EARSATS-19: In-ear Measurement of Blood Oxygen Saturation in COVID-19 Follow up

NCT04529408 | Completed DMC

• 1 other identifier: 285603
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

TITLE EARSATS-19: In-ear measurement of blood oxygen saturation in COVID-19 follow up DESIGN Non-inferiority study AIMS To evaluate qualitative and quantitative performance of in-ear 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 OUTCOME MEASURES In-ear SpO2 compared with gold-standard finger-clip pulse oximeter: Correlation between SpO2 measurements at rest Correlation between SpO2 measurements during 6 minute walk test Signal quality during 6 minute walk test Qualitative evaluation of clinical and patient user acceptability using questionnaires POPULATION 30 patients attending COVID-19 follow-up clinic and 30 patients with chronic lung disease attending routine outpatient investigations ELIGIBILITY Aged 18 and above, no upper age limit Able to give informed consent No abnormal ear anatomy. DURATION 12 months

Conditions

Covid19; Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• In-Ear vs finger SpO2

  Mean error and root mean square error; measurements for statistical significance using a paired t-test.

  12 months for full participant recruitment (actual head-to head comparison takes 1 minute for baseline reading and 6 minutes for 6-min walk test per patient)

Study Arms (2)

COVID-19 Follow up clinic

Patients attending routine post-COVID-19 follow up clinic

Device: EarSats Pulse Oximeter Probe

Pulmonary Disease clinic

Patients attending routine outpatient appointment for pulmonary disease

Device: EarSats Pulse Oximeter Probe

Interventions

EarSats Pulse Oximeter Probe DEVICE

Off-the-shelf pulse oximeter embedded into a memory foam ear plug for measuring blood oxygen saturation (SpO2) from the ear canal; in-ear SpO2 measured at-rest and during 6 minute walk test

COVID-19 Follow up clinic; Pulmonary Disease clinic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Outpatient population attending either COVID-19 follow up or chronic respiratory disease clinic

You may qualify if:

• Patients attending respiratory clinic either for COVID-19 follow up or for chronic lung disease.
• Able to give informed consent (where not able to use CIE, paper consent form will be made available)

You may not qualify if:

• Abnormal ear canal anatomy

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Imperial College Healthcare NHS Trust

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

Location

Related Publications (1)

• Goverdovsky V, von Rosenberg W, Nakamura T, Looney D, Sharp DJ, Papavassiliou C, Morrell MJ, Mandic DP. Hearables: Multimodal physiological in-ear sensing. Sci Rep. 2017 Jul 31;7(1):6948. doi: 10.1038/s41598-017-06925-2.

  PMID: 28761162 BACKGROUND

MeSH Terms

Conditions

COVID-19; Lung Diseases

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Respiratory Tract Diseases

Study Officials

• Nicholas Peters, MD

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: August 27, 2020
• Study Start: August 26, 2020
• Primary Completion: August 10, 2022
• Study Completion: August 10, 2022
• Last Updated: October 17, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)