EARSATS-19 V1.0 [COVID-19]
Research type
Research Study
Full title
EARSATS-19: In-ear measurement of blood oxygen saturation in COVID-19 follow up\n
IRAS ID
285603
Contact name
Nicholas Peters
Contact email
Sponsor organisation
Imperial College London
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Research Summary:
\nTITLE\nEARSATS-19: In-ear measurement of blood oxygen saturation in COVID-19 follow up\n\n\nDESIGN\nNon-inferiority study (to show new technology is as good or possibly better than what we currently use)\n\nAIMS\nTo evaluate qualitative and quantitative performance of in-ear pulse oximetry (SpO2) monitoring against the gold standard right finger-clip pulse oximeter -- towards validation for use in COVID-19 in the acute ambulatory and long-term monitoring setting \n\nOUTCOME MEASURES\nIn-ear SpO2 compared with gold-standard finger-clip pulse oximeter:\n- Correlation between SpO2 measurements at rest \n- Correlation between SpO2 measurements during 6 minute walk test\n- Signal quality during 6 minute walk test\n- Qualitative evaluation of clinical and patient user acceptability using questionnaires\n\nPOPULATION\n30 patients attending COVID-19 follow-up clinic and 30 patients with chronic lung disease attending routine outpatient investigations (baseline SpO2 measurement and 6 minute walk test)\n\nELIGIBILITY\nAged > 18, no upper age limit\nAble to give informed consent\nNo abnormal ear anatomy.\n\nDURATION\n6 months initial phase\n
Lay Summary of Results:
This study shows that tiny sensors placed in the ear can capture breathing patterns more accurately than sensors on the finger. Using advanced data analysis, researchers were able to recreate detailed breathing waveforms—similar to those from hospital breathing tests—just from ear-based signals. They tested this on healthy people (young and old), patients with lung diseases like COPD and pulmonary fibrosis. The ear-based signals showed clear differences in breathing patterns for COPD patients, which allowed the system to correctly identify COPD with high accuracy. This suggests that in-ear sensors could be used in the future for easy, non-invasive monitoring of breathing and early detection of lung problems, even through everyday wearable devices.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
20/SC/0315
Date of REC Opinion
19 Aug 2020
REC opinion
Further Information Favourable Opinion