An interventional study of hypoxia in Oximetry, sponsored by Withings. Completed at 1 site in United States. Open to participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-04.
Sponsored by Withings · Not applicable, Interventional, and Diagnostic
Performance testing of pulse oximeters. The protocol involves brief stable arterial oxygen desaturation in healthy volunteers and sampling arterial blood when a stable level of hypoxia has been attained. The blood sample is analyzed for oxygen saturation with a gold standard bench CO-oximeter. This protocol is aligned with the latest ISO and FDA guidance documents for pulse oximeter testing.
Withings is the lead sponsor of 23 studies on the registry; 3 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Diagnostic Test: hypoxia
Brief stable arterial oxygen desaturation in healthy volunteers and sampling arterial blood when a stable level of hypoxia has been attained.
RMSE Compared to CO-oximetry
Root Mean Squared Error between the functional blood oxygen saturation (SpO2) provided by the device under test and the arterial blood oxygen measured with the CO-oximeter.
Time frame: 1 hour
First enrolment: 2020/03/11 Last subject completed: 2020/03/12 The study included eligible volunteers at UCSF. The investigators selected subjects, balanced in terms of gender, age, and skin pigmentation. Participation to the study was offered to the subjects until the target headcounts was reached.
| Milestone | Left vs Right Hand |
|---|---|
| Started | 14 |
| Completed | 14 |
| Not completed | 0 |
Root Mean Squared Error between the functional blood oxygen saturation (SpO2) provided by the device under test and the arterial blood oxygen measured with the CO-oximeter.
| RMSE (%) | Left Bias | Right Bias |
|---|---|---|
| RMSE Compared to CO-oximetry | 2.97 | 3.00 |
Collected over On the day of the visit. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Left vs Right Hand | 0/14 (0%) | 0/14 (0%) | 0/14 (0%) |
| Age, Continuous(year) | Left vs Right Hand |
|---|---|
| Mean | 27.1 ± 3.9 |
| Sex: Female, Male(Participants) | Left vs Right Hand |
|---|---|
| Female | 6 |
| Male | 8 |
| Race and Ethnicity Not Collected(Participants) | Left vs Right Hand |
|---|
| Skin tone(Participants) | Left vs Right Hand |
|---|---|
| Fair skin tone | 4 |
| Medium skin tone | 7 |
| Dark skin tone | 3 |
| BMI (kg/m²)(kg.m-²) | Left vs Right Hand |
|---|---|
| Mean | 23.4 ± 2.1 |
| Height(cm) | Left vs Right Hand |
|---|---|
| Mean | 168.7 ± 9.8 |
| Weight(kg) | Left vs Right Hand |
|---|---|
| Mean | 66.6 ± 8.6 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.