Hearables: Ear-ECG and PPG for Detection of Cardiac Arrhythmias
- Conditions
- Arrhythmia
- Registration Number
- NCT06667258
- Lead Sponsor
- Imperial College London
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- Able to give informed consent;
- Healthy and diagnosed with cardiac arrhythmias.
- No abnormal ear anatomy
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of arrhythmia detection in the group of participants Up to 6 months from study completion Accuracy in detecting and classifying arrhythmias from signals recorded from the ears of patients with or without arrhythmia (Protocol 1)
- Secondary Outcome Measures
Name Time Method Signal to Noise Ratio Up to 6 months from study completion The Signal quality of Ear-ECG expressed as Signal to Noise ratio evaluated against 1-lead 'Rhythm strip' ECG at rest (Protocol 1)
Signal quality improvement after artefact removal (expressed as difference) Up to 6 months from study completion Noise reduction from Ear-ECG and Ear-PPG after removal of artefacts that may be due to movement (Protocol 2)
Error in blood pressure estimation by comparing ear-ECG and ear-PPG signals Up to 6 months from study completion Accuracy of estimating blood pressure by subtracting the ear-ECG and ear-PPG peak time location (Protocol 3)
Trial Locations
- Locations (1)
Imperial College Healthcare NHS Trust
🇬🇧London, Non-US/Non-Canadian, United Kingdom