Hearables: Ear-ECG and PPG for Detection of Cardiac Arrhythmias
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ear ECG/PPG sensors.
- Who it may be relevant to
- Registry conditions: Arrhythmia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Hearables: Ear Electrocardiography (ECG) and Photoplethysmography (PPG) for Real-time Detection of Cardiac Arrhythmias
Overview
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.
Interventions
- Device Ear ECG/PPG sensors
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
Primary outcome measures
- Percentage of arrhythmia detection in the group of participants [Time frame: Up to 6 months from study completion]
Secondary outcome measures (3)
- Signal to Noise Ratio [Time frame: Up to 6 months from study completion]
- Signal quality improvement after artefact removal (expressed as difference) [Time frame: Up to 6 months from study completion]
- Error in blood pressure estimation by comparing ear-ECG and ear-PPG signals [Time frame: Up to 6 months from study completion]
Eligibility criteria
Inclusion criteria
- Able to give informed consent;
- Healthy and diagnosed with cardiac arrhythmias.
Exclusion criteria
- No abnormal ear anatomy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United Kingdom · 1 center
- Imperial College Healthcare NHS Trust — London
Publications
- von Rosenberg W, Chanwimalueang T, Goverdovsky V, Peters NS, Papavassiliou C, Mandic DP. Hearables: feasibility of recording cardiac rhythms from head and in-ear locations. R Soc Open Sci. 2017 Nov 15;4(11):171214. doi: 10.1098/rsos.171214. eCollection 2017 Nov. PMID 29291107
Identifiers
NCT: NCT06667258 · 22HH7866 · 318229