Hearables: Ear-ECG and PPG for Detection of Cardiac Arrhythmias
NCT ID: NCT06667258
Last Updated: 2024-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2024-10-31
2024-12-31
Brief Summary
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* 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
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Healthy
Volunteers who have not been diagnosed with any heart rhythm problems, or patients whose heart rhythm issues are not showing up at the time of recruitment.
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
Arrhythmia patients
Patients who have been previously diagnosed with an abnormal heart rhythm and are showing signs of it when they join the study.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Healthy and diagnosed with cardiac arrhythmias.
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Imperial College London
OTHER
Responsible Party
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Principal Investigators
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Nicholas S. Peters, MD
Role: PRINCIPAL_INVESTIGATOR
Imperial College London
Locations
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Imperial College Healthcare NHS Trust
London, Non-US/Non-Canadian, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Patrik Bachtiger
Role: primary
References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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318229
Identifier Type: OTHER
Identifier Source: secondary_id
22HH7866
Identifier Type: -
Identifier Source: org_study_id