieten@fibricheck.com
- Phone: +3211485953
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.