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| ID | Type | Description | Link |
|---|---|---|---|
| 318229 | Other Identifier | IRAS |
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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:
Researchers will compare data from healthy controls and arrhythmia patients to see if ear-based recordings are as effective as traditional methods.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Arrhythmia patients | Patients who have been previously diagnosed with an abnormal heart rhythm and are showing signs of it when they join the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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50 healthy patients and 50 patients with an established diagnosis of cardiac arrhythmias
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patrik Bachtiger, MBBS | Contact | 07814396281 | p.bachtiger@imperial.ac.uk | |
| Cheuk F. Wong | Contact | 02075949832 | cheuk-fung.wong@imperial.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Nicholas S. Peters, MD | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial College Healthcare NHS Trust | Recruiting | London | Non-US/Non-Canadian | E5 0LJ | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29291107 | Background | 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. |
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Held within Imperial College London as per standard local data protection guidelines. Data may be considered for sharing upon reasonable request.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 30, 2023 | Oct 23, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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 |