Healthy volunteers Other
Conditions
Interventions
This study is a comparative, single-centre, non-randomised study with a minimum of 24 subjects. Each subject test is expected to take approximately 3-4 hours. The overall data collection process will
Sponsors
EarSwitch Ltd
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Age 18 to 55 years 2. Willing and capacity to provide written informed consent 3. Healthy adult subjects (American Society of Anesthesiologists [ASA] 1) 4. Non-smoker 5. Willing and able to comply with study procedures and duration
Exclusion criteria
Exclusion criteria: 1. Smokers or individuals exposed to high levels of carbon monoxide 2. Compromised circulation, injury, or physical malfunction of the sensor sites which would limit the ability to test sites needed for the study. 3. Morbidly obese (de?ned as BMI >39.5 kg/m²) or significantly underweight (BMI <18 kg/m²) 4. Female subjects that are actively trying to get pregnant or are pregnant. N.B. All female participants will need to complete a pregnancy test 5. Female subjects unwilling to perform a urinary pregnancy test. 6. Unwillingness or inability to remove coloured nail polish or nail attachments from test digits (relevant for reference pulse oximeter) or to have medical monitoring attached. 7. Known health conditions disclosed on Health Assessment Form which mean that participant is not healthy 8. Allergy to lidocaine 9. Allergy to adhesives used in medical dressings or tapes or materials used in EarMetrics earpieces (Please refer to the Investigators Brochure ES026 1 0850) 10. Diagnoses- past and present: Ear wax impaction, chronic otitis externa, acute otitis media, cholesteatoma, tympanic membrane perforation 11. Symptoms of ear infection or inflammation as indicated by in-ear pain, discharge and/or irritation. 12. Use of hearing aids 13. Enrolment in any other clinical investigation (co-enrolment)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Performance: validation of the EarMetrics®-Oximeter Validation Device's ability to evaluate the SpO2 in comparison to the “gold-standard” measurement of blood SaO2 by a co-oximeter, measured using a sequence of arterial blood gas samples taken as per a one-off standardised desaturation procedure. 2. Safety: safety of the EarMetrics®-Oximeter pulse oximeter measured through the monitoring of device-related adverse events. Adverse events were monitored throughout the desaturation procedure and one day after the procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Usability, utility, positioning and fit and comfort of the device are measured with a one-off non-validated participant survey completed after the desaturation procedure | — |
Countries
England, United Kingdom
Contacts
Public ContactDhruv Parekh
Outcome results
None listed