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NCT Number: NCT06667258

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Imperial College Healthcare NHS Trust

London, Non-US/Non-Canadian, E5 0LJ, United Kingdom

Location status: Recruiting

Location contact

Patrik Bachtiger

CONTACT

[email protected]

07814396281

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • No abnormal ear anatomy

Treatment and study plan

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

Primary outcomes

  1. Percentage of arrhythmia detection in the group of participants

    Time frame: 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 outcomes

  1. Signal to Noise Ratio

    Time frame: 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)

  2. Signal quality improvement after artefact removal (expressed as difference)

    Time frame: 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)

  3. Error in blood pressure estimation by comparing ear-ECG and ear-PPG signals

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Cheuk F. Wong

CONTACT

[email protected]

02075949832

Patrik Bachtiger, MBBS

CONTACT

[email protected]

07814396281

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 31, 2024
Registry last updated
Oct 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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