Clinical trial NCT06667258: Hearables: Ear-ECG and PPG for Detection of Cardiac Arrhythmias
Official title: Hearables: Ear Electrocardiography (ECG) and Photoplethysmography (PPG) for Real-time Detection of Cardiac Arrhythmias
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Arrhythmia
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2024-10-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 50 healthy patients and 50 patients with an established diagnosis of cardiac arrhythmias

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* No abnormal ear anatomy

Primary outcomes:
measure: Percentage of arrhythmia detection in the group of participants
timeFrame: Up to 6 months from study completion
Secondary outcomes:
measure: Signal to Noise Ratio
timeFrame: Up to 6 months from study completion
measure: Signal quality improvement after artefact removal (expressed as difference)
timeFrame: Up to 6 months from study completion
measure: Error in blood pressure estimation by comparing ear-ECG and ear-PPG signals
timeFrame: Up to 6 months from study completion
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
state: Non-US/Non-Canadian
Study officials:
affiliation: Imperial College London
name: Nicholas S. Peters, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.