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

Hearables: Ear Electrocardiography (ECG) and Photoplethysmography (PPG) for Real-time 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.

Study Overview

• Status: Recruiting
• Conditions: Arrhythmia
• Intervention / Treatment: Device: Ear ECG/PPG sensors

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Patrik Bachtiger, MBBS; Phone Number: 07814396281; Email: p.bachtiger@imperial.ac.uk
• Study Contact Backup: Name: Cheuk F. Wong; Phone Number: 02075949832; Email: cheuk-fung.wong@imperial.ac.uk

Study Locations

• United Kingdom
  • Non-US/Non-Canadian
    • London, Non-US/Non-Canadian, United Kingdom, E5 0LJ
      • Recruiting
      • Imperial College Healthcare NHS Trust
      • Contact: Patrik Bachtiger; Phone Number: 07814396281; Email: p.bachtiger@imperial.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

50 healthy patients and 50 patients with an established diagnosis of cardiac arrhythmias

Description

Inclusion Criteria:

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

Exclusion Criteria:

• No abnormal ear anatomy

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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
Arrhythmia patients; Patients who have been previously diagnosed with an abnormal heart rhythm and are showing signs of it when they join the study.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of arrhythmia detection in the group of participants	Accuracy in detecting and classifying arrhythmias from signals recorded from the ears of patients with or without arrhythmia (Protocol 1)	Up to 6 months from study completion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Signal to Noise Ratio	The Signal quality of Ear-ECG expressed as Signal to Noise ratio evaluated against 1-lead 'Rhythm strip' ECG at rest (Protocol 1)	Up to 6 months from study completion
Signal quality improvement after artefact removal (expressed as difference)	Noise reduction from Ear-ECG and Ear-PPG after removal of artefacts that may be due to movement (Protocol 2)	Up to 6 months from study completion
Error in blood pressure estimation by comparing ear-ECG and ear-PPG signals	Accuracy of estimating blood pressure by subtracting the ear-ECG and ear-PPG peak time location (Protocol 3)	Up to 6 months from study completion

Collaborators and Investigators

• Sponsor: Imperial College London
• Investigators: Principal Investigator: Nicholas S. Peters, MD, Imperial College London

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: October 24, 2024
• First Submitted That Met QC Criteria: October 29, 2024
• First Posted (Actual): October 31, 2024

Study Record Updates

• Last Update Posted (Actual): October 31, 2024
• Last Update Submitted That Met QC Criteria: October 29, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: 22HH7866; 318229 (Other Identifier: IRAS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Held within Imperial College London as per standard local data protection guidelines. Data may be considered for sharing upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No