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Hearables: Ear-ECG and PPG for Detection of Cardiac Arrhythmias

Hearables: Ear Electrocardiography (ECG) and Photoplethysmography (PPG) for Real-time Detection of Cardiac Arrhythmias

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06667258
Enrollment
100
Registered
2024-10-31
Start date
2024-10-31
Completion date
2024-12-31
Last updated
2024-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arrhythmia

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.

Interventions

DEVICEEar 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

Sponsors

Imperial College London
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Able to give informed consent; * Healthy and diagnosed with cardiac arrhythmias.

Exclusion criteria

* No abnormal ear anatomy

Design outcomes

Primary

MeasureTime frameDescription
Percentage of arrhythmia detection in the group of participantsUp to 6 months from study completionAccuracy in detecting and classifying arrhythmias from signals recorded from the ears of patients with or without arrhythmia (Protocol 1)

Secondary

MeasureTime frameDescription
Signal to Noise RatioUp to 6 months from study completionThe 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 completionNoise 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 signalsUp to 6 months from study completionAccuracy of estimating blood pressure by subtracting the ear-ECG and ear-PPG peak time location (Protocol 3)

Countries

United Kingdom

Contacts

Primary ContactPatrik Bachtiger, MBBS
p.bachtiger@imperial.ac.uk07814396281
Backup ContactCheuk F. Wong
cheuk-fung.wong@imperial.ac.uk02075949832

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026