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

NCT06667258 | Recruiting DMC

• 2 other identifiers: 22HH7866318229
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Arrhythmia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Signal to Noise Ratio

  Up to 6 months from study completion

• Signal quality improvement after artefact removal (expressed as difference)

  Up to 6 months from study completion

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

  Up to 6 months from study completion

Study Arms (2)

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

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

Interventions

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

Arrhythmia patients; Healthy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• No abnormal ear anatomy

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Imperial College Healthcare NHS Trust

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

RECRUITING

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nicholas S. Peters, MD

  Imperial College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrik Bachtiger, MBBS

CONTACT

07814396281; p.bachtiger@imperial.ac.uk

Cheuk F. Wong

CONTACT

02075949832; cheuk-fung.wong@imperial.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: October 31, 2024
• Study Start: October 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 31, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)