At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Ear ECG/PPG sensors (device)
- How long the study runs
- Study runs about 2 months (dates as stated)
- About the drug or intervention
- Ear ECG/PPG sensors — device: Medical graded electrodes placed in the mastoid, in-ear foam-based earpiece (like commercial earplugs) with cloth electrodes, off-the-shelf pulse oximeter placed behind the ear
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Observing health over time
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 100
- Started
- 2024-10
- Last checked
- 2024-10
Plain English Summary
What is this study?
- • Testing a new treatment for arrhythmia
- • Clinical study - 100 participants
- • The goal of this observational study is to determine the feasibility of detecting abnormal heart rhythms, known as arrhythmias, by recording Electrocardiogram (ECG) and Photoplethysmogram (PPG) waveforms from the ears in patients who have already been diagnosed with arrhythmias
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with arrhythmia
Where?
- • London - Imperial College Healthcare NHS Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The goal of this observational study is to determine the feasibility of detecting abnormal heart rhythms, known as arrhythmias, by recording Electrocardiogram (ECG) and Photoplethysmogram (PPG) waveforms from the ears in patients who have already been diagnosed with arrhythmias. The main questions it aims to answer are: * Can ECG and PPG signals from the ears reliably detect arrhythmias? * How do ear-based ECG/PPG waveforms compare to standard single-lead ECG in detecting abnormal rhythms? Researchers will compare data from healthy controls and arrhythmia patients to see if ear-based recordings are as effective as traditional methods.
More detail
The main goal of this study is to determine the feasibility of detecting abnormal heart rhythms, known as arrhythmias, by recording Electrocardiogram (ECG) and Photoplethysmogram (PPG) waveforms from the ears. The study includes both healthy control subjects and patients who have already been diagnosed with arrhythmias. These individuals will be approached by a clinical member of the research team during their hospital stay or outpatient visit at Imperial College NHS Trust (ICHNT). Patients will be given comprehensive information about the study through a patient information sheet and will be asked for their written informed consent, with adequate time provided for questions and understanding. To capture Ear-ECG/PPG waveforms, a variety of standard medical-grade sensors and electrodes will be placed in and around both ears. These include standard EEG electrodes on each mastoid secured with medical-grade gel, and an in-ear foam-based earpiece (like commercial earplugs) with cloth electrodes. An additional PPG sensor (MAX30101 from Maxim Integrated) will be attached to the back of the ear with adhesive medical tape. The patient will also be connected to a standard single-lead ECG and a blood pressure cuff, already part of their standard care on the hospital ward. Once the setup is complete, each patient will follow 3 different recording protocols displayed on a screen. Patients will be asked to sit upright (Protocol 1) and engage in a series of simple activities with designated breaks in between, including head movements, counting aloud to 60, chewing gum (or simulating chewing), walking (if able) freely under medical supervision with assistance if needed (Protocol 2), slow controlled breathing and immersing their hand in cold water (Protocol 3). The total recording time including setup will be approximately 20 minutes.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓Able to give agreement to take part;
- ✓Healthy and diagnosed with heart arrhythmias.
Who cannot take part
- ✗No abnormal ear anatomy
See the full criteria
Where Is This Study? (1 UK site)
Imperial College Healthcare NHS Trust
London E5 0LJ, United Kingdom
How to Get in Touch
Patrik Bachtiger, MBBS
Sponsor contactCONTACT
Cheuk F. Wong
Sponsor contactCONTACT
