HypoxiaNCT07408388
Pulse Oximeter Accuracy During Stable Hypoxia Plateaus
An observational study of Hypoxia, run by Nihon Kohden at 1 site in United States.
Trial summary
The aim of this study is to determine the accuracy of devices called pulse oximeters, which measure blood oxygen by shining light through fingers, ears or other skin, without requiring blood sampling. Study will be used with healthy volunteers at rest. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypoxia
- What is being tested?
- Pulse Oximeter and Induced hypoxia through breathing nitrogen-air-carbon dioxide mixture
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2025to 1 Dec 2027
- How long will I take part?
- 1 Week
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy adult volunteers. At least 48 new subjects will be enrolled. Subjects will be selected with reference to ISO and FDA requirements to ensure appropriate representation across skin tone categories (Monk Skin Tone scale) and sex.
Who may be able to join
- The subject is male or female, aged 18 to 50.
- The subject is in good general health with no evidence of any medical problems
- The subject is fluent in both written and spoken English.
- The subject has provided informed consent and is willing to comply with the study procedures.
Who cannot join
- The subject has a BMI above 40
- The subject has blood pressure above 160 systolic or 95 diastolic
- The subject has a known history of heart disease, lung disease, kidney or liver disease.
- Diagnosis of asthma, sleep apnea, or use of CPAP.
- Subject has diabetes.
- Subject has a clotting disorder.
Show all 18Show fewer
- The subject has a hemoglobinopathy or history of anemia, per subject report or the first blood sample, that in the opinion of the investigator, would make them unsuitable for study participation. (COHb<3%, MetHb<2%, ctHb>10 g/dL).
- The subject has any other serious systemic illness.
- The subject has smoked in the last 12 hours.
- Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators would interfere with the sensors working correctly.
- The subject has a history of fainting or vasovagal response.
- The subject has a history of sensitivity to local anesthesia.
- The subject has a diagnosis of Raynaud's disease.
- The subject has unacceptable collateral circulation based on exam by the investigator (Allen's test).
- The subject is pregnant, lactating or trying to get pregnant.
- Subjects who have uneven skin tones at the forehead or the sensor site.
- The subject is unable or unwilling to provide informed consent or is unable or unwilling to comply with study procedures.
- The subject has any other condition, which in the opinion of the investigators would make them unsuitable for the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vital Sign Research Group
San Francisco, California, 94107
About this study
The aim of this study is to determine the accuracy of devices called pulse oximeters, which measure blood oxygen by shining light through fingers, ears or other skin, without requiring blood sampling. Study will be used with healthy volunteers at rest.
Read the detailed description
This study will evaluate the accuracy of Nihon Kohden pulse oximeters and sensors in measuring arterial oxygen saturation (SpO₂) in healthy adult volunteers. Subjects will undergo controlled reductions in blood oxygen levels (down to 70%) while SpO₂ readings from the test devices are compared to reference values from arterial blood samples. The study is designed to meet current ISO and FDA requirements, and results may be used to support regulatory submissions. Data will be analyzed for overall accuracy and potential differences by skin tone and sex.
- Conditions
- Hypoxia
- Being tested
- Pulse Oximeter, Induced hypoxia through breathing nitrogen-air-carbon dioxide mixture
- Keywords
- Hypoxia, Pulse oximetry, SpO2, Pulse oximeter
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse OximeterDevice
OLV-4202 pulse oximeter ((SW version: 01-17)
Induced hypoxia through breathing nitrogen-air-carbon dioxide mixtureProcedure or surgery
Subjects will be placed in a seated semi-reclined position. Subjects will breathe a nitrogen-air-carbon dioxide mixture to produce the desired level of hypoxemia. Stable, safe and controlled hypoxia is obtained by breath-by-breath analysis of respiratory gas using a gas analyzer that permits the inspired gas mixture to be adjusted to achieve the desired degree of blood oxygen saturation.
