HypoxiaNCT07503171
Hypoxia and Hemodilution Testing in Healthy Adult Volunteers
An observational study of Hypoxia and Hemodilution, run by Nihon Kohden at 1 site in United States.
Trial summary
This study will collect physiological measurements in healthy adult volunteers under controlled hypoxia and hemodilution conditions. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypoxia, Hemodilution
- What is being tested?
- Noninvasive Physiological Monitoring Device
- Type of treatment
- Medical device
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2026to 31 Jan 2028
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy adult volunteers. At least 7 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
- In good general health with no evidence of significant medical problems.
- Fluent in both written and spoken English.
- 4. Has provided written informed consent and is willing to comply with study procedures.
Who cannot join
- BMI above 30.
- History of heart, lung, kidney, or liver disease.
- Diagnosis of asthma, sleep apnea, or use of CPAP.
- Diabetes mellitus.
- Clotting disorders.
- Hemoglobinopathy or history of anemia (ctHb <12 g/dL for men, <11 g/dL for women, COHb >2%).
Show all 16Show fewer
- Any serious systemic illness.
- Current smoker.
- Injury or abnormality at sensor sites interfering with measurements.
- History of fainting or vasovagal response.
- Sensitivity to local anesthesia.
- Diagnosis of Raynaud's disease.
- Unacceptable collateral circulation (Allen's test).
- Pregnant, lactating, or attempting to become pregnant.
- Unable or unwilling to provide informed consent or comply with study procedures.
- Any other condition deemed unsuitable by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Vital Sign Research Group
San Francisco, California, 94107
Greg Stratmann, MD, PhD, (650) 868-5155, stratman@anesthesia.ucsf.edu
About this study
This study will collect physiological measurements in healthy adult volunteers under controlled hypoxia and hemodilution conditions.
Read the detailed description
Subjects will undergo stepwise reductions in oxygen saturation and hemoglobin concentration while noninvasive monitoring data are recorded and compared with reference blood measurements.
- Conditions
- Hypoxia, Hemodilution
- Being tested
- Noninvasive Physiological Monitoring Device
- Keywords
- Pulse oximetry, Hb
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noninvasive Physiological Monitoring DeviceDevice
Octopal R Noninvasive Pulse Wave Measuring Device DMO-8000X with TL 811S Finger Probe
| Study group | Role | What they receive |
|---|---|---|
| Adult healthy subjects | Adult healthy subjects capable of undergoing controlled hypoxemia and hemodilution procedures. Receives: Device: Noninvasive Physiological Monitoring Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of Hemoglobin and Oxygen Saturation Measurements
Collect device readings of oxygen saturation and hemoglobin concentration and reference values obtained from arterial blood samples analyzed using a multi-wavelength laboratory oximeter.
Measured: From enrollment to the end of treatment up to 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start2 Apr 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion31 Jan 2028 (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
- 7 participants (estimated)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Nihon Kohden
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07503171
- Sponsor's protocol ID
- 75Ag-00043
- Status last verified
- Mar 2026
- First submitted
- 25 Mar 2026
- Last updated
- 31 Mar 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 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypoxia and Hemodilution Testing in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT07503171
- Acronym / sponsor ID
- 75Ag-00043
- Conditions
- Hypoxia, Hemodilution
- Keywords
- Pulse oximetry, Hb
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 7 participants (estimated)
- Lead sponsor
- Nihon KohdenIndustry (pharma, biotech, devices)
- Study start
- 2 Apr 2026 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 31 Mar 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.
This study will collect physiological measurements in healthy adult volunteers under controlled hypoxia and hemodilution conditions.
Detailed description
Subjects will undergo stepwise reductions in oxygen saturation and hemoglobin concentration while noninvasive monitoring data are recorded and compared with reference blood measurements.
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: Noninvasive Physiological Monitoring DeviceAdult healthy subjects capable of undergoing controlled hypoxemia and hemodilution procedures. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy adult volunteers. At least 7 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 (3 listed)
- In good general health with no evidence of significant medical problems.
- Fluent in both written and spoken English.
- 4. Has provided written informed consent and is willing to comply with study procedures.
Key exclusion criteria (16 listed)
- BMI above 30.
- History of heart, lung, kidney, or liver disease.
- Diagnosis of asthma, sleep apnea, or use of CPAP.
- Diabetes mellitus.
- Clotting disorders.
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 |
|---|---|---|
| Noninvasive Physiological Monitoring DeviceOctopal R Noninvasive Pulse Wave Measuring Device DMO-8000X with TL 811S Finger Probe | Device | Adult healthy subjects |
Primary outcome
Collection of Hemoglobin and Oxygen Saturation Measurements
Time frame: From enrollment to the end of treatment up to 8 hours
Collect device readings of oxygen saturation and hemoglobin concentration and reference values obtained from arterial blood samples analyzed using a multi-wavelength laboratory oximeter.
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 31 Mar 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.
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 and Hemodilution, 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 3 inclusion and 16 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: opening soon, as of the sponsor's last update on 31 Mar 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?
Contact Greg Stratmann, MD, PhD ((650) 868-5155, stratman@anesthesia.ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collection of Hemoglobin and Oxygen Saturation Measurements (time frame: From enrollment to the end of treatment up to 8 hours). 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 31 Mar 2026.