Hypoxia and Hemodilution Testing in Healthy Adult Volunteers

March 25, 2026 updated by: Nihon Kohden
This study will collect physiological measurements in healthy adult volunteers under controlled hypoxia and hemodilution conditions.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

7

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  1. In good general health with no evidence of significant medical problems.
  2. Fluent in both written and spoken English.

4. Has provided written informed consent and is willing to comply with study procedures.

Exclusion Criteria:

  1. BMI above 30.
  2. History of heart, lung, kidney, or liver disease.
  3. Diagnosis of asthma, sleep apnea, or use of CPAP.
  4. Diabetes mellitus.
  5. Clotting disorders.
  6. Hemoglobinopathy or history of anemia (ctHb <12 g/dL for men, <11 g/dL for women, COHb >2%).
  7. Any serious systemic illness.
  8. Current smoker.
  9. Injury or abnormality at sensor sites interfering with measurements.
  10. History of fainting or vasovagal response.
  11. Sensitivity to local anesthesia.
  12. Diagnosis of Raynaud's disease.
  13. Unacceptable collateral circulation (Allen's test).
  14. Pregnant, lactating, or attempting to become pregnant.
  15. Unable or unwilling to provide informed consent or comply with study procedures.
  16. Any other condition deemed unsuitable by the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Adult healthy subjects
Adult healthy subjects capable of undergoing controlled hypoxemia and hemodilution procedures.
Device: Noninvasive Physiological Monitoring Device
Octopal R Noninvasive Pulse Wave Measuring Device DMO-8000X with TL 811S Finger Probe

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the end of treatment up to 8 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nihon Kohden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 2, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

January 31, 2028

Study Registration Dates

First Submitted

March 25, 2026

First Submitted That Met QC Criteria

March 25, 2026

First Posted (Actual)

March 31, 2026

Study Record Updates

Last Update Posted (Actual)

March 31, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 75Ag-00043

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Company confidential

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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