Study is observational to see response of pulse oximeter. Intervention (above) is not therapeutic, rather is simply used to vary oxygen levels in subjects.
| Study group | Role | What they receive |
|---|---|---|
| Adult healthy subjects | Adult healthy subjects capable of undergoing controlled hypoxemia to the levels outlined in the desaturation profile in an at rest state Receives: Device: Pulse Oximeter; Procedure: Induced hypoxia through breathing nitrogen-air-carbon dioxide mixture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Sensor Oxygen Saturation by Arms Calculation
Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter (SpO2) to that obtained from a blood sample (SaO2) and calculating the arithmetic root mean square (Arms) error value as follows:
Arms = Square root (sum of n samples of ((SpO2i - SRi) squared) / n)
Measured: Up to 15 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start3 Dec 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 48 participants (estimated)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Nihon Kohden
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Greg Stratmann, MD, PhD, Principal investigator, University of California, San Francisco, Department of Anesthesia and Perioperative Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07408388
- Sponsor's protocol ID
- 75Ag-00030
- Status last verified
- Feb 2026
- First submitted
- 28 Nov 2025
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Company confidential.
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulse Oximeter Accuracy During Stable Hypoxia Plateaus
- ClinicalTrials.gov ID
- NCT07408388
- Acronym / sponsor ID
- 75Ag-00030
- Conditions
- Hypoxia
- Keywords
- Hypoxia, Pulse oximetry, SpO2, Pulse oximeter
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Nihon KohdenIndustry (pharma, biotech, devices)
- Study start
- 3 Dec 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to determine the accuracy of devices called pulse oximeters, which measure blood oxygen by shining light through fingers, ears or other skin, without requiring blood sampling. Study will be used with healthy volunteers at rest.
Detailed description
This study will evaluate the accuracy of Nihon Kohden pulse oximeters and sensors in measuring arterial oxygen saturation (SpO₂) in healthy adult volunteers. Subjects will undergo controlled reductions in blood oxygen levels (down to 70%) while SpO₂ readings from the test devices are compared to reference values from arterial blood samples. The study is designed to meet current ISO and FDA requirements, and results may be used to support regulatory submissions. Data will be analyzed for overall accuracy and potential differences by skin tone and sex.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Week
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult healthy subjects | – | Device: Pulse Oximeter, Procedure: Induced hypoxia through breathing nitrogen-air-carbon dioxide mixtureAdult healthy subjects capable of undergoing controlled hypoxemia to the levels outlined in the desaturation profile in an at rest state |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy adult volunteers. At least 48 new subjects will be enrolled. Subjects will be selected with reference to ISO and FDA requirements to ensure appropriate representation across skin tone categories (Monk Skin Tone scale) and sex.
Key inclusion criteria (4 listed)
- The subject is male or female, aged 18 to 50.
- The subject is in good general health with no evidence of any medical problems
- The subject is fluent in both written and spoken English.
- The subject has provided informed consent and is willing to comply with the study procedures.
Key exclusion criteria (18 listed)
- The subject has a BMI above 40
- The subject has blood pressure above 160 systolic or 95 diastolic
- The subject has a known history of heart disease, lung disease, kidney or liver disease.
- Diagnosis of asthma, sleep apnea, or use of CPAP.
- Subject has diabetes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulse OximeterOLV-4202 pulse oximeter ((SW version: 01-17) | Device | Adult healthy subjects |
| Induced hypoxia through breathing nitrogen-air-carbon dioxide mixtureSubjects will be placed in a seated semi-reclined position. Subjects will breathe a nitrogen-air-carbon dioxide mixture to produce the desired level of hypoxemia. Stable, safe and controlled hypoxia is obtained by breath-by-breath analysis of respiratory gas using a gas analyzer that permits the inspired gas mixture to be adjusted to achieve the desired degree of blood oxygen saturation. Study is observational to see response of pulse oximeter. Intervention (above) is not therapeutic, rather is simply used to vary oxygen levels in subjects. | Procedure or surgery | Adult healthy subjects |
Primary outcome
Accuracy of Sensor Oxygen Saturation by Arms Calculation
Time frame: Up to 15 min
Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter (SpO2) to that obtained from a blood sample (SaO2) and calculating the arithmetic root mean square (Arms) error value as follows: Arms = Square root (sum of n samples of ((SpO2i - SRi) squared) / n)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: No. Company confidential.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Greg Stratmann, MD, PhD principal investigator
University of California, San Francisco, Department of Anesthesia and Perioperative Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoxia, run by Nihon Kohden at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of Sensor Oxygen Saturation by Arms Calculation (time frame: Up to 15 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.