Skip to main content
UK clinical trials - updated daily from ClinicalTrials.gov
TrialConnect
← Back to Search
Looking for participantsN/A

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

Sponsor: Imperial College London

NCT ID: NCT06667258

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Ear ECG/PPG sensors (device)
How long the study runs
Study runs about 2 months (dates as stated)
About the drug or intervention
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
Patient visit burden
Not specified by the sponsor
Type of study
Observing health over time
Ages
18 Years and over
Who
All
Number of participants
100
Started
2024-10
Last checked
2024-10

Plain English Summary

What is this study?

  • • Testing a new treatment for arrhythmia
  • • Clinical study - 100 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with arrhythmia

Where?

  • • London - Imperial College Healthcare NHS Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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.

Arrhythmia

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓Able to give agreement to take part;
  • ✓Healthy and diagnosed with heart arrhythmias.

Who cannot take part

  • ✗No abnormal ear anatomy
See the full criteria
Inclusion Criteria: * Able to give informed consent; * Healthy and diagnosed with cardiac arrhythmias. Exclusion Criteria: * No abnormal ear anatomy

Where Is This Study? (1 UK site)

Imperial College Healthcare NHS Trust

London E5 0LJ, United Kingdom

Recruiting
Site contact (verified)

How to Get in Touch

Patrik Bachtiger, MBBS

Sponsor contact

CONTACT

07814396281 p.bachtiger@imperial.ac.uk

Cheuk F. Wong

Sponsor contact

CONTACT

02075949832 cheuk-fung.wong@imperial.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2024-10